We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences. The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded.Aims
Methods
The incidence of DVT and need for thrombo-prophylaxis following isolated distal lower extremity fractures is unknown. The purpose of this study was to determine whether or not thrombo-prophylaxis with low molecular weight heparin was needed in this trauma population. A Multicentered Prospective
This prospective
INTRODUCTION: CTS is the most common nerve entrapment syndrome. Repeated flexion and extension activities of the wrist coupled with certain finger flexion causes oedema and compression of the median nerve within the carpal tunnel of the wrist. Several treatment options, both conservative and surgical are available to relieve the pressure on the median nerve. Although studies support the efficacy of splinting for CTS the length of splinting, type of splints, day or night use and the effects on other variables are still less agreed. MATERIALS AND METHODS: A
Background. Total hip replacement (THR) and total knee replacement (TKR) are usually effective at relieving pain; however, 7–23% of patients experience chronic post-surgical pain. These trials aimed to investigate the effect of local anaesthetic wound infiltration on pain severity at 12 months after primary THR or TKR for osteoarthritis. Methods. Between November 2009 and February 2012, 322 patients listed for THR and 316 listed for TKR were recruited into a single-centre double-blind randomised controlled trial. Participants were randomly assigned (1:1) to receive local anaesthetic infiltration and standard care or standard care alone. Participants and outcomes assessors were masked to group allocation. The primary outcome was pain severity on the WOMAC Pain scale at 12 months post-surgery. Analyses were conducted using intention-to-treat and per-protocol approaches. Ethics approval was obtained from Southampton and South West Hampshire Research Ethics Committee. Results. In the hip trial, patients in the intervention group had significantly less pain at 12 months post-operative than patients in the standard care group (differences in means 4.74; 95% CI 0.95, 8.54; p=0.015), although the difference was not clinically significant. Post-hoc analysis found that patients in the intervention group were more likely to have none to moderate pain than severe pain at 12 months than those in the standard care group (odds ratio 10.19; 95% CI 2.10, 49.55; p=0.004). In the knee trial, there was no strong evidence that the intervention influenced pain severity at 12 months post-operative (difference in means 3.83; 95% CI −0.83, 8.49; p=0.107). Conclusions. In conclusion, routine use of infiltration could be beneficial in improving long-term pain relief for some patients after THR. Level of evidence.
Introduction and Aims:
Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial. DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment.Aims
Methods
Acute achilles tendon ruptures are increasing in incidence and occur in 18 per 100 000 people per year, however there remains a lack of consensus on the best treatment of acute ruptures.
Objectives: To compare the results of various surgical approaches to the knee in primary total knee arthroplasty (TKA) surgery. Design: Systematic review with meta-analysis. Data Sources: Cochrane Bone, Joint, and Muscle Trauma group trials register (2007), Cochrane central register of controlled trials (Cochrane Library issue 2, 2007), Medline (1950–2007), Embase (1974–2007), CINAHL (1982–2007), Pubmed, SCOPUS and ZETOC. Review Methods:
Object: To assess the benefit of prescribed Iron supplementation on the recovery of patient’s Haemoglobin level after elective joint replacement. Design: A Prospective,
Objectives: To compare the results of various surgical approaches to the knee in primary arthroplasty surgery. Design: Systematic review with meta-analysis. Data Sources: Cochrane Bone, Joint, and Muscle Trauma group trials register (2007), Cochrane central register of controlled trials (Cochrane Library issue 2, 2007), Medline (1950 to February 2007), Embase (1974 to February 2007), CINAHL (1982 to February 2007), Pubmed, SCOPUS and ZETOC. If data was insufficient trialists were contacted via telephone, email or letter. Review methods:
Introduction: After total knee arthroplasty (TKA) patients develop marked asymmetrical quadriceps femoris (QFM) weakness due to neurological activation deficits and muscle atrophy; this is associated with a slow (type I) to fast (type II) shift in myosin heavy chain (MHC) expression. Preoperative resistance training (prehabilitation) has been shown to improve strength and function after TKA however is considered costly and labour intensive. Neuromuscular electrical stimulation (NMES) offers the potential for unsupervised training, although its role in prehabilitation has not been investigated. Aims: Determine changes in myosin heavy chain (MHC) mRNA expression following preoperative NMES. Evaluate the ability of NMES prehabilitation to improve strength and functional recovery post-TKA. Methods:
Prospective
The longitudinal midline and medial-parapatellar incision are commonly used in Total Knee Arthroplasty (TKA). Medial-parapatellar incision n offers a smaller wound, avoids creation of thin skin flaps and easier exposure in obese patients. This incision creates a lateral skin flap which may be subject to poor blood supply and delayed wound healing. We undertook a
Summary.
Background: The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of
Background: Neck pain is a common problem accounting for up to 22% of the workload of physiotherapists. Many different approaches are used and the evidence for these is unclear. Purpose: To evaluate the effectiveness of a brief physiotherapy intervention (1–3 sessions) for patients with neck pain in the primary care setting, taking preferences into account. Method: A
A fracture of the hip is the most common serious orthopaedic
injury, and surgical site infection (SSI) is one of the most significant
complications, resulting in increased mortality, prolonged hospital
stay and often the need for further surgery. Our aim was to determine
whether high dose dual antibiotic impregnated bone cement decreases the
rate of infection. A quasi-randomised study of 848 patients with an intracapsular
fracture of the hip was conducted in one large teaching hospital
on two sites. All were treated with a hemiarthroplasty. A total
of 448 patients received low dose single-antibiotic impregnated
cement (control group) and 400 patients received high dose dual-antibiotic impregnated
cement (intervention group). The primary outcome measure was deep
SSI at one year after surgery.Aims
Patients and Methods
This randomised trial evaluated the outcome of
a single design of unicompartmental arthroplasty of the knee (UKA) with
either a cemented all-polyethylene or a metal-backed modular tibial
component. A total of 63 knees in 45 patients (17 male, 28 female)
were included, 27 in the all-polyethylene group and 36 in the metal-backed
group. The mean age was 57.9 years (39.6 to 76.9). At a mean follow-up
of 6.4 years (5 to 9.9), 11 all-polyethylene components (41%) were
revised (at a mean of 5.8 years; 1.4 to 8.0) post-operatively and
two metal-backed components were revised (at one and five years).
One revision in both groups was for unexplained pain, one in the
metal-backed group was for progression of osteoarthritis. The others
in the all-polyethylene group were for aseptic loosening. The survivorship
at seven years calculated by the Kaplan–Meier method for the all-polyethylene
group was 56.5% (95% CI 31.9 to 75.2, number at risk 7) and for
the metal-backed group was 93.8% (95% CI 77.3 to 98.4, number at
risk 16) This difference was statistically significant (p <
0.001).
At the most recent follow-up, significantly better mean Western
Ontario and McMaster Universities Arthritis Index Scores were found
in the all-polyethylene group (13.4 This randomised study demonstrates that all-polyethylene components
in this design of fixed bearing UKA had unsatisfactory results with
significantly higher rates of failure before ten years compared
with the metal-back components. Cite this article:
A total of 219 hips in 192 patients aged between
18 and 65 years were randomised to 28-mm metal-on-metal uncemented
total hip replacements (THRs, 107 hips) or hybrid hip resurfacing
(HR, 112 hips). At a mean follow-up of eight years (6.6 to 9.3)
there was no significant difference between the THR and HR groups
regarding rate of revision (4.0% (4 of 99) Cite this article:
The purpose of this study was to determine whether
patients with a burst fracture of the thoracolumbar spine treated
by short segment pedicle screw fixation fared better clinically
and radiologically if the affected segment was fused at the same
time. A total of 50 patients were enrolled in a prospective study
and assigned to one of two groups. After the exclusion of three
patients, there were 23 patients in the fusion group and 24 in the
non-fusion group. Follow-up was at a mean of 23.9 months (18 to
30). Functional outcome was evaluated using the Greenough Low Back
Outcome Score. Neurological function was graded using the American
Spinal Injury Association Impairment Scale. Peri-operative blood transfusion requirements and duration of
surgery were significantly higher in the fusion group (p = 0.029
and p <
0.001, respectively). There were no clinical or radiological
differences in outcome between the groups (all outcomes p >
0.05).
The results of this study suggest that adjunctive fusion is unnecessary
when managing patients with a burst fracture of the thoracolumbar
spine with short segment pedicle screw fixation.
In a randomised trial involving 598 patients
with 600 trochanteric fractures of the hip, the fractures were treated with
either a sliding hip screw (n = 300) or a Targon PF intramedullary
nail (n = 300). The mean age of the patients was 82 years (26 to
104). All surviving patients were reviewed at one year with functional
outcome assessed by a research nurse blinded to the treatment used.
The intramedullary nail was found to have a slightly increased mean
operative time (46 minutes ( In summary, both implants produced comparable results but there
was a tendency to better return of mobility for those treated with
the intramedullary nail.
Avulsion fractures of the base of the fifth metatarsal are some of the commonest foot injuries. The robust scientific evidence on the optimal non-operative treatment of these fractures is scant. We designed and conducted a prospective randomised non-inferiority controlled trial of symptomatic treatment versus cast immobilisation with the null hypothesis that cast immobilisation gave substantial benefit over the symptomatic treatment in terms of patient reported outcome measures(PROMs). The alternative hypothesis was that symptomatic treatment was not inferior. The primary outcome was the validated Visual Analogue Scale Foot and Ankle (VAS FA) score ranging from 0 to 100. The non-inferiority boundary was set at −10 points. Power sizing determined a minimum of 12 patients per group. Anticipating a significant loss to follow up, 60 patients of 16 years of age or older were randomised to receive either below knee walking cast immobilisation (n = 24) or symptomatic double- elasticated bandage (n = 36) for 4 weeks. Secondary outcome measures were EuroQol-5D, and American Orthopaedic Foot and Ankle Society scores. Data was analysed at the baseline, 4 weeks, 3 months and 6 months post injury by a clinician blinded to a treatment arm.Background
Methods
Tranexamic acid is an antifibrinolytic drug that has been shown to successfully reduce postoperative blood loss in total knee and hip arthroplasty. However, the efficacy of TXA following total shoulder arthroplasty has not been reported. The purpose of the present study was to evaluate the impact of intravenous TXA on postoperative blood loss and transfusion rates in total shoulder reconstruction.Background
Purpose
Recruitment to time and target in clinical trials is a key challenge requiring careful estimation of numbers of potential participants. The SCOPiC trial ((HTA 12/201/09) (ISRCTN75449581)) is investigating the clinical and cost-effectiveness of stratified care for patients with sciatica in primary care. Here, we describe the approaches followed to achieve recruitment of our required sample size (n=470), the challenges encountered and required adaptations. We used recruitment data from the SCOPiC trial and its internal pilot, to show the differences between estimated and actual numbers of patients from consultation to participation in the trial. Patients were consented to the trial if they had a clinical diagnosis of sciatica (with at least 70% confidence) and met the trial eligibility criteria.Background
Methods
To introduce a new robot-assisted surgical system for spinal posterior fixation which called TiRobot, based on intraoperative three-dimensional images. TiRobot has three components: the planning and navigation system, optical tracking system and robotic arm system. By combining navigation and robot techniques, TiRobot can guide the screw trajectories for orthopedic surgeries. In this randomised controlled study approved by the Ethics Committee, 40 patients were involved and all has been fully informed and sign the informed consent. 17 patients were treated by free-hand fluoroscopy-guided surgery, and 23 patients were treated by robot-assisted spinal surgery. A total of 190 pedicle screws were implanted. The overall operation times were not different for both groups. None of the screws necessitated re-surgery for revised placement. In the robot-assisted group, assessment of pedicle screw accuracy showed that 102 of 102 screws (100%) were safely placed (<2 mm, category A+B). And mean deviation in entry point was 1.70 +/− 0.83mm, mean deviation in end point was 1.84 +/− 1.04mm. In the conventional freehand group, assessment of pedicle screw accuracy showed that 87 of 88 (98.9%) were safely placed (<2 mm, category A+B), 1 screw fall in category C, mean deviation in entry point was 3.73 +/− 2.28mm, mean deviation in end point was 4.11 +/− 2.31mm. This randomised controlled study verified that robot-assisted pedicle screw placement with real-time navigation is a more accuracy and safer method, and also revealed great clinical potential of robot-assisted surgery in the future.
Prosthetic joint infection (PJI) is a much feared complication to arthroplasty with significant patient morbidity. Rifampin is increasingly used in staphylococcal PJIs treated with debridement and retention of the prosthesis. The evidence supporting rifampin combination therapy in PJIs is limited due to the lack of controlled studies. The aim of this study is to evaluate the effect of adding rifampin to conventional antimicrobial therapy in early staphylococcal PJIs treated with debridement and retention. In this multicentre randomized controlled trial, 99 patients with PJI after hip and knee arthroplasties were enrolled. All patients underwent a standardized surgical debridement. 65 patients had PJI caused by staphylococci and further included in the study. They were randomly assigned to receive rifampin or not in addition to standard antimicrobial therapy with cloxacillin, or vancomycin in case of methicillin resistance. They received parenteral antibiotics for two weeks, then oral antibiotics for 4 weeks. In case of methicillin resistance, vancomycin was administered i.v. for 6 weeks. The primary end point was no signs of infection after 2 wears follow-up.Aim
Method
The aim of this prospective randomized controlled trial was to compare patient reported and functional outcomes, complications and costs for displaced olecranon fractures managed with either tension band wire (TBW) or plate fixation. We performed a registered prospective randomized, single blind, single centre trial in 67 patients aged between 16–74 years with an acute isolated displaced fracture of the olecranon. Patients were randomised to either TBW (n=34) or plate fixation (n=33). The primary outcome measure was the Disability Arm Shoulder and Hand (DASH) score at one-year. The baseline demographic and fracture characteristics of the two groups were overall comparable. The one-year follow-up was 85percnt;. There was a significant improvement in elbow function over the 12 months following injury in both groups (p<0.001). At one-year following surgery the DASH for the TBW group was not statistically different to the plate fixation group (12.8 vs 8.5; p=0.315). There was no significant difference between groups in terms of range of movement, Broberg and Morrey Score, Mayo Elbow Score or the DASH at all assessment points over the one-year following injury (all p≥0.05). Complication rates were significantly higher in the TBW group (63percnt;vs38percnt;; p=0.042), predominantly due to a significantly higher rate of symptomatic metalwork removal (50percnt;vs22percnt;; p=0.021). In active patients with an isolated displaced fracture of the olecranon, no difference was found in the patient reported outcome between TBW and plate fixation at one year following surgery. The complication rate is higher following TBW fixation due to a high rate of symptomatic metalwork removal.
A recent meta-analysis published in the British Medical Journal suggested an increased risk of infection, but none of the studies were large enough to reach statistical significance. A prospective, randomised trial was designed at our institution to investigate the wound healing and complications related to surgery following fracture neck of femur in the elderly. The primary aim was to compare the wound problems and infection following two different methods of skin closure: Subcuticular monocryl suture to metal clips for closure of skin. The secondary aim was to look at the duration of surgery after both types of closure. We received ethical approval for this study. We screened and recruited all eligible patients admitted with acute hip fracture undergoing hemi-arthroplasty or dynamic hip screw. We recruited 541 patients in the study over the period of 3.5 years at our institution.Introduction
Objectives
Electrical stimulators are commonly used to accelerate fracture healing, resolve nonunions or delayed unions, and to promote spinal fusion. The efficacy of electrical stimulator treatment, however, remains uncertain. We conducted a meta-analysis of randomised sham-controlled trials to establish the effectiveness of electrical stimulation for bone healing. We searched MEDLINE, EMBASE, CINAHL and Cochrane Central to identify all randomised sham-controlled trials evaluating electrical stimulators in patients with acute fractures, non-union, delayed union, osteotomy healing or spinal fusion, published up to February 2015. Our outcomes were radiographic nonunion, patient-reported pain and self-reported function. Two reviewers independently assessed eligibility and risk of bias, performed data extraction, and rated overall confidence in the effect estimates according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Fifteen randomised trials met our inclusion criteria. Electrical stimulation reduced the relative risk of radiographic nonunion or persistent nonunion by 35% (95%CI 19% to 47%; 15 trials; 1247 patients; number needed to treat = 7; p < 0.01; moderate certainty). Electrical stimulation also showed a significant reduction in patient-reported pain (Mean Difference (MD) on the 100-millimeter visual analogue scale = −7.67; 95% CI −13.92 to −1.43; 4 trials; 195 patients; p = 0.02; moderate certainty). Limited functional outcome data showed no difference with electrical stimulation (MD −0.88; 95% CI −6.63 to 4.87; 2 trials; 316 patients; p = 0.76; low certainty). Patients treated with electrical stimulation as an adjunct for bone healing have a reduced risk of radiographic nonunion or persistent nonunion and less pain; functional outcome data are limited and requires increased focus in future trials.
Recently many authors have questioned the role of tourniquets in primary knee arthroplasty (TKA). Meanwhile, whether the use of an intra-articular wound drainage is an advance over the lack of a drain in TKA is controversial in the literature. This study aimed to investigate the efficacy and safety of drainage or not in TKA without a tourniquet. Eighty participants who underwent primary unilateral TKA were prospectively enrolled and were randomized to one of two techniques during surgery without a tourniquet: drainage (Group A) or non-drainage (Group B). Blood loss was monitored perioperatively. The operating time, allogeneic blood transfusion rate, thigh pain, knee pain, limb swelling, clinical outcome as measured by the hospital for special surgery (HSS) score, the ability to straight-leg raise, visual analog scale (VAS) in pain, length of stay and knee active range of motion (ROM) were also recorded. The digital radiographs taken at 6 months postoperatively were assessed for cement mantle thickness and radiolucency using the Knee Society radiographic zones.Purpose
Methods
The long-term wear performance of highly cross-linked polyethylene (HXLPE) in cemented total hip arthroplasty (THA) has rarely been reported. Here we report a prospective randomized comparative analysis of radiographic wear after a minimum follow-up of 10 years in cemented THAs with either HXLPE or conventional polyethylene (CPE), and assess its clinical relevance. From 1999 to 2001, we conducted 94 primary cemented THAs with a 22.225-mm head at our hospital as part of a prospective randomized trial. All surgeries were performed using a direct lateral approach with a trochanteric osteotomy (Dall's approach). The patients were divided into 4 groups. Twenty-six hips in group A were implanted with CPE sockets against zirconia heads and Charnley-type stems. HXLPE sockets (Aeonian, Kyocera Medical Corp) were implanted in all hips in the other 3 groups. Twenty-five hips in group B were implanted with zirconia heads and KC stems (Kyocera Medical Corp), 23 hips in group C with zirconia heads and distal cylindrical stems, and 20 hips in group D with stainless steel heads and C-stem (DePuy Inc). The sockets were highly cross-linked by gamma irradiation at a dose of 35 kGy, heat annealed at 110ºC, and sterilized with 25 kGy of gamma irradiation in nitrogen. For radiographic evaluation, anteroposterior radiograms were taken for each patient annually, and every two years postoperatively for wear analyses. Two-dimensional head penetration was measured on each postoperative radiogram using a computer-aided technique.Introduction
Patients and Methods
Bearing surfaces in Total Hip Arthroplasty (THA) may affect implant longevity and hence patient outcomes. This randomised clinical trial (RCT) determined how ceramic-on-ceramic bearing (CERAMIC) THA affected joint-specific pain, function and stiffness, and prosthesis fixation/longevity over 10 postoperative years compared with ceramic-on-highly-crosslinked-polyethylene bearing (POLYETHYLENE) THA. This is a follow-up to previously reported five year outcomes. Subjects aged less than 61 years were randomised to CERAMIC [n=48] or POLYETHYLENE [n=44] THA. Subjects were assessed using the Western Ontario McMaster Osteoarthritis Index (WOMAC) and the RAND 12-Item Health Survey (RAND-12) preoperatively, and at one, five and 10 years postoperatively. Plain radiographs were evaluated at 10 years for fixation and medical records were reviewed for revisions. Of 92 subjects, six (7%) died within 10 years; 68 (79%) survivors provided radiographic and/or clinical follow-up at 10 years postoperatively. Improvements seen at five years in both the WOMAC and RAND-12 were retained at 10 years with no group differences (p>0.48). There were no failures/loss of fixation related to bearing surfaces/wear in either group. Over 10 years, three subjects in the POLYETHYLENE group had revisions that were related to recurrent dislocation; two revisions were performed within two years of surgery and one further subject underwent revision at 7 years postoperatively. This is one of the first RCTs to examine 10 year outcomes between ceramic-on-ceramic and ceramic-on-highly-crosslinked-polyethylene bearing THA. Both bearing surfaces performed well out to 10 years in subjects who were less than 61 years at time of surgery.
The study was started in 2004 to determine the best bearing surface in the long term, and to measure the metal ion levels generated by each of the bearing surfaces. We present the latest updated results. A prospective randomised study was started in 2004 to compare the wear characteristics of Ceramic on X linked Polyethylene (C.O.P.), Ceramic on Ceramic (C.O.C), Ceramic on Metal (C.O.M.) and Metal on Metal (M.O.M) bearings. The level of Cobalt and Chrome ions in red blood cells have been documented at serial intervals, using the ICP – MS method. Aside from the bearing surfaces the rest of the implant is standard, using a Pinnacle Cup, Corail Stem and 28mm heads. 256 Cases were enrolled on the study. To date 71 cases have been lost due to death (26), revision (9) and lost to follow up (36), leaving us with 185 for follow-up. An even spread of cases in each bearing surface are still available for follow up, viz. 46 C.O.P, 48 C.O.C., 44 C.O.M. and 47 M.O.M. Average follow up is currently 4.8 years, ranging up to 9 years.Purpose Of Study
Material and methods
The use of spinal anesthesia with adjuvant intra-thecal opioids has been commonly used in total knee arthroplasty without documented clinical benefit. It has been associated with a potential increase in side effects, including nausea, vomiting, pruritus, urinary retention and oxygen usage. This double-blinded RCT investigated whether the addition of epimorph to spinal anesthesia in patients undergoing total knee arthroplasty resulted in superior pain control and decreased narcotic consumption without also causing an increase in postoperative complication rates. We performed a prospective double-blind trial in patients undergoing primary total knee arthroplasty (TKA). Patients were randomised to receive either spinal anesthesia alone or spinal anesthesia with epimorph (150 ug). All patients received infiltration of a local anesthetic cocktail intraoperatively. Both the study patients and staff measuring outcomes were blinded to the experimental treatment received during data collection. Postoperatively, visual analogue scale (VAS) for pain was recorded at 6, 12, 18, 24, 36 and 48hrs and a final value at 1 week. Narcotic use, Foley insertion, oxygen requirements, nausea, vomiting and pruritus were recorded during the course of hospitalisation. Forty-one patients were randomised into each of the spinal with epimorph and spinal alone treatment arms. The groups showed no significant differences in BMI, age, and gender distribution. In the first 12 hours postoperatively there was no difference in VAS for pain between the two groups, however there were significantly lower pain scores in the spinal alone patients at 18 hours (p=0.002), 24 hours (p=0.04) and 48 hours (p = 0.03) compared to the spinal with epimorph group. Narcotic usage was greater in the spinal group during the first 6 hours postoperatively, but beyond this time point narcotic usage was similar between the two groups. Additionally, there was a statistically significant increase in rate of complications with spinal epimorph including nausea (p=0.037) and pruritus (p=0.024). The incidence of urinary retention was greater in the spinal epimorph group, however this did not reach statistical significance. This study demonstrates no clinical benefit with the addition of intra-thecal opioids to spinal anesthetic in primary TKA. In addition to a failing to reduce VAS pain scores and overall narcotic consumption, increased complication rates were seen. For these reasons, this study does not support the use of epimorph in addition to spinal anesthesia for pain control in TKA.
We report a single-centre, prospective, randomised study for pedicle screw insertion, by using a Computer Assisted Surgery (CAS) technique with three dimension (3D) intra-operative images intensifier versus conventional surgical procedure. 143 patients (68 women and 75 men) were included in this study. 72 patients underwent conventional surgery (C = conventional). 71 patients were operated on with the help of a 3D intra-operative imaging system (N = navigated). We performed 34 percutaneous surgeries in group N and 37 in group C; 25 open surgeries in group N and 35 in group C. 382 screws were implanted in group C and 174 in group N. We measured the pedicle screw running-time, and surgeon's radiation exposure. All pedicle runs were assessed according to Heary's classification by two independent radiologists on a post-operative CT.Introduction
Methods
Femoroacetabular impingement (FAI) is a condition of the hip where there is a mismatch of the femoral head and hip acetabulum. This mismatch creates abnormal contact between the bones and causes hip pain which can lead to damage, and eventually osteoarthritis of the hip. The diagnosis and treatment of FAI has become one of the most popular clinical scenarios in orthopaedic surgery, with hip arthroscopy procedures increasing exponentially over the past five years. Surgical intervention usually involves correcting the existing deformities by reshaping the ball and socket (“osteoplasty” or “rim trimming”) so that they fit together more easily while repairing any other existing soft tissue damage in the hip joint (e.g. labral repair). Although correction of the misshaped bony anatomy and associated intra-articular soft tissue damage of the hip is thought to appease impingement and improve pain and function, the current evidence is based on small, observational, and low quality studies. A lack of definitive evidence regarding the efficacy of osteochondroplasty in treating FAI fueled the design and execution of the FIRST randomized controlled trial (RCT). FIRST evaluated the impact of surgical correction of the hip impingement morphology with arthroscopic osteochondroplasty versus arthroscopic lavage on pain, function, and quality of life in adults aged 18–50 years diagnosed with non-arthritic FAI at one year. FIRST was a large definitive RCT (NCT01623843) enrolling patients with FAI requiring surgical intervention across 11 international clinical sites. Participants were randomized to either arthroscopic osteochondroplasty (shaving of bone) or lavage (washing the joint of painful inflammation debris). The primary outcome was patient-reported pain within one year of the initial surgery measured using the Visual Analogue Scale (VAS). Secondary outcomes included function, health utility, and health-related quality of life using several general and hip-centric health questionnaires. An independent, blinded adjudication committee evaluated the quality of surgery, re-operations, and other patient complications. Patients and data analysts were blinded to the treatment groups. Two-hundred and twenty participants were enrolled into the FIRST trial over a six-year period (pilot phase: N=50, from 2012–2013 and definitive phase: N=170, from 2015–2018) at 11 clinical sites in Canada, Finland, and Denmark. The FIRST results will be released at the ISAKOS annual meeting as follows. The absolute difference in rate of pain reduction between groups was XX (95% CI: YY-YY, p=X). The mean differences of the Short-Form 12 (SF-12, MCS and PCS), Hip Outcome Score (HOS), International Hip Outcome Tool (iHOT-12), and EuroQol 5-Dimensions (EQ-5D) between groups are XX (95% CI: YY-YY, p=X)…, respectively. Reoperations occurred in XX of 220 (X%) patients over the one-year follow up period (OR:XX, 95% CI: YY-YY, p=X) and the patients treated with arthroscopic osteochondroplasty conferred the following risk of reoperation within one-year compared to arthroscopic lavage (RR:XX, 95% CI: YY-YY, p=X). This RCT represents major international efforts to definitively identify the optimal treatment strategy for FAI. The results of this trial will change practice, being used to prevent chronic hip pain and loss of function caused by hip osteoarthritis.
Mid-flexion stability after total knee arthroplasty (TKA) is dependent, in large part, on implant design. Design variables include retention or sacrifice of the posterior cruciate ligament, conformity of the polyethylene tibial surface, and radius of curvature of the femoral component. In this study, we attempted to isolate the impact of femoral component design by comparing a single-radius design (SR) to a J-Curve design (JC). We selected cruciate-retaining implants to eliminate the effect of a cam-and-post mechanism. Mid-flexion performance these two designs were compared using the Lower-Quarter Y-Balance Test (YBT-LQ), as well as patient reported outcomes and measures of physical performance. The YBT-LQ is a simple functional test of unilateral lower extremity strength and balance. Reach of the contralateral limb is measured in three different directions (Figures 1–3). Our hypothesis was that the SR design would provide superior mid-flexion stability, and therefore, a greater reach distance in the YBT-LQ when compared to the JC group. Patients undergoing primary, unilateral TKA were prospectively enrolled and block randomized to receive either the SR (n=30) or JC (n=30) implant. All surgeries were performed by one surgeon using a gap-balancing technique with a cruciate-retaining implant design. Patients completed outcome measures (KOOS, KSS, UCLA Activity), performed the YBT-LQ, and completed physical performance measures (walking speed, timed up-and-go, sit-to-stand) before surgery and 1 year postoperatively. A series of 2×2 repeated measures ANOVAS (Implant group x Time) were completed.Introduction
Methods
Previous studies have demonstrated pronounced reduction of sleep quality following major surgery, which may affect postoperative pain and early recovery. This prospective, randomized, controlled trial was designed to evaluate the effect of zolpidem on sleep quality in fast-track total knee arthroplasty (TKA). 180 patients who underwent primary TKA were enrolled in this study and randomized 1:1 to receive either zolpidem (Group A) or placebo (Group B) for 6 days. VAS pain scores (rest, ambulation, flexion, and night), range of motion (ROM), opioid analgesics use, postoperative nausea and vomiting (PONV) and other complication, sleep efficacy and patients VAS satisfaction were recorded postoperatively and at 1, 3, 5 after surgery. Sleep quality was measured using the polysomnography (PSG) and Epworth Sleepiness Scale.Purpose
Methods
Current standard of care in the management of bone and joint infection commonly includes a 4–6 week course of intravenous (IV) antibiotics but there is little evidence to suggest that oral antibiotic therapy results in worse outcomes. The primary objective was to determine whether oral antibiotics are non-inferior to IV antibiotics in this setting. This was a parallel group, randomised (1:1), open label, non-inferiority trial across twenty-six NHS hospitals in the United Kingdom. Eligible patients were adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least six weeks of antibiotics and who had received ≤7 days of IV therapy from the date of definitive surgery (or the start of planned curative treatment in patients managed non-operatively). Participants were randomised to receive either oral or IV antibiotics for the first 6 weeks of therapy. Follow-on oral therapy was permitted in either arm. The primary outcome was the proportion of participants experiencing definitive treatment failure within one year of randomisation. The non-inferiority margin was set at 7.5%.Aim
Method
Whether it is best to retain the posterior cruciate ligament in the degenerated knee, i.e. using a cruciate-retaining (CR) total knee prosthesis (TKP), or to use a more constraint posterior-stabilized (PS) TKP is of debate. There are limited studies comparing the effect of both methods on implant fixation and clinical outcome, leaving it up to the surgeon to base this decision on anything but conclusive evidence. We assessed the effect of two different philosophies in knee arthroplasty on clinical outcome and tibial component migration measured with radiostereometric analysis (RSA), by directly comparing the CR and PS version of an otherwise similarly designed cemented TKP. Sixty patients were randomized and received a Triathlon TKP (Stryker, NJ, USA) of either CR (n=30) or PS (n=30) design. RSA measurements (primary outcome) and clinical scores including the Knee Society Score and Knee injury and Osteoarthritis Outcome Score were evaluated at baseline, at three months postoperatively and at one, two, five and seven years. A linear mixed-effects model was used to analyse the repeated measurements. Both groups showed a similar implant migration pattern, with a maximum total point motion at seven years follow-up of around 0.8 mm of migration (mean difference between groups 95% CI −0.11 to 0.15mm, p=0.842). Two components (one of each group) were considered to have an increased risk of aseptic loosening. Both groups improved equally after surgery on the KSS and KOOS scores and no differences were seen during the seven years of follow-up. No differences in implant migration nor clinical results were seen seven years after cruciate-retaining compared to posterior-stabilized total knee prostheses.
There is a paucity of published literature regarding the long-term outcomes of the modern generations of total joint arthroplasty (TJA) of the first metatarsophalangeal joint. Between 1999 and 2001, we recruited 63 patients into a randomised controlled trial of arthrodesis vs TJA. The 2 year results were published in 2005. At a mean follow-up 15.2 years (range 13.2–17.2), all patients from the original trial were contacted. Data were collected in the form of visual analogue score for pain (VAS), visual-Analogue-Scale Foot and Ankle (VAS FA) as well as information on any revision procedures. Data were available from all surviving patients (66 toes 53 patients). There was no difference in pain scores between the arthrodesis group and arthroplasty group 7.4 ± 15.7 vs 15.7 ± 19.7 (p=0.06). There was also no difference in the VAS FA scores as a whole 88.9 ± 12.9 vs 86.1 ± 17.1 (p = 0.47), or when divided into its 3 components (pain, function and other complaints). There was however a significant difference with regards to patient satisfaction with the arthrodesis group outperforming the TJA group: 95.5 ± 10.4 vs 83.6 ± 20.9 (p<0.01). There was a significantly higher rate of revision surgery in the TJA group when compared to the arthrodesis group (p= 0.009). At 15 years the patients that underwent arthrodesis were more satisfied and had a greater survivorship compared to TJA, however there was no difference in outcome with regards to pain or function between the two groups. Based on the results of this study arthrodesis remains the ‘gold standard’ due to excellent pain relief, high function and low risk of revision surgery.
The optimal surgical approach for patients hospitalized for moderate to severe septic bursitis is not known, and there have been no randomized trials of a one-stage compared with a two-stage (i.e., bursectomy, followed by closure in a second procedure) approach. Thus, we performed a prospective, non-blinded, randomized study of adult patients hospitalized for an open bursectomy. Patients were randomized 1:1 to a one-stage vs. a two-stage surgical approach. All patients received postsurgical oral antibiotic therapy for 7 days. These are the final results of the prospective study registered at ClinicalTrials (NCT01406652).Aim
Method
Athletes involved in repetitive overhead shoulder rotation demonstrate increased external rotation and decreased internal rotation range of motion. Deficits in internal rotation have been linked to the development of shoulder pathology. The purpose of this study is to determine if a posterior shoulder stretch program is effective in increasing dominant arm internal rotation and horizontal adduction range of motion in overhead athletes identified as having reduced mobility and posterior shoulder tightness. Thirty-seven overhead athletes in volleyball, swimming and tennis, with internal rotation range of motion deficits greater than or equal to 15°, were randomised into intervention or control groups. The intervention group performed the “sleeper stretch” daily for eight weeks while the control group performed usual activities. Independent t-tests determined whether internal rotation and horizontal adduction range of motion differences between groups were significant and two-way repeated measures analysis of variance tests measured the rate of shoulder range of motion change. Reported shoulder pain and function were also obtained at each evaluation. Significant differences were found between the intervention and control groups' internal rotation and horizontal adduction range of motion at eight weeks (p<0.001 and p=0.003 respectively) compared to baseline (zero weeks) (p=0.19 and p=0.82 respectively). Significant changes in internal rotation were detected in the intervention group at four weeks (p<0.001) with further adaptations noted at eight weeks. Horizontal adduction improved at a slower rate demonstrating significant changes at eight weeks (p=0.003). Reported shoulder pain and functional ability (p=0.002) were different between the study groups at eight weeks. Overhead, collegiate-level athletes with an internal rotation deficit greater than or equal to 15° are able to significantly increase internal rotation and horizontal adduction range of motion by performing a posterior shoulder stretch exercise for eight weeks.
To reduce several disadvantages many surgeons are not using tourniquet in TKA. Here we compared functional outcome along with pain and blood loss in sixty patients. 60 patients who underwent TKA wererandomized into a tourniquet group (n2 = 30) and a non-tourniquet group (n1 = 30). All operations were performed by the samesurgeon and follow-up was for 6 month. Primary outcomes werefunctional and clinical outcomes, as evaluated by KSS and postoperative pain. Secondary outcomes were blood loss, surgical time and visibility, extensor lag and Knee ROM, DVT and radiolucency.Introduction
Material and Method
Pain immediately following total knee arthroplasty (TKA) is often severe and can inhibit patients' rehabilitation. Recently, adductor canal blocks have been shown to provide adequate analgesia and spare quadriceps muscle strength in the early postoperative period. We devised a single injection motor sparing knee block (MSB) by targeting the adductor canal and lateral femoral cutaneous nerve with a posterior knee infiltration under ultrasound. Our primary objective was to evaluate the analgesia duration of the MSB in comparison to a standard periarticular infiltration (PAI) analgesia using patients' first rescue analgesia as the end point. Secondary outcomes measured were quadriceps muscle strength and length of stay. We randomised 82 patients scheduled for elective TKA to receive either the preoperative MSB (0.5% ropivacaine, 2.5ug/ml epinephrine, 10mg morphine, and 30mg ketorolac) or intraoperative periarticular infiltration (0.3% ropivacaine, 2.5ug/ml epinephrine, 10mg morphine, and 30mg ketorolac). Duration of analgesia, postoperative quadriceps power, and length of stay were evaluated postoperatively. Analgesic duration was found to be significantly different between groups. The MSB had a mean duration of 18.06 ± 1.68 hours while the PAI group had a mean duration of 9.25 ± 1.68 hours for a mean difference of 8.8 hours (95% CI 3.98 to 13.62), p<0.01. There were no significant differences between groups in quadriceps muscle strength power at 20 minutes (p=0.91) or 6 hours (p=0.66) after block administration. Length of stay was also not significantly different between the groups (p=0.29). Motor sparing blocks provide longer analgesia than patients receiving periarticular infiltration while not significantly reducing quadriceps muscle strength or increasing length of hospital stay.
The aim of this study was to compare the effect of a percutaneous
radiofrequency heat lesion at the medial branch of the primary dorsal
ramus with a sham procedure, for the treatment of lumbar facet joint
pain. A randomised sham-controlled double blind multicentre trial was
carried out at the multidisciplinary pain centres of two hospitals.
A total of 60 patients aged >
18 years with a history and physical
examination suggestive of facet joint pain and a decrease of ≥ 2
on a numerical rating scale (NRS 0 to 10) after a diagnostic facet
joint test block were included. In the treatment group, a percutaneous
radiofrequency heat lesion (80oC during 60 seconds per
level) was applied to the medial branch of the primary dorsal ramus.
In the sham group, the same procedure was undertaken without for
the radiofrequency lesion. Both groups also received a graded activity
physiotherapy programme. The primary outcome measure was decrease
in pain. A secondary outcome measure was the Global Perceived Effect scale
(GPE).Aims
Patients and Methods
Smaller studies indicate that yoga may be an effective treatment for chronic low back pain. We conducted a randomised trial to evaluate if yoga compared to usual care improves back function in patients with chronic or recurrent low back pain. Outcomes were assessed by postal questionnaires. The setting was 13 non-National Health Service premises. We recruited 313 adults with chronic or recurrent low back pain from primary care. 157 were randomised to usual care. 156 were randomised to a 12-class, gradually-progressing programme of yoga delivered by 12 teachers over three months. All received The Back Book. Primary outcome was back function (Roland Morris Disability Score) at three months. Secondary outcomes: back function at six and 12 months, back pain, pain self-efficacy and general health. Back function improved more in the yoga group: mean difference in changes from baseline at three (−2.17, 95% CI −3.31 to −1.03, p<0.001), six (−1.48, 95% CI −2.62 to −0.33, p=0.011) and 12 months (−1.57, −2.71 to −0.42, p=0.007). Improvement in pain self-efficacy at three and six months in the yoga group. No differences in general health and pain reduction. Two adverse events were reported by controls and 12 by the yoga group – 8 out of 12 reported pain which may have been due to yoga. 63 (40%) were not fully compliant with treatment and 23 (15%) did not attend any yoga classes.Purposes of the study and background
Summary of the methods used and the results