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.
This prospective
We compared pain relief after total hip arthroplasty using periarticular intraoperative injection along with single dose post operative injection of local anesthetic (THA) with the well-established practice of epidural infusion. 70 patients undergoing elective THA under combined spinal anaesthesia were randomly assigned to receive either (1) continuous epidural infusion (group B) or (2) infiltration around the hip joint with a mixture of 100 ml of bupivacaine (2 mg/ml) + 1ml ketorolac (30mg/ml) and 0.5ml epinephrine (1mg/ml) at the conclusion of surgery combined with one postoperative intraarticular injection of 20 ml. of Bupivacaine 0.5% + 1ml ketorolac (30mg/ml)+ 0.5 ml. epinephrine (1mg/ml) through an intraarticular catheter (group A). All patients received acetoaminophen 1gm 8 hourly for 72 hrs and injection ketoralac 30mg every 6 hourly IV(15mg if >65 yr 30mg if <65 yr). Breakthrough pain in any group (VAS >7) was treated by injection fentanyl 20 μg bolus at 10 min. interval till VAS reduced to < 4. If VAS 4–7 injection tramadol 50mg IV was given if VAS continued to be >4 after 15 min. then injection fentanyl 20 μg bolus was given at 10 min interval till VAS <4.Background
Methods
To compare the outcomes for trochanteric fractures treated with
a sliding hip screw (SHS) or a cephalomedullary nail. A total of 400 patients with a trochanteric hip fracture were
randomised to receive a SHS or a cephalomedullary nail (Targon PFT).
All surviving patients were followed up to one year from injury.
Functional outcome was assessed by a research nurse blinded to the
implant used.Aims
Patients and Methods
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
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.
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.
This multi-centre single-blind randomised control trial compared outcomes in patients with acute displaced mid-shaft clavicle fractures treated either by primary open reduction and plate fixation (ORPF), or non-operative treatment (NT). Two-hundred patients were randomised to receive either ORPF or NT. Functional assessment was conducted up to one-year using DASH, SF-12 and Constant scores (CS). Union was evaluated using radiographs and CT. Rate of non-union was significantly reduced after ORPF (1 following ORPF, 16 following NT, odds ratio=0.07, 95% CI=0.01–0.50, p=0.0006). 7 patients had delayed-union after NT. Group allocation to ORPF was independently predictive of development of non-union. DASH and CS were significantly better in the ORPF group 3-months post-surgery, but not at one-year (mean DASH = 6.2 after NT versus 3.7 after ORPF, p=0.09; mean CS = 86.1 after NT versus 90.7 after ORPF, p=0.05). Group allocation was not predictive of one-year outcome. Non-union was the only factor independently predictive of one-year functional outcome. There were no significant differences in time off work or subjective scores. Five patients underwent revision for complications after ORPF. 10 patients underwent metalwork removal. Treatment cost was significantly greater after ORPF (p=0.001). ORPF reduces rate of non-union compared with NT and is associated with better early functional outcomes. Improved outcomes are not sustained at one-year. Differences in functional outcome appear to be mediated by prevention of non-union from ORPF. ORPF is more expensive and associated with implant-related complications not seen with NT. Our results do not support routine primary ORPF for displaced mid-shaft clavicle fractures.
Anterior knee pain post Total knee Replacement (TKR) has been reported to be as high as 49%. The source is poorly understood; both the peripatellar soft tissues and the infrapatellar fat pad have been implicated. Immunohistochemical studies demonstrate hyperinnervation of the peripatellar soft tissues. In theory circumferential electrocautery denervates the patella. However there is little evidence that this practice translates into improved clinical outcomes This study aimed to find the effect on clinical outcome, of intraoperative circumpatellar electrocautery in patients undergoing TKR. 200 patients undergoing primary TKR were randomised to circumferential circumpatellar electrocautery or nothing. Patients were assessed for Visual (VAS) for anterior knee pain and Oxford Knee Score (OKS) preoperatively, 3 months, 6 months and 1 year post-procedure. Patients and assessors were blinded to treatment allocation until the end of the study. There were 91 patients in the electrocautery group and 94 controls. The mean VAS improvement from pre-op to one year was 3.8 in both groups. The mean improvement in OKS was 16.6 points in the control and 17.7 in the electrocautery group (p= 0.40). There were no significant differences between the two groups in terms of VAS or OKS at any other time. Although previous studies have conflicting outcomes, to our knowledge this is the first prospective randomised controlled blinded trial of significant power, to evaluate the effect of peripatellar diathermy in TKR. We conclude that denervation electrocautery of the patella makes no difference to the clinical outcomes of TKR.
The best surgical treatment of lateral epicondylitis remains uncertain. Recently radiofrequency microtenotomy (RFMT) has been proposed as a suitable surgical treatment. We aim to compare open release with RFMT and present the results of our randomised controlled trial. Patients with symptoms of tennis elbow for at least 6 months who had failed to respond to conservative management were included in the trial. They were randomised to open release or RFMT. Outcome measures included grip strength, pain and DASH scores. 41 patients were randomised, 23 to RFMT and 18 to open release, 2 patients withdrew from the study. Our results show that both treatments give a significant benefit at all time points for DASH and pain scores, but only open release gives a significant improvement in grip strength. Comparing the two treatments the only significant difference is the open group have better pain scores at 6 weeks, but this is not seen at later follow up. In conclusion both groups have shown benefit from the treatments, but one is not shown to be clearly superior.
The peri-operative analgesic management of patients having either Total Knee Replacement (TKR) or Unicompartmental Knee Replacement (UKR) is an area that continues to have prominence, driven in part by the desire to reduce hospital stay, while maintaining high patient satisfaction. This is particularly relevant in the current climate of healthcare cost savings. We evaluated the role of “top up” intra-articular local anaesthetic injection after identifying that an appreciable number of patients in the unit suffered “breakthrough pain” on the first post-op day, when the effects of local analgesia are wearing off. 43 patients, who were scheduled to have a cemented Oxford UKR, were prospectively recruited and randomised. All patients had the same initial anaesthetic regime of general anaesthesia, femoral nerve block and intra-operative intra-articular infiltration of the cocktail. All patients had a 16G multi-holed epidural catheter placed intra-articularly prior to wound closure. Patients had the same operative technique, post operative rehabilitation and rescue analgesia. An independent observer recorded post-operative pain scores using a visual analogue score (1–10) every 6 hours and any rescue analgesia that was required. On the morning after surgery, 22 patients, (Group I), received 20 mls of 0.5% bupivicaine through the catheter whilst 21 patients, (Group II), had 20 mls of normal saline by the same observer, (who was blinded to the contents of the solution being injected), after which the catheter was removed.Introduction
Method
We conducted a multicentre two arm double blind randomised controlled trial to assess efficacy of pulsed ultrasound for accelerating the rate of bone healing. Sixty-two skeletally mature adults undergoing limb lengthening, of between 2.5cm to 10cm by distraction osteogenesis, at the proximal tibia using an Ilizarov frame were randomised to either an active or a placebo (control) ultrasound device. Primary outcome measure was time ready for removal of frame after adjusting for distraction length (days/cm) for both intension to treat (ITT) and per protocol (PP) patients. The time at which the frame was removed was determined by the maturation of the regenerate bone. Secondary outcomes were return to weight bearing and covariates affecting time to frame removal. The baseline characteristics of the two groups were well balanced, and 90% of patients were managed and followed up as PP. There was no difference in the time to frame removal between the two groups for the ITT (5.0days/cm, p=0.23) or the PP (10.1days/cm, p=0.054). There was no difference in return to weight bearing between the two groups, after adjusting for distraction length, for the ITT or PP patients (p>0.5). Smoking was the only covariate identified to increase the frame removal time (hazard ratio 0.46, 95% confidence interval 0.22 to 0.96; p=0.04). This trial demonstrated no difference in bone healing between those who underwent pulsed ultrasound and those who did not. Smoking was observed to have a significant inhibitory effect on bone healing.
To assess efficacy of pulsed ultrasound for accelerating regenerate consolidation. A multicentre two arm patient and assessor double blind RCTObjective:
Design:
There is limited long term evidence to support instrumented fusion as an adjunct to decompression for foraminal stenosis in the presence of single level degenerative disc disease. We report the long term outcome of a prospective randomised controlled trial. Forty-four patients with single-level disc disease were randomly assigned to three groups (spinal decompression (Group 1), decompression and instrumented posterolateral fusion (Group 2), or decompression and instrumented posterolateral fusion plus transforaminal interbody fusion (Group 3). Spinal disability (Dallas, Roland Morris, and Lower Back Outcome Score [LBOS]), and quality of life (EuroQol (EQ) and short form (SF-) 36 questionnaires) were assessed before and at after surgery by independent researchers. At mean of 15 years follow up 33 (75%) patients were available for assessment. All groups observed a significant improvement in the EQ-5D at final follow up. Group 1 demonstrated significantly better functional outcome at final follow up according to the Dallas, Roland Morris, LBOS, and EQ-5D (3L and VAS) scores when compared to the other two groups (p<0.01). The SF-36 score demonstrated that group 1 had significantly better generic health scores compared to groups 2 and 3. Regression analysis was used to adjust for the differences in general health between the groups and demonstrated no significant difference between the groups in the spine specific scores: Dallas (p>0.15), Roland Morris (p>0.37), or the LBOS (p>0.32). Fusion in combination with decompression for the treatment of foraminal stenosis and single level degenerative disc disease offers no long term functional benefit over decompression in isolation.
This ongoing prospective RCT compares two surgical approaches with respect to accuracy of guidewire and tibial nail position. 29 patients with tibial fractures were randomised to semi-extended (SE) or standard (S) approaches of tibial nail insertion. Fluoroscopy obtained guidewire and final nail position. The SE approach is more proximal with the guidewire inserted posterior to the patella, theoretically allowing more accurate wire and nail placement. Measurements were taken in both planes of the nail and guidewire to determine deviation from optimum angle of insertion (relative to the long axes of the tibial shaft). 14 and 15 patients were treated with semi-extended and standard approaches respectively. The semi-extended approach results in better guidewire and nail placement in both planes with mean deviation from the optimal angle of insertion as below: Guidewire AP 4.5° (SE) versus 4.04° (S) Lateral 24.59° (SE) versus 33.36° (S) Nail AP 3.21° (SE) versus 3.68° (S) Lateral 17.73° (SE) versus 24.04° (S) Anterior knee pain may be due to excessive anterior placement of the nail. We assessed anterior placement of the guidewire and nail in the lateral plane. This was expressed as a percentage from the anterior cortex of the tibia. Mean results are below: Guidewire 9.7% (SE) versus 9.3% (S) Nail 19.5% (SE) versus 16.3% (S) Semi-extended nailing may allow for better guidewire position and as such nail placement. This may reduce anterior knee pain.
The aims of this study were to undertake a prospective randomised trial to compare functional outcome, and range of motion after treatment of medial collateral ligament injuries by either early unprotected mobilisation or mobilisation with a hinged brace. Patients were randomised into either unprotected mobilisation or mobilisation with a hinged brace. Assessments occurred at 2 weeks, 6 weeks, 3 months and 6 months. Outcome measures included validated questionnaires (International Knee Documentation Committee and Knee Injury and Osteoarthritis Outcome Score scores), range of motion measurements and strength testing. Eighty six patients (mean age 30.4) were recruited. There were 53 men and 33 women. The mode of injury was sport in 56 patients (65%) with football, rugby and skiing being the most common types of sport involved. The mean time to return to full weight bearing was 3 weeks in both groups. The mean time to return to work was 4.6 weeks in the braced group and 4.1 weeks in the non-braced group (p=0.79). Return to running was at a mean of 14.3 weeks in the braced group and 12.8 weeks in the non-braced group (p=0.64). Return to full sport was 22 weeks in the braced group and 22.1 weeks in the non-braced group (p=0.99). There was no significant difference in range of movement or pain scores between the two groups at 2,6,12 and 24 weeks. The use of a hinged knee brace does not influence recovery after a medial collateral injury.
Open reduction and internal fixation (ORIF) of ankle fractures is associated with well known complications including wound dehiscence and infection, construct failure and symptomatic metalwork. A technique of intramedullary fibular nailing has been developed that requires only minimal incisions, is biomechanically stronger than ORIF and has low-profile hardware. We hypothesized that fibular nailing would result in a rate of reduction and union comparable to ORIF, with a reduced rate of wound and hardware problems. 100 patients over the age of 65 years with unstable ankle fractures requiring fixation were randomised to undergo fibular nailing or ORIF. Outcome measures assessed over the 12 postoperative months were wound complications, accuracy of reduction, Olerud and Molander score (OMS), and total cost of treatment. The mean age was 74 years (range 65–93) and 75 patients were women, all had some form of comorbidity. Significantly fewer wound infections occurred in the fibular nail group (p=0.002). Eight patients (16%) in the ORIF group developed lateral-sided wound infections, two of these developed a wound dehiscence requiring further surgical intervention. No infections or wound problems occurred in the fibular nail group and at 1 year patients were significantly happier with the condition of their scar (p=0.02), and had slightly better OMS scores (p=ns). The overall cost of treatment in the fibular nail group was less despite the higher initial cost of the implant. The fibular nail allows accurate reduction and secure fixation of ankle fractures with a significantly reduced rate of soft-tissue complications when compared with ORIF.
We have previously reported that fibular nailing in the elderly is associated with a significantly reduced complication rate and greater cost-effectiveness when compared to ORIF. The aim of this study was to compare the outcomes of fibular nailing to ORIF in patients under the age of 65. 100 patients aged 18 to 64 were randomly allocated between groups. Outcomes assessed over two years post-operatively included: development of wound complications or radiographic arthritis, the accuracy of reduction and patient satisfaction. The mean age was 44, 25% of patients were smokers and 35% had some form of comorbidity of whom three were diabetic. 27 injuries occurred after sport and two after assault the remainder occurred after a simple fall from a standing height. Superficial wound infections occurred in two patients in each group. Six patients requested removal of the nail, and six patients requested plate and screw removal. Patient reported outcome scores were comparable for the two groups. Two failures of fixation occurred in the fibular nail group; one in a patient with neuropathy. One failure of fixation occurred in the ORIF group. All other patients went on to an anatomical union without complication. Patient satisfaction with the surgical scar was higher after fibular nailing (visual analogue scale mean 0.75, range 0–5) than for ORIF (mean 1.5, range 0–7). The fibular nail allows accurate reduction and secure fixation of ankle fractures with comparable radiographic and patient-reported outcomes to ORIF at two years and a greater patient satisfaction with the appearance of the surgical scars.
In fractures electrical currents generated by piezoelectric and junctional diode effects initiate and augment healing. Conductive fixators may interfere with these currents causing delayed/nonunion which can be avoided by non conductive fixators, facilitating osteosynthesis. Null hypothesis of no difference and two tailed alternate hypothesis of any could be better was used. Impugn change in Electrical properties for demarcating union rate. Patients of Gustillo's grade I and II tibia fractures were randomised in conductive and non conductive fixator groups in a blinded manner. Electrical and clinico-radiological properties were compared every two weeks for 20 weeks, recoding magnitude and significant difference. Capacitance(p=0.03), Impedance(p=0.002), Inductance(p=0.01) and Reactance(p=0.02) are the electrical parameters which not only demarcated union rate but orchestrated diagnosis of fracture healing. In Non-conducting group, after removal of fixator at week 10, Local Tenderness was consistently absent, Rust Score was higher at week 18 and 20(p=0.01), absence of abnormal mobility was 58% higher and 100% at week 12(p < 0.05), Presence of weight bearing was higher from week 16(OR=15, p=0.03), presence of transmitted movement was 2.4 times higher at week 10(95% CI=0.17–34.93, p=0.52) and was 100% at week 14. Fractures heal at a faster rate if fixed by insulated non-conducting external fixators. Electrical parameters can be used to demarcate and monitor fracture healing.
The cement used for hemiarthroplasties by the authors and many other surgeons in the UK is Palacos® (containing 0.5g Gentamicin). Similar cement, Copal® (containing 1g Gentamicin and 1g Clindamycin) has been used in revision arthroplasties. We aim to investigate the effect on SSI rates of doubling the gentamicin dose and adding a second antibiotic (clindamycin) to the bone cement in hip hemiarthroplasty. We randomised 848 consecutive patients undergoing cemented hip hemiarthroplasty for fractured NOF into two groups: Group I, 464 patients, received standard cement (Palacos®) and Group II, 384 patients, received high dose, double antibiotic-impregnated cement (Copal®). We calculated the SSI rate for each group at 30 days post-surgery. The patients, reviewers and statistician were blinded as to treatment group. The demographics and co-morbid conditions were statistically similar between the groups. The combined superficial and deep SSI rates were 5 % (20/394) and 1.7% (6/344) for groups I and II respectively (p=0.01). Group I had a deep infection rate 3.3 %(13/394) compared to 1.16% (4/344) in group II (p=0.082). Group I had a superficial infection rate 1.7 % (7/394) compared to 0.58% (2/344) in group II (p=0.1861). 33(4%) patients were lost to follow up, and 77 (9%) patients were deceased at the 30 day end point. Using high dose double antibiotic-impregnated cement rather than standard low dose antibiotic-impregnated cement significantly reduced the SSI rate (1.7% vs 5%; p=0.01) after hip hemiarthroplasty for fractured neck of femur in this prospective randomised controlled trial.