Total hip arthroplasty (THA) is an effective surgery for the treatment of advanced osteoarthritis but increasing numbers of these procedures are having a significant impact on healthcare budgets. One route to mitigate the increasing costs is outpatient THA, discharging patients on the same day as their surgery. The purpose of this study was to determine the cost of outpatient THA compared to standard overnight stay in hospital. This was a prospective-randomized controlled trial for patients undergoing primary THA through a direct anterior approach. Participants were randomized to be discharged on the same day as surgery, as outpatients, or on day one post-surgery, as inpatients, using a Zelen consent model. Adverse events were assessed, and participants completed self-reported cost questionnaires at two-, six- and 12-weeks post-surgery, and the WOMAC preoperatively and at 12-weeks post-surgery. We performed a cost analysis from health care payer (HCP) and societal perspectives.Introduction
Methods
Total knee arthroplasty is a successful procedure that reduces knee pain and improves function in most patients with knee osteoarthritis. Patient dissatisfaction however remains high, and along with implant longevity, may be affected by component positioning. Surgery in obese patients is more technically challenging with difficulty identifying appropriate landmarks for alignment and more difficult exposure of the joint. Patient specific instrumentation (PSI) has been introduced with the goal to increase accuracy of component positioning by custom fitting cutting guides to the patient using advanced imaging. A strong criticism of this new technology however, is the cost associated. The purpose of this study was to determine, using a prospective, randomized-controlled trial, the cost-effectiveness of PSI compared to standard instrumentation for total knee arthroplasty in an obese patient population. Patients with a body mass index greater than 30 with osteoarthritis and undergoing a primary total knee arthroplasty were included in this study. We randomized patients to have their procedure with either standard instrumentation (SOC) or PSI. At 12-weeks post-surgery patients completed a self-reported cost questionnaire and the Western Ontario and McMaster Osteoarthritis Index (WOMAC). We performed a cost-effectiveness analyses from a public health payer and societal perspective. As we do not know the true cost of the PSI instrumentation, we estimated a value of $100 for our base case analysis and used one-way sensitivity analyses to determine the effect of different values (ranging from $0 to $500) would have on our conclusions. A total of 173 patients were enrolled in the study with 86 patients randomized to the PSI group and 87 to the SOC group. We found the PSI group to be both less effective and more costly than SOC when using a public payer perspective, regardless of the cost of the PSI. From a societal perspective, PSI was both less costly, but also less effective, regardless of the cost of the PSI. The mean difference in effect between the two groups was −1.61 (95% CI −3.48, 026, p=0.091). The incremental cost-effectiveness ratio was $485.71 per point increase in the WOMAC, or $7285.58 per clinically meaningful difference (15 points) in the WOMAC. Overall, our results suggest that PSI is not cost-effective compared to standard of care from a public payer perspective. From a societal perspective, there is some question as to whether the decreased effect found with the PSI group is worth the reduced cost. The main driver of the cost difference appears to be time off of volunteer work, which will need to be investigated further. In future, we will continue to follow these patients out to one year to collect cost and effectiveness data to investigate whether these results remain past 12 weeks post-surgery.
This single-centre prospective randomised trial aimed to assess the superiority of operative fixation compared with non-operative management for adults with an isolated, closed humeral shaft fracture. 70 patients were randomly allocated to either open reduction and internal fixation (51%, n=36/70) or functional bracing (49%, n=34/70). 7 patients did not receive their assigned treatment (operative n=5/32, non-operative n=2/32); results were analysed based upon intention-to-treat. The primary outcome measure was the DASH score at 3 months. Secondary outcomes included treatment complications, union/nonunion, shoulder/elbow range of motion, pain and health-related quality of life (HRQoL). At 3 months, 66 patients (94%) were available for follow-up; the mean DASH favoured surgery (operative 24.5, non-operative 39.4; p=0.006) and the difference (14.9 points) exceeded the MCID. Surgery was also associated with a superior DASH at 6wks (operative 38.4, non-operative 53.1; p=0.005) but not at 6 months or 1yr. Brace-related dermatitis affected 7 patients (operative 3%, non-operative 18%; OR 7.8, p=0.049) but there were no differences in other complications. 8 patients (11%) developed a nonunion (operative 6%, non-operative 18%; OR 3.8, p=0.140). Surgery was associated with superior early shoulder/elbow range of motion, and pain, EuroQol and SF-12 Mental Component Summary scores. There were no other differences in outcomes between groups. Surgery confers early advantages over bracing, in terms of upper limb function, shoulder/elbow range of motion, pain and HRQoL. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in patient-reported outcomes at 1yr.
Continued controversy exists between cemented versus uncemented hemiarthroplasty for an intracapsular hip fracture. To assist in resolving this controversy, 400 patients were randomised between a cemented polished tapered stem hemiarthroplasty and an uncemented Furlong hydroxyapatite coated hemiarthroplasty. Follow-up was by a nurse blinded to the implant used for up to three years from surgery. Results indicate no difference in the pain scores between implants but a tendency to an improved regain of mobility for those treated with the cemented arthroplasty (1.2 score versus 1.7 at 6 months, p=0.03). There was no difference in early mortality but a tendency to a higher later mortality for the uncemented implants (29% versus 24% at one year, p=0.3). Later peri-prosthetic fracture was more common in the uncemented group (3% versus 1.5%). Revision arthroplasty was required for 2% of cemented cases and 3% of uncemented cases. Surgery for an uncemented hemiarthroplasty was 5 minutes shorter but these patients were more likely to need a blood transfusion (14% versus 7%). Three patients in the cemented group had a major adverse reaction to bone cement leading to their death. These results indicated that a cemented stem hemiarthroplasty give marginally improved regain of mobility in comparison to a contemporary uncemented hemiarthroplasty. An uncemented hemiarthroplasty still has a place for those considered to be at a high risk of bone cement implantation syndrome.
Optimal perioperative fluid management has not been established in patients undergoing orthopaedic surgical procedures. Our purpose was to investigate the effects of perioperative fluid management on patients experiencing TKA. One hundred thirty patients who met inclusion criteria undergoing primary unilateral TKA were prospectively randomized into traditional (TFG) vs. oral (OFG) perioperative fluid management groups. The TFG had a predetermined (4L) amount of intravenous fluids (IVF) administered in the perioperative period. The OFG began drinking a minimum of three, 20-ounces servings of clear fluids daily for three days prior to surgery. This cohort also drank 10-ounces of clear fluids 4 hours prior to surgery. Perioperative IVF were discontinued when the patient began oral intake or when the total amount of IVF reached 500mL. Outcome measures included: body-weight (BW) fluctuations, knee motion, leg girth, bioelectrical impendence, quadriceps activation, functional outcomes testing, KOOS JR, VR-12, laboratory values, vital signs, patient satisfaction, pain scores, and adverse events.Background
Methods
Optimal perioperative fluid management has not been established in patients undergoing orthopaedic surgical procedures. Our purpose was to investigate the effects of perioperative fluid management on patients experiencing TKA. One hundred thirty patients who met inclusion criteria undergoing primary unilateral TKA were prospectively randomized into traditional (TFG) vs. oral (OFG) perioperative fluid management groups. The TFG had a predetermined amount of intravenous fluids (IVF) administered in the perioperative period. The OFG began drinking a minimum of three, 20-ounces servings of clear fluids daily for three days prior to surgery. This cohort also drank 10-ounces of clear fluids 4 hours prior to surgery. Perioperative IVF were discontinued when the patient began oral intake or when the total amount of IVF reached 500mL. Outcome measures included: body-weight (BW) fluctuations, knee motion, leg girth, bioelectrical impendence, quadriceps activation, functional outcomes testing, KOOS JR, VR-12, laboratory values, vital signs, patient satisfaction, pain scores, and adverse events.BACKGROUND
METHODS
A randomized trial was designed to compare the outcome of ceramic-on-ceramic with ceramic on conventional polyethylene. These patients have been followed for 15 years. 58 hips in 57 patients under 60 years of age were randomized into one of two groups. Patients were blinded to the type of hip they received. Both groups of patients were treated routinely with prophylactic peri-operative antibiotics and low molecular weight Heparin. All patients were seen at six weeks, three months and annually after surgery. Clinical and radiologic assessment was carried out at each visit. Fifty-eight hips were available for analysis, 28 in the CoP group and 29 patients in the CoC group. Mean age of both groups was less than 45 years. There were seven revisions (16%) among the 58 patients enrolled in the study. In the CoP group four patients underwent revision with head and liner exchange for eccentric polyethylene wear 16 years post-implantation. In the CoC group one patient had a cup revision at 15 years for acute aseptic instability of the acetabulum; two additional patients in the CoC group had femoral head exchange, one for fracture and one for trunnion corrosion. Both occurred 14 years after the index surgery. Functional outcome scores showed no difference between the two groups at 15 years. Radiographically there was a statistically difference in wear between the two groups. This study demonstrates that both ceramic-on-ceramic and ceramic-on-polyethylene produce satisfactory functional results with low revision rates in young patients.
Functional outcomes of mechanically aligned (MA) total knee arthroplasty have plateaued. The aim of this study is to find an alternative technique for implant positioning that improves functional outcomes of TKA. We prospectively randomized 100 consecutive patients undergoing TKA into two groups: in the group A an intramedullary femoral guide and an extramedullary tibial guide were used with aim to obtain a neutral traditional mechanical alignment; in the group B an extramedullary femoral guide set on distal femoral condyles and an extramedullary tibial guide neutrally aligned were used to obtain an adaptation of the conventional MA technique. Patients were followed-up clinically with the Short Form Health Survey (SF-12), Oxford Knee Score (OKS) and Visual Analogue Score (VAS) questionnaires pre-operatively and then at 1 year post-operatively. Mechanical alignment was calculated on standing weight bearing Xray pre- and post-operatively. T-test was used to compare the results between groups.Introduction
Methods
Greater trochanteric pain syndrome (GTPS) is a common problem affecting 10–25% of the population. Physiotherapy, anti-inflammatories, corticosteroid injections and surgery have all been described in the management of GTPS, all with limited, temporal success. Extracorporeal shockwave therapy (ESWT) has been proposed as a potential management option for this difficult presentation. We ran a prospective, 2 arm, single blinded, randomised control trial comparing focused shockwave therapy to an ultrasound guided corticosteroid injection. The primary outcome measure was the visual analogue pain score. Secondary outcome measures included the Harris hip score and Trendelenburg test for function; the SF-36 for quality of life (QoL); and a Likert scale question for a subjective assessment of symptom improvement.Background
Method
Controlling post-operative pain and reducing opioid requirements after total knee arthroplasty (TKA) remains a challenge, particularly in an era stressing rapid recovery protocols and early discharge. A single shot adductor canal block (ACB) has been shown to be effective in decreasing post-operative pain. This requires a specialty-trained Anesthesiologist skilled in ultrasound techniques, which imposes cost, time and skill barriers. Cadaveric studies and magnetic resonance imaging data have shown that access to the adductor canal is possible from within the joint, and thus the potential for intraoperative, intra-articular, surgeon administered ACB through a standard surgical approach is a feasible alternative to ultrasound guided ACB at the time of TKA. The purpose of the present study is to compare the efficacy of surgeon administered intraoperative ACB to anesthesiologist administered ACB. Patients' undergoing primary TKA were prospectively randomized to receive either an Anesthesiologist administered (Group 1) or Surgeon administered (Group 2) ACB using 15 ml of Ropivacaine 0.5%, both in conjunction with spinal anesthesia. Perioperative multimodal anesthesia was standardized for the two groups. Primary outcomes were pain visual analogue scale (VAS), range of motion, and opioid consumption. Secondary outcomes were patient satisfaction scores and length of stay (LOS).Introduction
Methods
Closed suction intraarticular drain (CSD) use after total knee arthroplasty (TKA) has been studied with regards to wound healing and range of motion, however, no data exist on how CSD use impacts knee joint effusion and quadriceps strength. The primary purpose of this study was to determine whether CSD use influences recovery of quadriceps strength. Secondary outcomes examined effects of CSD on intraarticular effusion, lower limb swelling, knee range of motion (ROM), pain and wound healing complications. Twenty-nine patients undergoing same-day bilateral TKA were enrolled in a prospective, randomized blinded study. Subjects were randomized to receive a CSD on one lower extremity while the contralateral limb had the use of a subcutaneous drain (SCDRN) without the use of suction. Isometric quadriceps strength was collected as the primary outcome. Secondary outcomes consisted of quadriceps muscle activation, intraarticular effusion measured via ultrasound, lower extremity swelling measured with bioelectrical impendence, lower extremity girth, ROM, and pain. Outcomes were assessed preoperatively and postoperatively at day 2, 2 and 6 weeks and 3 months. Differences in limbs were determined using paired t-tests or Wilcoxon signed rank tests.Introduction
Methods
The use of a tourniquet during total knee arthroplasty (TKA) is controversial. Return to function and pain are believed to be affected by the use of a tourniquet. The hypothesis of this study was that use of a tourniquet (T) would delay postoperative functional recovery and increase pain as compared to no tourniquet use (NT). 200 patients were recruited for this prospective, double-blinded, randomized controlled trial. All surgeries were performed by one of two fellowship trained arthroplasty surgeons at our institution. Patients were randomized to either undergo TKA with T or NT and blinded to group allocation. An otherwise standardized perioperative protocol was followed. The primary outcome measures were functional assessment testing using the timed up-and-go (TUG) and stair-climb (SC) tests and visual analog scale pain (VAS-P) scores. Secondary outcome measures included blood loss and range-of-motion (ROM). Patients completed outcomes measures preoperatively, in hospital, and postoperatively at 4–6 weeks and 6–8 months. Minimal detectable change (MDC) and Student's T-test, alpha of p < 0.05, were used to determine significance. No significant differences were seen in postoperative TUG, SC, VAS-P, or ROM at any time point. NT patients were seen to have significantly more calculated blood loss (means: T 1,370.04mL, NT 1,743.85mL; p < 0.001), without a significant increase in transfusion events. Tourniquet use during TKA significantly decreases blood loss and does not adversely affect early postoperative outcomes. Tourniquet use during routine TKA is safe and effective and concerns over deleterious effects on function and pain may not be justified.
Early revision is an important risk factor for repeated revision and poor results after primary total hip replacement and instability is a major cause of early revision. Larger articulations with cross-linked polyethylene are proposed as a solution, but these are not without risk, including fracture of the thin polyethylene rim of the liner. The aim of our study was to examine implant-related revisions among primary total hip replacement patients with up to six year follow-up in a randomized controlled trial which compared 28 mm and 36 mm metal on highly cross-linked polyethylene articulations in total hip replacement. 557 patients undergoing primary total hip replacement were included in this study. Risk factors for dislocation and wear were controlled by stratification and patients were then randomized intra-operatively to either a 28 or 36 mm articulation. To date, 10 hips have been revised for implant-related problems following primary total hip replacement. Seven hips with a 28 mm articulation were revised to a larger articulation because of instability. Four of these were for recurrent dislocation, one for an irreduceable first dislocation and two for subluxation. In contrast, only one patient who had undergone total hip replacement with a 36 mm articulation was revised for recurrent dislocation. One hip with a 36 mm articulation in a well-positioned cup was revised to a 32 mm articulation because of elevated lip liner fracture. Another 36 mm articulation hip was revised for acetabular component loosening. This study shows that a 36 mm metal on highly cross-linked polyethylene articulation reduces the need for early revision for instability after primary total hip replacement. However, these benefits need to be weighed against the potential risks associated with these articulations, including rare fracture of the relatively thin poly-ethylene liner.
We conclude that motivation and other patient related factors, the implant and the surgeon itself influence the result much more than the approach used for total hip replacement.
To decrease haematoma formation, primary soft tissue homeostasis and adequate tissue repair are essential. Growth factors, especially PDGF (platelet derived growth factor) and TGF-β (transforming growth factor-beta), play a crucial role in the biochemical cascade at the site of repair. These growth factors are mostly derived from platelets. The objective of this study was to evaluate the effect of autologous platelet concentrate on blood loss (postoperative decrease of haemoglobin concentration), wound healing complications, range of motion, pain reduction and outcome scores when used in total knee arthroplasty.
The peri-operative haemoglobin concentration, peri-operative range of motion, haematoma formation, number of days of wound drainage and complications were collected. The pain score (VAS), IKSS, 12 questionaire score and SF-36 score were recorded at regular intervals.
Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing total knee arthroplasty (TKA). A variety of highly cross-linked polyethylenes (XLPs) have been introduced to address this problem, but there are few data on the results and complications of this polyethylene in posterior-stabilized knee prosthesis. We have previously reported an interim analysis of a study comparing polyethylene tibial liners. This is a prospective randomized study of one modular posterior-stabilized total knee arthroplasty by a single surgeon. 265 patients (329 knees) were randomized to receive a standard compression molded liner (SP) or a highly cross-linked (6.5 CGy electron-beam irradiated and remelted) polyethylene liner (XLP). Patients were evaluated clinically using the classic Knee Society scores, LEAS score, presence of a knee effusion, and by standard radiographs for radiolucent lines and osteolytic lesions. The analysis was performed at a mean of 6 years (range, 2–11 years).Introduction
Methods
Intraosseous administration of low dose vancomycin has been proven to produce 6 to 20 times higher tissue concentrations compared to intravenous administration in both primary and revision knee replacement. However, these superior levels are achieved when the antibiotic given intraosseously is administered distal to a tourniquet that is inflated for the majority of the case. With increasing interest in limited, or no, tourniquet use during TKA we sought to study the tissue concentrations achieved with limited tourniquet use and intraosseously administered vancomycin compared to weight-based, time optimized intravenous administration. Twenty-four patients undergoing primary TKA were randomized to two groups. The Intravenous (IV) Group received weight based (15mg/kg) vancomycin timed to finish before incision. The Intraosseous (IO) Group received 500 mg of vancomycin injected as a bolus through a needle into the proximal tibia distal to an inflated tourniquet prior to skin incision. In the IO group, the tourniquet was deflated 10 minutes following the injection and re-inflated only for cementation. In the IV group, the tourniquet was only inflated for cementation. During the procedure, fat and bone samples were taken at regular intervals. Tissue antibiotic concentrations were measured using a validated technique involving high performance liquid chromatography.Introduction
Methods
The primary aim of this study was to determine dislocation and revision total hip replacement (THR) up to ten years following primary THR, as well as rates of polyethylene wear, in patients previously enrolled in a randomised controlled trial (RCT) which compared 28 mm and 36 mm metal on highly cross-linked polyethylene (XLPE) articulations. 328 primary THR patients were enrolled in the RCT in Australia. Dislocation was identified from hip instability and hospital visit questionnaires completed by patients or, if they were unable to do so, by their next of kin or primary carer, or General Practitioner. All reported dislocations were confirmed radiographically. Patients' names were cross-matched with the Australian National Joint Replacement Registry to determine whether the index hip had undergone revision THR. Linear wear was measured on plain radiographs using PolyWare (Rev 5, Draftware Developers, Vevay IN, USA). A separate RCT examined the mean proximal wear rate of 28 and 36 mm articulations using radiostereometric analysis (RSA). At 10 years, 110 patients were deceased and 3 patients were lost to follow-up. Overall, dislocation was identified in 8 of 167 (5%) patients with a 28 mm articulation and 2 of 158 (1%) patients with a 36 mm articulation. Three patients experienced recurrent dislocation; all had a 28 mm articulation. 320 (163 28 mm; 157 36 mm) patients were successfully cross-matched with Registry data to identify revision THR. Three patients, all with a 28 mm articulation, underwent revision because of dislocation. Other reasons for revision were infection (1:2), periprosthetic fracture (0:3), loosening/lysis (1:2) and liner fracture (0:1). Adequate radiographs were available to measure wear in 122 hips (67:55) using PolyWare. Excluding bedding in, the mean annual linear wear rate from 1–10 years was 0.04 mm/yr for both 28 and 36 mm articulations (p=0.48). The more sensitive RSA data indicated that at 7 years following primary THR, the mean annual wear rate did not exceed 0.02 mm/yr with either articulation. Up to 10 years following primary THR, 36 mmm articulations were associated with fewer dislocations and revisions for dislocation and did not increase the mean annual linear wear rate.