Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.

We have analysed the management and clinical outcome of a series of consecutive patients who had a total hip replacement and developed post-operative surgical site infection (SSI) with methicillin-resistant Staphylococcus aureus. The incidence of this infection was 1% over a period of five years. We studied SSI in 15 patients (16 infections) with a mean age of 72.7 years (53 to 81). In all, 12 of the infections occurred early and half of the infections involved the prosthesis, resulting in an increase of 11-fold in the cumulative hospital stay.

Methicillin-resistant Staph. aureus was successfully eradicated in all the patients after a mean follow-up of 53.6 months (25 to 88). Superficial incisional infections resolved after antibiotic therapy alone while deep infections required multiple operative debridements. Attempted retention of the implant in early organ space infections was successful in only one of five patients. Only three patients with implant-level infections obtained a pain-free, functional prosthesis while a further three required excision arthroplasty. We have formulated a protocol of treatment which may serve as a guide in the management of these infections.

We describe a technique of ‘cross-hip distraction’ to reduce a dislocated hip with subsequent reconstruction of the joint for septic arthritis with extensive femoral osteomyelitis. A 27-year-old woman presented with a dislocated, collapsed femoral head and chronic osteomyelitis of the femur. Examination revealed a leg-length discrepancy of 7 cm and an irritable hip. A staged technique was used with primary clearance of osteomyelitis and secondary reconstruction of the hip. A cross-hip monolateral external fixator was used to establish normal anatomy followed by an arthroplasty. A good functional outcome was achieved. The use of cross-hip distraction avoids soft-tissue and nerve damage and achieved improved abductor function before arthroplasty.

We retrospectively reviewed 175 patients (191 hips) who had undergone primary cemented total hip replacement between November 1992 and November 1995 using a collarless polished double-tapered femoral component after a minimum of ten years (mean 11.08; 10 to 12.8). All stems were implanted using contemporary cementing techniques with a distal cement restrictor, pressurised lavage, retrograde cementing with a gun and proximal pressurisation. Clinical outcome was assessed using the Harris Hip score. Radiological analysis was performed on calibrated plain radiographs taken in two planes. Complete radiological data on 110 patients (120 hips) and clinical follow-up on all the surviving 111 patients (122 hips) was available. The fate of all the hips was known.

At final follow-up, the mean Harris Hip score was 86 (47 to 100), and 87 of 116 patients (75%) had good or excellent scores. Survival with revision of the stem for aseptic loosening as the endpoint was 100%; and survival with revision of the stem for any reason was 95.9% (95% confidence interval 87.8 to 96.8) at ten years. All the stems subsided vertically at the stem-cement interface in a predictable pattern, at an overall mean rate of 0.18 mm per year (0.02 to 2.16), but with a mean rate of 0.80 mm (0.02 to 2.5) during the first year. The mean total subsidence was 1.95 mm (0.21 to 24). Only three stems loosened at the cement-bone interface. There was excellent preservation of proximal femoral bone stock. There was a high incidence of Brooker III and IV heterotopic ossification affecting 25 patients (22%).

The collarless polished tapered stem has an excellent clinical and radiological outcome at a minimum of ten years’ follow-up. The pattern and magnitude of subsidence of the stem within the cement mantle occurred in a predictable pattern, consistent with the design philosophy.

We evaluated the long-term fixation of 64 press-fit cemented stems of constrained total knee prostheses in 32 young patients with primary malignant bone tumours. Initial stable fixation, especially in rotation, was achieved by precise fit of the stem into the reamed endosteum, before cementation. Complementary fixation, especially in migration and rotation, was obtained by pressurised antibiotic-loaded cement. The mean age at operation was 33 years (13 to 61). No patient was lost to follow-up; 13 patients died and the 19 survivors were examined at a mean follow-up of 12.5 years (4 to 21). Standard revision press-fit cemented stems were used on the side of the joint which was not involved with tumour (26 tibial and six femoral), on this side there was no loosening or osteolysis and stem survival was 100%. On the reconstruction side, custom-made press-fit stems were used and the survival rate, with any cause for revision as an end point, was 88%, but 97% for loosening or osteolysis. This longevity is similar to that achieved at 20 years with the Charnley-Kerboull primary total hip replacement with press-fit cemented femoral components.

We recommend this type of fixation when extensive reconstruction of the knee is required. It may also be suitable for older patients requiring revision of a total knee replacement or in difficult situations such as severe deformity and complex articular fractures.

We reviewed the results of 71 revisions of the acetabular component in total hip replacement, using impaction of bone allograft. The mean follow-up was 7.2 years (1.6 to 9.7). All patients were assessed according to the American Academy of Orthopedic Surgeons (AAOS) classification of bone loss, the amount of bone graft required, thickness of the graft layer, signs of graft incorporation and use of augmentation.

A total of 20 acetabular components required re-revision for aseptic loosening, giving an overall survival of 72% (95% CI, 54.4 to 80.5). Of these failures, 14 (70%) had an AAOS type III or IV bone defect. In the failed group, poor radiological and histological graft incorporation was seen.

These results suggest that impaction allografting in acetabular revision with severe bone defects may have poorer results than have previously been reported.

We investigated whether improvements in design have altered the outcome for patients undergoing endoprosthetic replacement of the distal femur after resection of a tumour. Survival of the implant and ‘servicing’ procedures have been documented using a prospective database, review of the design of the implant and case records. In total, 335 patients underwent a distal femoral replacement, 162 having a fixed-hinge design and 173 a rotating-hinge. The median age of the patients was 24 years (interquartile range 17 to 48).

A total of 192 patients remained alive with a mean follow-up of 12 years (5 to 30). The risk of revision for any reason was 17% at five years, 33% at ten years and 58% at 20 years. Aseptic loosening was the main reason for revision of the fixed-hinge knees while infection and fracture of the stem were the most common for the rotating-hinge implant. The risk of revision for aseptic loosening was 35% at ten years with the fixed-hinge knee, which has, however, been replaced by the rotating-hinge knee with a hydroxyapatite collar. The overall risk of revision for any reason fell by 52% when the rotating-hinge implant was used.

Improvements in the design of distal femoral endoprostheses have significantly decreased the need for revision operations, but infection remains a serious problem. We believe that a cemented, rotating-hinge prosthesis with a hydroxyapatite collar offers the best chance of long-term survival of the prosthesis.

We compared the performance of uncemented trabecular metal tibial components in total knee replacement with that of cemented tibial components in patients younger than 60 years over two years using radiostereophotogrammetric analysis (RSA). A total of 22 consecutive patients (mean age 53 years, 33 to 59, 26 knees) received an uncemented NexGen trabecular metal cruciate-retaining monobloc tibial component and 19 (mean 53 years, 44 to 59, 21 knees) a cemented NexGen Option cruciate-retaining modular tibial component.

All the trabecular metal components migrated during the initial three months and then stabilised. The exception was external rotation, which did not stabilise until 12 months. Unlike conventional metal-backed implants which displayed a tilting migration comprising subsidence and lift-off from the tibial tray, most of the trabecular metal components showed subsidence only, probably due to the elasticity of the implant.

This pattern of subsidence is regarded as being beneficial for uncemented fixation.

This study reviews the predisposing features, the clinical, and laboratory findings at the time of diagnosis and the results of single-stage revision of prosthetic replacement of the elbow for infection.

Deep infection occurred in six of 305 (1.9%) primary total elbow replacements. The mean follow-up after revision was 6.8 years (6 months to 16 years) and the mean age at the time of revision was 62.7 years (56 to 74). All six cases with infection had rheumatoid arthritis and had received steroid therapy. The infective organism was Staphylococcus aureus. Four of the six elbows had a developed radiolucency around one component or the other. Successful single-stage exchange arthroplasty was carried out with antibiotic-loaded cement in five of the six cases. In one, the revision prosthesis had to be removed following recurrence of the infection. The functional result was good in three elbows, fair in one, poor in one and fair in the resection arthroplasty.

A combination of hemivertebrae and diastematomyelia is rare. We have identified 12 such patients seen during a period of 11 years in the orthopaedic, spinal and neurosurgical units in Nottingham and analysed their treatment and outcome.

This prospective study evaluates the role of new laboratory markers in the diagnosis of deep implant infection in 78 patients (41 men and 37 women) with a revision total knee or hip replacement.

The mean age at the time of operation was 64.0 years (19 to 90). Intra-operative cultures showed that 21 patients had a septic and 57 an aseptic total joint replacement. The white blood cell count, the erythrocyte sedimentation rate and levels of C-reactive protein, interleukin-6, procalcitonin and tumour necrosis factor (TNF)-α were measured in blood samples before operation. The diagnostic cut-off values were determined by Received Operating Characteristic curve analysis.

C-reactive protein (> 3.2 md/dl) and interleukin-6 (> 12 pg/ml) have the highest sensitivity (0.95). Interleukin-6 is less specific than C-reactive protein (0.87 vs 0.96). Combining C-reactive protein and interleukin-6 identifies all patients with deep infection of the implant. Procalcitonin (> 0.3 ng/ml) and TNF-α (> 40 ng/ml) are very specific (0.98 vs 0.94) but have a low sensitivity (0.33 vs 0.43).

The combination of C-reactive protein and interleukin-6 measurement provide excellent screening tests for infection of a deep implant. A highly specific marker such as procalcitonin and pre-operative aspiration of the joint might be useful in identifying patients with true positive C-reactive protein and/or interleukin-6 levels.

We evaluated the use of a stemmed acetabular component in the treatment of severe acetabular deficiency during revision and complex primary total hip arthroplasty.

There were 31 hips of which 24 were revisions (20 for aseptic loosening, four for infection) and the remainder were complex primary arthroplasties. At a mean follow-up of 10.7 years (6 to 12.8), no component had been revised for aseptic loosening; one patient had undergone a revision of the polyethylene liner for wear. There was one failure because of infection. At the latest follow-up, the cumulative survival rate for aseptic loosening, with revision being the end-point, was 100%; for radiographic loosening it was 92% and for infection and radiographic loosening it was 88%. These results justify the continued use of this stemmed component for the reconstruction of severe acetabular deficiency.

We assessed the outcome of patients with Vancouver type B2 and B3 periprosthetic fractures treated with femoral revision using an uncemented extensively porous-coated implant. A retrospective clinical and radiographic assessment of 22 patients with a mean follow-up of 33.7 months was performed. The mean time from the index procedure to fracture was 10.8 years. There were 17 patients with a satisfactory result. Complications in four patients included subsidence in two, deep sepsis in one, and delayed union in one. Concomitant acetabular revision was required in 19 patients. Uncemented extensively porous-coated femoral stems incorporate distally allowing stable fixation. We found good early survival rates and a low incidence of nonunion using this implant.

A modular layered acetabular component (metal-polyethylene-ceramic) was developed in Japan for use in alumina ceramic-on-ceramic total hip replacement. Between May 1999 and July 2000, we performed 35 alumina ceramic-on-ceramic total hip replacements in 30 consecutive patients, using this layered component and evaluated the clinical and radiological results over a mean follow-up of 5.8 years (5 to 6.5). A total of six hips underwent revision, one for infection, two for dislocation with loosening of the acetabular component, two for alumina liner fractures and one for component dissociation with pelvic osteolysis. There were no fractures of the ceramic heads, and no loosening of the femoral or acetabular component in the unrevised hips was seen at final follow-up. Osteolysis was not observed in any of the unrevised hips. The survivorship analysis at six years after surgery was 83%. The layered acetabular component in our experience, has poor durability because of unexpected mechanical failures including alumina liner fracture and component dissociation.

The routine use of surgical drains in total hip arthroplasty remains controversial. They have not been shown to decrease the rate of wound infection significantly and can provide a retrograde route for it. Their use does not reduce the size or incidence of post-operative wound haematomas. This prospective, randomised study was designed to evaluate the role of drains in routine total hip arthroplasty.

We investigated 552 patients (577 hips) undergoing unilateral or bilateral total hip arthroplasty who had been randomised to either having a drain for 24 hours or not having a drain. All patients followed standardised pre-, intra-, and post-operative regimes and were independently assessed using the Harris hip score before operation and at six, 18 and 36 months follow-up.

The rate of superficial and deep infection was 2.9% and 0.4%, respectively, in the drained group and 4.8% and 0.7%, respectively in the undrained group. One patient in the undrained group had a haematoma which did not require drainage or transfusion. The rate of transfusion after operation in the drained group was significantly higher than for undrained procedures (p < 0.042). The use of a drain did not influence the post-operative levels of haemoglobin, the revision rates, Harris hip scores, the length of hospital stay or the incidence of thromboembolism. We conclude that drains provide no clear advantage at total hip arthroplasty, represent an additional cost, and expose patients to a higher risk of transfusion.

We investigated 219 revisions of total hip replacement (THR) in 211 patients using a collarless double-taper cemented femoral component. The mean age of the patients was 72 years (30 to 90). The 137 long and 82 standard length stems were analysed separately. The mean follow-up was six years (2 to 18), and no patient was lost to follow-up.

Survival of the long stems to re-revision for aseptic loosening at nine years was 98% (95% confidence interval (CI) 94 to 100), and for the standard stems was 93% (95% CI 85 to 100). At five years, one long stem was definitely loose radiologically and one standard stem was probably loose. Pre-operative femoral bone deficiency did not influence the results for the long stems, and corrective femoral osteotomy was avoided, as were significant subsidence, major stress shielding and persistent thigh pain.

Because of these reliable results, cemented long collarless double-taper femoral components are recommended for routine revision THR in older patients.

We compared six patients with a mean age of 70 years (49 to 80) with severe bilateral, painful glenohumeral joint destruction who underwent a single-stage bilateral total shoulder replacement, with eight patients of mean age 61 years (22 to 89) who underwent bilateral total shoulder replacement in two stages, at a mean interval of 18 months (6 to 43).

The overall function, pain and strength improved significantly in both groups. The subjective shoulder value, relative Constant score, active external rotation and the strength were improved significantly more in the single-stage group. Active elevation, abduction and overall function improved, significantly more in the single-stage group. Both the total duration of hospitalisation and the time off work per shoulder were substantially shorter in the single-stage group. The overall rate of complication was lower in the single-stage group.

Our findings indicated that single-stage bilateral total shoulder replacement yielded significantly better clinical results with shorter hospitalisation and rehabilitation than staged replacement, and was not associated with any increase in complications.

Autologous chondrocyte implantation (ACI) has been used most commonly as a treatment for cartilage defects in the knee and there are few studies of its use in other joints. We describe ten patients with an osteochondral lesion of the talus who underwent ACI using cartilage taken from the knee and were prospectively reviewed with a mean follow-up of 23 months. In nine patients the satisfaction score was ‘pleased’ or ‘extremely pleased’, which was sustained at four years. The mean Mazur ankle score increased by 23 points at a mean follow-up of 23 months. The Lysholm knee score returned to the pre-operative level at one year in three patients, with the remaining seven showing a reduction of 15% at 12 months, suggesting donor-site morbidity. Nine patients underwent arthroscopic examination at one year and all were shown to have filled defects and stable cartilage. Biopsies taken from graft sites showed mostly fibrocartilage with some hyaline cartilage. The short-term results of ACI for osteochondral lesions of the talus are good despite some morbidity at the donor site.

We have examined the differences in clinical outcome of total knee replacement (TKR) with and without patellar resurfacing in a prospective, randomised study of 181 osteoarthritic knees in 142 patients using the Profix total knee system which has a femoral component with features considered to be anatomical and a domed patellar implant.

The procedures were carried out between February 1998 and November 2002. A total of 159 TKRs in 142 patients were available for review at a mean of four years (3 to 7). The patients and the clinical evaluator were blinded in this prospective study. Evaluation was undertaken annually by an independent observer using the knee pain scale and the Knee Society clinical rating system. Specific evaluation of anterior knee pain, stair-climbing and rising from a seated to a standing position was also undertaken.

No benefit was shown of TKR with patellar resurfacing over that without resurfacing with respect to any of the measured outcomes. In 22 of 73 knees (30.1%) with and 18 of 86 knees (20.9%) without patellar resurfacing there was some degree of anterior knee pain (p = 0.183). No revisions related to the patellofemoral joint were performed in either group. Only one TKR in each group underwent a re-operation related to the patellofemoral joint. A significant association between knee flexion contracture and anterior knee pain was observed in those knees with patellar resurfacing (p = 0.006).

We treated 34 patients with recurrent dislocation of the hip with a constrained acetabular component. Roentgen stereophotogrammetric analysis was performed to assess migration of the prosthesis.

The mean clinical follow-up was 3.0 years (2.2 to 4.8) and the radiological follow-up was 2.7 years (2.0 to 4.8). At the latest review six patients had died and none was lost to follow-up. There were four acetabular revisions, three for aseptic loosening and one for deep infection. Another acetabular component was radiologically loose with progressive radiolucent lines in all Gruen zones and was awaiting revision. The overall rate of aseptic loosening was 11.8% (4 of 34). Roentgen stereophotogrammetric analysis in the non-revised components confirmed migration of up to 1.06 mm of translation and 2.32° of rotation at 24 months. There was one case of dislocation and dissociation of the component in the same patient. Of the 34 patients, 33 (97.1%) had no further episodes of dislocation.

The constrained acetabular component reported in our study was effective in all but one patient with instability of the hip, but the rate of aseptic loosening was higher than has been reported previously and requires further investigation.