We performed a randomised trial on 37 hips (33 patients) with early-stage osteonecrosis (ON). After the initial clinical evaluation, including plain radiography and MRI, 18 hips were randomly assigned to a core-decompression group and 19 to a conservatively-treated group. All the patients were regularly followed up by clinical evaluation, plain radiography and MRI at intervals of three months. Hip pain was relieved in nine out of ten initially symptomatic hips in the core-decompression group but persisted in three out of four initially painful hips in the conservatively-treated group at the second assessment (p < 0.05). At a minimum follow-up of 24 months, 14 of the 18 core-decompressed hips (78%) and 15 of the 19 non-operated hips (79%) developed collapse of the femoral head. By survival analysis, there was no significant difference in the time to collapse between the two groups (log-rank test p = 0.79). Core decompression may be effective tin symptomatic relief, but is of no greater value than conservative management in preventing collapse in early osteonecrosis of the femoral head

We compared the outcome of closed intramedullary nailing with minimally invasive plate osteosynthesis using a percutaneous locked compression plate in patients with a distal metaphyseal fracture in a prospective study. A total of 85 patients were randomised to operative stabilisation either by a closed intramedullary nail (44) or by minimally invasive osteosynthesis with a compression plate (41). Pre-operative variables included the patients’ age and the side and pattern of the fracture. Peri-operative variables were the operating time and the radiation time. Postoperative variables were wound problems, the time to union of the fracture, the functional American Orthopaedic Foot and Ankle surgery score and removal of hardware. We found no significant difference in the pre-operative variables or in the time to union in the two groups. However, the mean radiation time and operating time were significantly longer in the locked compression plate group (3.0 vs 2.12 minutes, p < 0.001, and 97.9 vs 81.2 minutes, p < 0.001, respectively). After one year, all the fractures had united. Patients who had intramedullary nailing had a higher mean pain score, but better function, alignment and total American Orthopaedic Foot and Ankle surgery scores, although the differences were not statistically significant (p = 0.234, p = 0.157, p = 0.897, p = 0.177 respectively). Three (6.8%) patients in the intramedullary nailing group and six (14.6%) in the locked compression plate group showed delayed wound healing, and 37 (84.1%) in the former group and 38 (92.7%) in the latter group expressed a wish to have the implant removed. We conclude that both closed intramedullary nailing and a percutaneous locked compression plate can be used safely to treat Orthopaedic Trauma Association type-43A distal metaphyseal fractures of the tibia. However, closed intramedullary nailing has the advantage of a shorter operating and radiation time and easier removal of the implant. We therefore prefer closed intramedullary nailing for patients with these fractures

We undertook a prospective, randomised study of 135 total knee arthroplasties to determine the most accurate and reliable technique for alignment of the tibial prosthesis. Tibial resection was guided by either intramedullary or extramedullary alignment jigs. Of the 135 knees, standardised postoperative radiographs suitable for assessment were available in 100. Correct tibial alignment was found in 85% of the intramedullary group compared with 65% of the extramedullary group (p = 0.019). We conclude that intramedullary guides are superior to extramedullary instruments for alignment of the tibial prosthesis

We performed a prospective randomised trial on matched groups of patients with displaced tibial shaft fractures to compare conservative treatment with closed intramedullary nailing. The results showed conclusively that intramedullary nailing gave more rapid union with less malunion and shortening. Nailed patients had less time off work with a more predictable and rapid return to full function. We therefore consider that closed intramedullary nailing is the most efficient treatment for displaced fractures of the tibial shaft

Exposure to blood is a hazard for all surgeons. We assessed the incidence of glove perforation and needlestick injury from a new blunt taperpoint needle designed to penetrate tissues other than skin with the minimum of force. We performed a prospective, randomised trial comparing the incidence of perforations of surgical gloves with the new needle and a standard cutting needle during wound closure after hip arthroplasties. There was at least one glove perforation in 46 of 69 such procedures (67%). The use of the taperpoint needle produced a significant decrease in perforations (p = 0.049)

A randomised double-blind study was carried out on 60 patients undergoing elective lumbar discectomy. Patients in the study group (n = 30) received an injection of 10 ml of 0.5% bupivacaine into the wound; the control group (n = 30) received none. Postoperative pain was measured by a visual analogue pain scale and by the amount of morphine administered by a patient-controlled analgesia system. Patients in the study group had lower pain scores, used less morphine, waited longer until their first demand for analgesia and reported their postoperative pain to be less severe

Modifications in the design of knee replacements have been proposed in order to maximise flexion. We performed a prospective double-blind randomised controlled trial to compare the functional outcome, including maximum knee flexion, in patients receiving either a standard or a high flexion version of the NexGen legacy posterior stabilised total knee replacement. A total of 56 patients, half of whom received each design, were assessed pre-operatively and at one year after operation using knee scores and analysis of range of movement using electrogoniometry. For both implant designs there was a significant improvement in the function component of the knee scores (p < 0.001) and the maximum range of flexion when walking on the level, ascending and descending a slope or stairs (all p < 0.001), squatting (p = 0.020) and stepping into a bath (p = 0.024). There was no significant difference in outcome, including the maximum knee flexion, between patients receiving the standard and high flexion designs of this implant

We report the results of a prospective randomised controlled trial of the management of 101 Colles' fractures in patients over the age of 55 years. Within two weeks of initial reduction 43 fractures had displaced with either more than 10 degrees dorsal angulation or more than 5 mm radial shortening. These patients were randomly divided into two groups: 21 were remanipulated and held by an external fixator; in the control group of 22 patients, the redisplacement was accepted and conservative treatment was continued. Patients treated with external fixation had a good anatomical result, but their function was no better than that of the control group. We found no correlation between final anatomical and functional outcome, and concluded that the severity of the original soft-tissue injury and its complications are the major determinants of functional end result

It remains a matter of debate whether displaced fractures of the neck of the femur should be treated by internal fixation or arthroplasty. We have compared the two methods with regard to complications, mortality and functional outcome. We studied 409 patients, aged 70 years and over, with subcapital fractures graded as Garden 3 or 4, in a two-year prospective multicentre study from 12 Swedish hospitals. They were randomised to internal fixation or arthroplasty. Patients who were mentally confused, bedridden or in a nursing-home were excluded from the survey. After two years the rate of failure was 43% in the internal fixation (IF) and 6% in the arthroplasty group (p < 0.001). In the IF group 36% had impaired walking and 6% had severe pain compared with 25% and 1.5%, respectively, in the arthroplasty group (both p < 0.05). There was no difference in mortality. With a high rate of failure and poor functional outcome after IF, we recommend primary arthroplasty for displaced fractures of the neck of the femur in patients over 70 years of age

In a double-blind, randomised, prospective study of 139 patients undergoing arthroscopic meniscectomy, those receiving a prostaglandin inhibitor (naproxen sodium) had significantly less pain, less synovitis and less effusion. They had significantly more rapid return of movement and of quadriceps function; their return to work and to sport also was significantly faster. It is recommended that, provided there are no contraindications, a prostaglandin inhibitor should be used after arthroscopic procedures

We report a prospective, randomised, controlled trial of the effect of either a non-steroidal anti-inflammatory drug (diclofenac sodium) or physiotherapy on the recovery of knee function after arthroscopy. At 42 days after surgery there was no significant benefit from either form of postoperative treatment compared with the control group. Complications attributable to the anti-inflammatory drug occurred in 9.6% of the patients so treated. Neither the routine administration of a non-steroidal anti-inflammatory agent nor routine physiotherapy is justified after arthroscopy of the knee

We undertook a prospective, randomised study to compare the analgesic effect of injection of steroid and of extracorporeal shock-wave therapy (ESWT) for the treatment of tennis elbow. Group 1 received a single injection of 20 mg of triamcinolone with lignocaine while group 2 received 2000 shock waves in three sessions at weekly intervals. After six weeks there was a significant difference between the groups with the mean pain score for the injection group falling from 66 to 21 compared with a decrease from 61 to 35 in the shock-wave group (p = 0.05). After three months, 84% of patients in group 1 were considered to have had successful treatment compared with 60% in group 2. In the medium term local injection of steroid is more successful and 100 times less expensive than ESWT in the treatment of tennis elbow

All elderly patients with extracapsular hip fractures seen in hospitals in Newcastle upon Tyne over a 12-month period were studied and followed up for six months. At one of the hospitals, patients were randomised to treatment by AO dynamic hip-screw or by traction. Complications specific to the two treatments were low, and general complications, six-month mortality and prevalence of pain, leg swelling and unhealed sores, showed no difference between the two modes of treatment. Operative treatment gave better anatomical results and a shorter hospital stay, but significantly more of the patients treated by traction showed loss of independence six months after injury

Patients who undergo total knee replacement (TKR)are at high risk of venous thromboembolism. Low-molecular-weight heparins (LMWH) are the most suitable chemical prophylactic agents but there are some uncertainties about their safety and effectiveness. The foot pump offers an alternative. We randomised 229 patients undergoing primary, unilateral TKR to receive either the A-V Impulse foot pump or enoxaparin, a LMWH. Ascending venography was undertaken between the sixth and eighth postoperative day in 188 patients without knowledge of the randomisation category. The prevalence of venographic deep-vein thrombosis was 58% (57/99) in the foot-pump group and 54% (48/89) in the LMWH group which was not statistically significant. There were four cases of proximal thrombi and two of fatal pulmonary emboli in the foot-pump group and none in the LMWH group. There were fewer haemorrhagic complications and soft-tissue effects in the foot-pump group. We conclude that the neither method provides superior prophylaxis

A prospective randomised trial of surgical treatment for the displaced subcapital femoral fracture in patients of 70 years or more is presented. Two hundred and eighteen patients were randomly allocated into one of three treatment groups: manipulative reduction and internal fixation using Garden screws; Thompson hemiarthroplasty through a posterior (Moore) approach; and Thompson hemiarthroplasty through an anterolateral (McKee) approach. There is no significant difference in the mortality of the internal fixation and posterior arthroplasty groups. Both groups showed a significantly higher mortality than patients operated on through the anterior approach. The technical results of operation were worse in the internally fixed group, with only 40 per cent being satisfactory. Mobilisation was best achieved after the posterior approach. It is concluded that Thompson hemiarthroplasty, using an anterolateral approach, is the safest operation in this group of patients

Aims

Our purpose was to determine the quality of current randomised controlled trials (RCTs) in hand surgery using standardised metrics.

We conducted a prospective randomised trial to compare the results of anatomical reduction and medial displacement osteotomy in 127 consecutive patients with unstable intertrochanteric fractures, of whom 109 completed the study. After an average follow-up of 11 months, we found no significant differences in walking ability, social status or failure of fixation in the two groups. Postoperative complication rates and the early mortality rate were not significantly different, but operating time and blood loss were significantly higher in the osteotomy group. With the use of modern sliding hip screws, medial displacement osteotomy is rarely indicated for unstable intertrochanteric fractures

In a randomised prospective trial 98 elderly women with trochanteric fractures of the femur were treated with either a 135 degrees Jewett nail-plate or a 135 degrees Dynamic hip screw. The results at six weeks, three months and six months were statistically analysed. There were no significant differences in the two groups with regard to pain, length of hospital stay, morbidity or mortality. Although operative difficulties and open reduction were more common with the Dynamic hip screw, at the end of six months more patients in this group were mobile and there was significant radiological evidence of better compression without loss of fixation

Multicentre clinical trials in trauma care are gaining prominence as a means of generating good-quality evidence to inform and influence clinical practice. We believe multicentre trials have an important role to play in supporting evidence-based practice, and further investment in such trials is justified.

The Gamma nail was introduced for the treatment of peritrochanteric fractures with the theoretical advantage of a load-sharing femoral component which could be implanted by a closed procedure. We report a randomised prospective study of 186 fractures treated by either the Gamma nail or a dynamic hip screw. Gamma nails were implanted with significantly shorter screening times, smaller incisions, and less intraoperative bleeding. The Gamma nail group had a shorter convalescence and earlier full weight-bearing, but there was no significant difference in mortality within six months, postoperative mobility, or hip function at review. More intra-operative complications were recorded in the Gamma nail group, mainly due to the mismatching of the femoral component of the nail to the small femurs of Chinese people. Use of a smaller modified nail reduced these complications. We conclude that with careful surgical technique and the modified femoral component, the Gamma nail is an advance in the treatment of peritrochanteric fractures