We compared the chevron and the Wilson metatarsal osteotomy for hallux valgus in a prospective randomised trial on 87 feet in 51 patients, reviewed at averages of 5.5 and 38 months after operation. The patients in the chevron group returned to work earlier and mobilised faster, but, at the later review, those in the Wilson group had better functional results and were more satisfied with the appearance of the foot. Correction of the hallux valgus angle was better maintained in patients in the Wilson group and they had a better range of motion at the metatarsophalangeal joint; fewer complained of metatarsalgia

Aims. The aim of this prospective randomised controlled trial was to compare non-operative and operative management for acute isolated displaced fractures of the olecranon in patients aged ≥ 75 years. Patients and Methods. Patients were randomised to either non-operative management or operative management with either tension-band wiring or fixation with a plate. They were reviewed at six weeks, three and six months and one year after the injury. The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score at one year. Results. A total of 19 patients were randomised to non-operative (n = 8) or operative (n = 11; tension-band wiring (n = 9), plate (n = 2)) management. The trial was stopped prematurely as the rate of complications (nine out of 11, 81.8%) in the operative group was considered to be unacceptable. There was, however, no difference in the mean DASH scores between the groups at all times. The mean score was 23 (0 to 59.6) in the non-operative group and 22 (2.5 to 57.8) in the operative group, one year after the injury (p = 0.763). There was no significant difference between groups in the secondary outcome measures of the Broberg and Morrey Score or the Mayo Elbow Score at any time during the one year following injury (all p ≥ 0.05). . Conclusion. These data further support the role of primary non-operative management of isolated displaced fractures of the olecranon in the elderly. However, the non-inferiority of non-operative management cannot be proved as the trial was stopped prematurely. Cite this article: Bone Joint J 2017;99-B:964–72

Fifty-six patients with displaced malleolar fractures had open reduction and fixation of the fracture fragments using, by random selection, either biodegradable implants or metal AO plates and screws. The cylindrical biodegradable implants were made of polylactide-glycolide copolymer (polyglactin 910). The complications, radiographic results and functional recovery were studied prospectively. After follow-up of at least one year, no significant differences emerged in the complication rate or in the results of treatment between the two methods of fixation. Because of the advantage of avoiding the need to remove metal fixation after union, we now use biodegradable internal fixation routinely to treat displaced malleolar fractures.

We performed a prospective, double-blind, randomised, clinical trial to investigate the efficacy of two regimes of rehabilitation for knees with anterior cruciate ligament deficiency (ACLD). Fifty ACLD patients were randomly allocated to one of two treatment groups: a programme of muscle strengthening (T) or a programme designed to enhance proprioception and improve hamstring contraction reflexes (P). An indirect measure of proprioception, the reflex hamstring contraction latency (RHCL), and a functional scoring system were used to record the status of the knee before and after the 12-week course of physiotherapy. Sagittal knee laxity was also measured. There was improvement in mean RHCL and in the mean functional score in both groups after treatment. The improvement in group P was significantly greater than that in group T. There was no significant change in joint laxity after treatment in either group. In both groups there was a positive correlation between improvement in RHCL and functional gain.

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.

Our aim was to compare polylevolactic acid screws with titanium screws when used for fixation of the distal tibiofibular syndesmosis at mid-term follow-up. A total of 168 patients, with a mean age of 38.5 years (18 to 72) who were randomly allocated to receive either polylevolactic acid (n = 86) or metallic (n = 82) screws were included. The Baird scoring system was used to assess the overall satisfaction and functional recovery post-operatively. The demographic details and characteristics of the injury were similar in the two groups. The mean follow-up was 55.8 months (48 to 66). The Baird scores were similar in the two groups at the final follow-up. Patients in the polylevolactic acid group had a greater mean dorsiflexion (p = 0.011) and plantar-flexion of the injured ankles (p < 0.001). In the same group, 18 patients had a mild and eight patients had a moderate foreign body reaction. In the metallic groups eight had mild and none had a moderate foreign body reaction (p <  0.001). In total, three patients in the polylevolactic acid group and none in the metallic group had heterotopic ossification (p = 0.246).

We conclude that both screws provide adequate fixation and functional recovery, but polylevolactic acid screws are associated with a higher incidence of foreign body reactions.

Cite this article: Bone Joint J 2014;96-B:548–54.

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 performed a randomised prospective trial to compare the results of 27 cemented and 26 uncemented bipolar hemiarthroplasties in active patients with displaced subcapital fractures of the femoral neck. After a mean follow-up of 17 months, significantly more of the uncemented group were experiencing pain in the hip and using more walking aids than the patients in the cemented group. The incidence of postoperative complications, the early mortality rate and the operating time and blood loss were not significantly different. Using otherwise identical prostheses the early results were much better with a cemented Thompson stem than with an uncemented Austin Moore stem

We undertook a prospective randomised controlled trial to investigate the efficacy of autologous retransfusion drains in reducing the need for allogenic blood requirement after unilateral total knee replacement. We also monitored the incidence of post-operative complications. There were 86 patients in the control group, receiving standard care with a vacuum drain, and 92 who received an autologous drain and were retransfused postoperatively. Following serial haemoglobin measurements at 24, 48 and 72 hours, we found no difference in the need for allogenic blood between the two groups (control group 15.1%, retransfusion group 13% (p = 0.439)). The incidence of post-operative complications, such as wound infection, deep-vein thrombosis and chest infection, was also comparable between the groups. There were no adverse reactions associated with the retransfusion of autologous blood. Based on this study, the cost-effectiveness and continued use of autologous drains in total knee replacement should be questioned

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

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.

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.

The aim of this prospective randomised study was to compare the clinical and radiological results of a cemented all-polyethylene Ultima acetabular component with those of a cementless porous-coated acetabular component (PFC) following total hip replacement (THR). A total of 287 patients received either a polyethylene acetabular component (group A) or a cobalt–chromium porous-coated component (group B) with an identical cemented femoral component and 28 mm cobalt-chromium head, thus making it the largest study of its type. Patients were evaluated radiologically and clinically using the Harris hip score (HHS). Group A comprised 183 patients (73 male, 110 female) with a mean age of 71.3 years (55 to 89). Group B comprised 104 patients (48 male, 56 female) with a mean age of 69.8 years (56 to 89). A total of 16 patients (13 in Group A, three in Group B) did not have post-operative data for analysis. The mean follow-up in group A was 7.52 years (0.4 to 15.0) and in Group B 7.87 years (0.5 to 14.0).

At final follow-up the mean HHS was similar between groups A and B (74.5 (25 to 100) and 78.0 (37 to 100), respectively; p = 0.068). The total number of revisions for any cause was 28, 17 of which were in group A and 11 in group B. The ten-year survivorship was 86.8% (95% confidence interval (CI) 78.4 to 92.1) and 89.2% (95% CI 78.3 to 94.8) for groups A and B, respectively (log-rank p-value = 0.938). A total of 20 cemented and two cementless acetabular components had evidence of acetabular radiolucencies or acetabular component migration at last follow-up (p = 0.001).

These results indicate that patients with a cemented all-polyethylene and cementless porous-coated polyethylene lined acetabular component have similar long-term clinical outcomes.

In a prospective randomised trial of calcifying tendinitis of the rotator cuff, we compared the efficacy of dual treatment sessions delivering 2500 extracorporeal shock waves at either high- or low-energy, via an electromagnetic generator under fluoroscopic guidance. Patients were eligible for the study if they had more than a three-month history of calcifying tendinitis of the rotator cuff, with calcification measuring 10 mm or more in maximum dimension. The primary outcome measure was the change in the Constant and Murley Score. A total of 80 patients were enrolled (40 in each group), and were re-evaluated at a mean of 110 (41 to 255) days after treatment when the increase in Constant and Murley score was significantly greater (t-test, p = 0.026) in the high-energy treatment group than in the low-energy group. The improvement from the baseline level was significant in the high-energy group, with a mean gain of 12.5 (−20.7 to 47.5) points (p < 0.0001). The improvement was not significant in the low-energy group. Total or subtotal resorption of the calcification occurred in six patients (15%) in the high-energy group and in two patients (5%) in the low-energy group. High-energy shock-wave therapy significantly improves symptoms in refractory calcifying tendinitis of the shoulder after three months of follow-up, but the calcific deposit remains unchanged in size in the majority of patients

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

We have compared the results of simple patellectomy (group A, n = 16) and patellectomy with advancement of the vastus medialis obliquus (group B, n = 12) in a prospective, randomised trial, with a minimum follow-up of three years. The results in group B were significantly better (p < 0.001) than those in group A. Although the patella should be preserved if possible, we advocate advancement of the vastus medialis obliquus when patellectomy is necessary

We report a prospective randomised trial comparing Keller's arthroplasty and arthrodesis of the first metatarsophalangeal joint for the management of symptomatic hallux valgus and hallux rigidus in the older patient. In 81 patients (110 feet), with a minimum of two years follow-up, both procedures gave a similar degree of patient satisfaction and symptom relief. The incidence of metatarsalgia was also similar. As there were no obvious advantages to arthrodesis, and since six out of 50 arthrodesed toes required revision, we suggest that Keller's arthroplasty is the better operation in these patients

Aims. This is a prospective randomised controlled trial comparing the functional outcomes of plate fixation and elastic stable intramedullary nailing (ESIN) of completely displaced mid-shaft fractures of the clavicle in the active adult population. Patients and Methods. We prospectively recruited 123 patients and randomised them to either plate fixation or ESIN. Patients completed the Quick Disabilities of the Arm, Shoulder and Hand (DASH) score at one to six weeks post-operatively. They were followed up at six weeks, three and six months and one year with radiographs, and their clinical outcome was assessed using both the DASH and the Constant Score. Results. Plate fixation provided a faster functional recovery during the first six months compared with ESIN, but there was no difference after one year. The duration of surgery was shorter for ESIN (mean 53.4 minutes, 22 to 120) than for plate fixation (mean 69.7 minutes, 35 to 106, p < 0.001). The recovery after ESIN was slower with increasing fracture comminution and with open reduction (p < 0.05). Conclusion. Both methods return the patients to their pre-injury functional levels, but plate fixation has a faster recovery period in comminuted fractures than ESIN. ESIN has a shorter operative time and lower infection and implant rates of failure when using 2.5 mm nails or wider, suggesting that this is the preferred method in mid-shaft fractures with no comminution, whereas plate fixation is the superior method in comminuted fractures. Cite this article: Bone Joint J 2017;99-B:1095–1101