Background: While surgical trials can rarely blind surgeons or patients, they can often blind outcome assessors. The aim of this systematic review was threefold:

1) to examine the reporting of outcome measures in orthopaedic trials,

Specifically, we focused on an association between blinding of outcome assessment and the size of the reported treatment effect; in other words: does blinding of outcome assessors matter?

Methods: We reviewed 32 identified RCTs published in the Journal of Bone and Joint Surgery (American Volume), in 2003 and 2004 for the appropriate use of outcome measures. These RCTs represented 3.4% (32/938) of all studies published during that time period. All RCTs were reviewed by two of us for:

1) the outcome measures used and

We calculated the magnitude of treatment effect of blinded compared to un-blinded outcome assessors.

Results: The methodological validation and clinical usefulness of the clinician-based, patient-based, and generic outcome instruments varied. Ten of the 32 RCTs (31%) used a modified outcome instrument. Of these 10 trials, 4 (40%) failed to describe how the outcome instrument was modified. Nine (90%) of the 10 articles did not describe how their modified instrument was validated and retested. Sixteen (50%) of the 32 RCTs did not report blinding of outcome assessors where blinding would have been possible. Among those studies with continuous outcome measure, unblinded outcomes assessment was associated with significantly larger treatment effects (standardized mean difference 0.76 versus 0.25, p=0.01). Similarly, in those studies with dichotomous outcomes, unblinded outcomes assessments were associated with significantly greater treatment effects (Odds ratio 0.13 versus 0.42, unblinded versus blinded, p< 0.001). The ratio of odds ratios (unblinded to blinded) was 0.31 suggesting that unblinded outcomes assessment was associated with an exaggeration of the benefit of a treatment’s effectiveness in our cohort of studies.

Conclusion: Reported outcomes in RCTs are often modified and rarely validated. Half of the RCTs did not blind outcome assessors even though blinding of outcome assessors would have been feasible in each case. Treatment effects may be exaggerated if outcome assessors are unblinded. Emphasis should be placed on detailed reporting of outcome measures to facilitate generalization. Outcome assessors should be blinded where possible to prevent bias.

We have analysedin the results of 24 femoral lengthenings in 23 patients operated on between 1993 and 2000, using a gradual elongation intramedullary nail (Albizzia). Of the 23 patients, 22 had femoral deficiency and one was of short stature. Their mean age was 16.9 years. Technical difficulties encountered during the procedure were mild or moderate in 18 femora and severe in six femora. Distraction was obtained by 15 ratchetings per day (1 mm/day).

There were 18 excellent results although in two patients this was achieved after the development of a pseudarthrosis which required further surgery. There were four good and two fair results in which the lengthening obtained was at least 3 cm less than had been projected. The consolidation index was 35.2 days/cm. No patient had associated long-term stiffness of the knee.

Femoral lengthening using an elongation nail gives good results and is a comfortable procedure.

Dysplastic acetabula were augmented during total hip replacement by superolateral autografts. In cases of primary arthroplasty these were taken from the excised femoral head and in revision surgery from the iliac crest. Two or (usually) three small grafts were used to facilitate revascularisation; they were fixed with lag screws to the roughened iliac bone above the acetabulum. We reviewed 84 hips (63 primary arthroplasties and 21 revisions) more than five years (mean 10.1) after operation. All but one of the grafts showed consolidation within three months and they had become structurally integrated with the iliac bone, as evidenced by the trabecular reorientation. Resorption, which has caused early socket failure when large bone grafts have been used, did not occur.

In acetabular dysplasia, fixation of the acetabular component of a cemented total hip prosthesis may be insecure and superolateral bone grafts are often used to augment the acetabular roof. We used finite element analysis to study the mechanical importance of the lateral acetabular roof and found that the lateral acetabular rim plays an important role in the load transfer of the pelvic bone. When the superlateral rim was lacking, the load shifted to the posterosuperior rim and to the area of pubic support, and the stresses in all materials, especially in the cement and in the trabecular bone, increased greatly. At the cement-bone interface the tilting component of the shear stress increased threefold. In a model in which the dysplastic acetabulum was augmented by a rigidly fixed, load-transmitting bone graft, the stresses were considerably diminished.

In a prospective study, 170 impacted femoral neck fractures were treated by early mobilisation and weight-bearing. The overall mortality at one year was 16%. In the 167 patients who were followed up until fracture healing or secondary instability, 143 fractures (86%) united. Instability occurred only in patients over 70 years of age, and in younger patients with a short life expectancy. Stepwise logistic regression analysis indicated that poor general health and old age (over 70 years) were risk factors. None of the other variables, such as the Garden index, Pauwels' type, and time to full weight-bearing had any influence on the development of secondary instability. Delayed operation after secondary instability caused no increase in mortality, nonunion or avascular necrosis. Functional treatment of all patients with impacted femoral neck fractures seems therefore to be justified.

We report our experience in 42 patients, using corticocancellous bone grafts and lag screw fixation for un-united scaphoid fractures. Using a grading system, we analysed the suitability of the method for three types of nonunion. We recommend the operation for the treatment of scaphoid nonunion, except where there is avascular necrosis of the proximal pole.

We have analysed 31 malunited ankle fractures treated by reconstructive osteotomies. In all cases the malunited fibula has been corrected; this has been combined with other osteotomies and with fixation of ununited fragments as indicated. Our results show that, unless function was severely impaired, reconstruction was always worth while, no matter how long ago the injury had occurred and even if there were already arthritic changes.

We report a series of 50 patients under 70 years of age who had an ununited femoral neck fracture treated by a Pauwels abduction osteotomy. At an average follow-up of 7.1 years, seven patients had required prosthetic replacement and 37 others were reviewed in detail. In these patients the Harris hip score averaged 91. Twenty-two hips showed radiographic evidence of avascular femoral head necrosis, but only three of these had been replaced. For active patients with non-union of a femoral neck fracture, Pauwels osteotomy provides a high proportion of good results even in the presence of avascular necrosis of the head, providing there has been no collapse. If osteotomy fails, prosthetic replacement is still possible.