Randomised controlled clinical trials (RCTs) produce the most reliable evidence about the effects of clinical care. In surgical trials, lack of surgeons’ individual equipoise (state of genuine uncertainty about treatment arms) appears to be one of the greatest obstacles. Collective equipoise based on present or imminent controversy in the expert medical community has been proposed as a solution (Freedman, 1987), but could be applied only at the beginning of a trial to a general trial question. We developed a system that quantifies collective uncertainty among a group of surgeons for an individual clinical case. After a successful pilot study the system was introduced as an independent project within the UK Heel Fracture Trial. The expert panel included 10 surgeons from 8 hospitals. Anonymous clinical data of potentially eligible consecutive cases including CT and X-ray images was published on a secure online forum after 6 weeks follow up clinic to avoid interference with clinical course. Surgeons registered in the panel estimated the probability that the patient would be better or worse by various degrees with operative treatment. 30 clinical cases have been analysed, including 6 bilateral fractures (otherwise excluded). 86.7% could be recommended for inclusion in the trial, compared to 43.3% recruited out of this series in the actual trial. Lack of individual uncertainty within the panel was present in every case. The system not only has a potential to improve recruitment in surgical RCTs, but provides ethically sound grounds to offer or otherwise a patient participation in a trial. Surgeon’s individual equipoise dilemma and responsibility is shared with colleagues. Cases that otherwise will be excluded can be evaluated with broader inclusion criteria. The system is easy to use, cheap and reliable. Limitations include surgeons’ compliance and time lapse (at least 48 hours) for voting to be completed.
The amount of bone formed under each condition was assessed by solubilising the mineral content in hydrochloric acid overnight and then measuring the change in colour induced by Calcium exposed to a commercial reagent. The amount of calcium detected was then determined using a standard curve. This experiment was repeated in cells from 3 patients.
There was a statistically significant impairment in osteogenesis at a concentration of tobramycin of 400 microg/ml and above.
Subacromial corticosteroid injection has been shown to be effective in treating impingement syndrome. The exact mechanism of action is not clear but it may be due to its anti-inflammatory properties. However, there are potential side effects of steroid injection including tendon weakening, dermal atrophy and infection. NSAIDs may offer similar anti-inflammatory properties but without the side effects of corticosteroids. Tenoxicam is a long-acting water soluble NSAID and is available without irritant preservatives. Studies have shown that peri-articular Tenocixam injection was useful in treating painful shoulders and local tolerability was good. The aim of this study is to carry out a blinded ran-domised controlled study comparing subacromial Tenoxicam injection (NSAID) against methylprednisolone (steroid) injection in patients with clinical subacromial impingement syndrome. The study protocol was approved by local research ethics committee. Patients over 18 with a clinical diagnosis of subacromial impingement syndrome were considered eligible to this study. Patients with other known causes of shoulder pain, contraindication or sensitivity to NSAID and pregnant patients were excluded. Three functional outcome measures were used – Constant-Murley Shoulder Score, DASH and the Oxford Shoulder Score. The patients completed all three outcome measures before and 2, 4 and 6 weeks after the subacromial injection. Simple randomisation method was used and blinded to both researcher and the patient. 58 patients randomised into two groups were reviewed at the end of six weeks. Patients treated with subacromial steroid injection had a much better outcome compared to patients treated with subacromial tenoxicam injection and this difference was highly significant (p<
.003) In conclusion, patients with subacromial impingement syndrome have a better clinical outcome when treated with subacromial steroid injection than NSAID injection.
We applied the technique of path analysis to investigate the effect of potential prognostic factors, including injury characteristics and treatment choices, on the risk of delayed healing or non-union after operative treatment of tibial shaft fractures. Data were collected in a prospective observational study of 41 Swiss hospitals over two years, and analysed by regression models and path analysis. Path analysis is a technique to visualize the most important associations between clinical factors and outcome in a ‘causal path diagram’ that summarises the most likely cause and effect relationships. Factors having a direct relationship with the occurrence of delayed healing or non-union included open fracture (RR 6.7), distal shaft location (RR 2.2), and initial treatment with an external fixator (RR 2.8). There were many other significant inter-relationships within the final diagram. For example, the choice of treatment was related to factors such as fracture aetiology, AO classification, location and skin injury. Fracture classification was not associated with delayed healing and non-union after adjustment for other factors including treatment choice. The association of hypothesised risk factors, such as soft tissue injury and fracture location, with delayed healing or non-union was confirmed and measured. This study suggested that the use of an external fixator had a direct, negative effect on outcome, and that the use of nails or plates might contribute to delayed healing or non-union by their association with post-operative diastasis. These observations support this first use of path analysis in orthopaedics as a powerful technique to interpret data from an observational study.
To assess whether epidural steroid injection [ESI] is effective in the treatment of nerve root pathology caused by compression in the lumbar spine secondary to either spinal stenosis or disc prolapse, we carried out a prospective randomised controlled trial; patients were randomised either to ESI or Intramuscular steroid injection, with minimum two year follow-up. Ninety two patients with symptoms, signs and radiological findings consistent with lumbar nerve root compression suitable for surgical decompression. The main outcome measures were the Oxford Pain Chart over the first month, Oswestry Disability Index, and the need for surgery. There was a significant reduction in pain early on after ESI compared with controls [p=<
0.004] between 10 and 35 days. There was no difference in the long term between the two groups and the rate of surgery in the two groups was not significantly different. Indeed the rate of surgery was higher in the ESI group than the control group [41% vs.31%] but this was not significant. A second ESI did not change the likelihood that surgery would be required.
Hip and knee arthroplasty has been associated with relatively high rates of thromboembolic events and the majority of UK orthopaedic surgeons use at least one form of prophylaxis. Of the many different subgroups of thromboembolic rates that are commonly presented in the literature, symptomatic proximal deep vein thrombosis (spDVT) and fatal pulmonary embolism (fPE) are perhaps the most important clinical outcomes. To determine the effectiveness of common chemical and mechanical prophylactic methods in preventing spDVT and fPE in patients undergoing primary hip and knee arthroplasty. A systematic review of the literature from 1981 to December 2002 was performed. Predetermined inclusion and exclusion criteria were applied. Studies where more than one method of prophylaxis was used were excluded from analysis. For each individual method of prophylaxis, data was extracted, combined and converted to give estimates of the rates of spDVT, fPE and major bleeding events. Absolute risk reduction estimates for spDVT, fPE and major bleeding events were calculated by comparing the thromboembolic rates for each method of prophylaxis with using no prophylaxis of any kind. 992 studies were identified of which 162 met the inclusion criteria. No method of prophylaxis was statistically significantly more effective at preventing spDVT and fPE than using nothing. There were at least as many major bleeding complications as spDVTs. The number of fPEs prevented was very small. When complications such as major bleeding are considered, the evidence behind the use of any prophylaxis is unconvincing.
Group A included 84 shoulders treated by arthroscopic lavage without stabilisation. There were no subluxations. The re-dislocation rate was 14.3% (12/84). Group B had 179 shoulders treated by arthroscopic stabilisation. The incidence of subluxation was 5.02% (9/179) and dislocation was 6.14% (11/179). Recurrent instability (subluxation /dislocation) following arthroscopic lavage (12/84 – 14.3%) was significantly higher than after arthroscopic stabilisation (20/179 – 11.2%). [p= 0.04, Relative risk = 2.32, 95% CI: 1.07 to 5.05] Group C involved 170 shoulders treated non-operatively. The incidence of subluxation was 8% (12/150) and dislocation was 62% (93/150). The overall incidence of recurrent instability was 70% (119/170). Recurrent instability following arthroscopic intervention (32/263 – 12.2%) was significantly lower than following non-operative treatment (119/170 – 70%) [p<
0.0001, Relative risk = 0.17, 95% CI: 0.12 to 0.24].
A non-evaluative culture; Misunderstanding of the scientific basis of trial design; Lack of individual equipoise; The complexity of the relationship between patient and surgeon; Inadequate measures of outcome; Practical problems associated with long follow-up, clinical work load and lack of funding.
Rheumatoid arthritis results in pain and loss of function due to gradual destruction of articular cartilage. The shoulder joint is frequently involved and a prosthetic replacement of the humeral head can restore function and relieve pain. Deficiency of the rotator cuff is common in patients with rheumatoid arthritis. Longevity of movement at the intraprosthetic interface of the bipolar shoulder prosthesis is debatable and has not previously been studied in rheumatoid arthritis. We report a radiological study of the intraprosthetic movements of a bipolar shoulder replacement in 25 shoulders in 20 patients with rheumatoid arthritis of mean age 66 years (SD 10 years). Shoulders were X-rayed at a minimum of 3 and a maximum of 10 years from surgery. Measurements were repeated in 12 shoulders 3 years later. The patient was positioned in the scapular plane. An initial X-ray was taken with the arm in neutral and a further X-ray taken with the arm in full active abduction. Measurements were taken to determine the movement at the intraprosthetic interface and at the prosthesis/glenoid interface. Interobserver error and intraobserver error were determined using an intraclass correlation coefficient (ICC). A paired T-test and Pearson Correlation Coefficient were used to compare intraprosthetic movement with prosthesis/glenoid movement. We found that intraprosthetic movement was preserved up to 10 years from surgery. However, there was no significant difference between intraprosthetic movement and shell/glenoid movement, with some shoulders exhibiting paradoxical movement at the intraprosthetic interface. Repeating the measurements after a 3 year interval in a subgroup of 12 shoulders showed a significant difference in intraprosthetic movement. Interobserver and intraobserver reliability for measurements of the movement at the intraprosthetic interface were excellent with a We conclude that movement of the bipolar shoulder prosthesis in rheumatoid shoulders at the intraprosthetic interface is preserved up to 10 years from operation but is not related to or significantly different from prosthesis/glenoid movement and requires further investigation.