Treatment of reducible unstable fractures of the distal radius in adults: a randomised controlled trial of DePalma percutaneous pinning versus bridging external fixation

Background: At present, there is no conclusive evidence regarding the best treatment method for reducible unstable fractures of the distal radius. This study compared the effectiveness of two methods used in surgical treatment of such fractures: percutaneous pinning and external fixation. Methods: We randomly allocated 100 patients into two groups treated surgically with modified DePalma percutaneous pinning and bridging external fixation. Independent but not blinded evaluators administered the DASH quality-of-life questionnaire at postoperative months 6 and 24, performed functional assessment of pain, range of motion, and palm grip strength, and radiographic examinations (volar and radial angle, and height of the radius) before the operation, immediately afterwards, and at 6 and 24 months postoperative. Modified Depalma percutaneous pinning patients used above-elbow cast whereas external fixation group had unrestricted elbow motion after surgery. Patients who for any reason demonstrated treatment failure or required additional interventions were followed up and their results were included in the group into which these patients had initially been randomized according to the intention-to-treat principle. A significance level of 5% (alpha = 0.05) was used for all statistical tests, such that tests presenting a p-value less than 0.05 were considered statistically significant. Results: Ninety one (58,8 mean age and 66 participants were female) were included in the final assessment at 24 months. The DASH questionnaire evaluation showed a statistically significant result favouring the DePalma group (MD=-7.1007 p=0.044 95% CI) after six months, but this was not maintained in the final evaluation at 24 months. There were no statistically differences between the groups with respect to palm grip strength. Analysis of the range-of-motion limitation index (uninjured side minus affected side motion of) showed a statistical difference (MD= p =0.043 95% CI) favoring the external fixator group with regard to the supination movement 6 months after the operation; however, this was not maintained at 24 months. The final results of the radiographic evaluation were similar for the two groups. Overall, five patients developed complications: two with DePalma pinning and three with external fixation. Conclusion: There was a small statistical significant difference favouring the DePalma method in functional early analysis (6 months) according to the DASH questionnaire and for supination movement favouring the fixator group, however, both were not clinical relevant. In 24 months the groups were similar for all outcomes Trial registration: Current Controlled Trials ISRCTN04892785