A prospective randomised, controlled clinical trial comparing medial and lateral entry pinning with lateral entry pinning for percutaneous fixation of displaced extension type supracondylar fractures of the humerus in children

摘要

Objective To compare the efficacy of medial and lateral entry pinning with lateral entry pinning for percutaneous fixation of displaced (Gartland type II and type III) extension type supracondylar fractures of the humerus in children. Methods The study was a single center, prospective, randomized controlled clinical trial. Between October 2007 and September 2010, 160 patients who satisfy the inclusion and exclusion criterias were enrolled in the study, with 80 patients in each group. All the percutaneous pinning was done according to a uniform standardized technique. The patients were re-evaluated as outpatients at three weeks, six weeks and three months after the surgery. At three months follow-up visit, following informations were recorded as outcome measures: (i) Carrying angle (deg) (ii) passive range of elbow motion (deg) (iii) Flynn's criteria for grading, based on the loss of carrying angle and loss of total range of elbow motion. (iv) Baumann angle (deg) (v) Change in Baumann angle (deg) between the Intraoperative radiographs after the surgery and radiographs at three months follow-up visit (vi) loss of reduction grading, based on the change in the Baumann angle. Results There were no significant differences between the two groups with regard to base-line characteristics, withdrawals and complication rate. At three months follow-up visit, patients were evaluated by recording the various outcome measures. There were no significant differences between the two groups with regard to the various outcome measures such as carrying angle, passive range of elbow motion, Flynn grading, Baumann angle, change in the Baumann angle and loss of reduction grading. Conclusions If a uniform standardized operative technique is followed in each method, then the result of both the percutaneous fixation methods will be same in terms of safety and efficacy.