NCT01123447.
Trial name or title | A prospective randomized trial comparing open reduction and internal fixation with non‐operative treatment for ulnar shaft fractures |
Methods | Multi‐centre randomised controlled trial |
Participants | Skeletally mature patients (age 10 years of above) with isolated ulnar shaft fractures presenting within 14 days of their injury Estimated enrolment: 100 |
Interventions | 1. Surgery: open reduction and internal fixation using a limited contact dynamic compression (LC‐DC) plate with screws 2. Non‐operative treatment with closed reduction and short‐arm (below‐elbow) cast for 6 weeks |
Outcomes | Length of follow‐up: 1 year (also assessed: 2 weeks, 6 weeks, 12 weeks, 6 months) Primary outcome: Disabilities of the Arm, Shoulder and Hand (DASH) score Secondary outcomes: SF‐36, range of motion, pain, grip strength, return to work, and time to union |
Starting date | May 2010 Estimated study completion date: December 2015 |
Contact information | Contact: Kimberly D Carcary, kdcarcar@ucalgary.ca Chief Investigator: Dr. Paul Duffy, University of Calgary/Foothills Medical Centre |
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