Distal Bicep Tendon Rupture Clinical Trial
— BRTOfficial title:
Randomized Control Trial Comparing Single Incision Versus Double Incision Surgery to Repair Distal Bicep Tendon Ruptures
The purpose of this study to to determine whether a single incision technique or a double incision technique is more effective in the surgical treatment of distal bicep tendon ruptures. Patients will be randomized to one of the two techniques upon consenting to the study. Prior to surgery patients will have their elbow flexion, extension, pronation, and supination strength measured. Elbow Range of motion will also be measured in each of these four movements. A number of subjective questionnaires will also be administered to the patient prior to surgery. The identical objective tests and subjective questionnaires will be completed by the patient at intervals of three months, six months, one year, and two years following their surgery. Additional information from patients clinical visits may also be collected throughout the study.
| Status | Completed |
| Enrollment | 92 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Complete rupture of the Distal Bicep tendon - Acute bicep tendon rupture (< 10 days since rupture) - 18 years of age and older Exclusion Criteria: - Partial rupture of the Distal Bicep tendon - Chronic bicep tendon Ruptures (>10 days since rupture) - Under 18 years of age |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Hand and Upper Limb Centre | London | Ontario |
| Canada | Hand and Upper Limb Centre, St. Joseph's Health Care | London | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Hand and Upper Limb Clinic, Canada |
Canada,