Trial Comparing Single Versus Double Incision to Repair Distal Bicep Tendon Ruptures (BRT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Distal Bicep Tendon Rupture |
Procedure: Distal bicep tendon reconstruction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Control Trial Comparing Single Incision Versus Double Incision Surgery to Repair Distal Bicep Tendon Ruptures |
| Enrollment: | 92 |
| Study Start Date: | March 2004 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Single incision repair of distal bicep tendon rupture
In this treatment arm patients will have a single incision technique used to repair their distal bicep tendon rupture
|
Procedure: Distal bicep tendon reconstruction
Randomized to either a single incision technique or a double incision technique.
|
|
Active Comparator: Double incision repair of distal bicep tendon rupture
In this treatment arm, patients will have a double incision technique used to repair their distal bicep tendon rupture.
|
Procedure: Distal bicep tendon reconstruction
Randomized to either a single incision technique or a double incision technique.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Ontario | |
| Hand and Upper Limb Centre | |
| London, Ontario, Canada, N6A4L6 | |
| Hand and Upper Limb Centre, St. Joseph's Health Care | |
| London, Ontario, Canada, N6A4L6 | |
| Principal Investigator: | Joy MacDermid, MSc, PhD | Hand and Upper Limb Centre, St Joseph's health Care |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Joy MacDermid, Hand and Upper Limb Centre, St. Josephs Hospital |
| ClinicalTrials.gov Identifier: | NCT01322828 History of Changes |
| Other Study ID Numbers: | HULCbicep |
| Study First Received: | March 23, 2011 |
| Last Updated: | April 8, 2011 |
| Health Authority: | Canada: Office of Research Ethics University of Western Ontario |
Keywords provided by Hand and Upper Limb Clinic, Canada:
|
Bicep Tendon Distal |
Ruptures Randomized Surgery |
Additional relevant MeSH terms:
|
Tendon Injuries Rupture, Spontaneous Rupture Wounds and Injuries Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 22, 2013