Trial Comparing Single Versus Double Incision to Repair Distal Bicep Tendon Ruptures

Not Applicable

Completed

• Conditions: Distal Bicep Tendon Rupture
• Interventions: Procedure: Distal bicep tendon reconstruction

• Registration Number: NCT01322828
• Lead Sponsor: Hand and Upper Limb Clinic, Canada

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-08
• Last Update Posted: 2011-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single incision repair of distal bicep tendon rupture	Distal bicep tendon reconstruction	In this treatment arm patients will have a single incision technique used to repair their distal bicep tendon rupture
Double incision repair of distal bicep tendon rupture	Distal bicep tendon reconstruction	In this treatment arm, patients will have a double incision technique used to repair their distal bicep tendon rupture.

Trial Locations

Locations (2)

Hand and Upper Limb Centre; 🇨🇦 London, Ontario, Canada

Hand and Upper Limb Centre, St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada