NCT01322828

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Hand and Upper Limb Clinic, Canada · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Distal Bicep Tendon Rupture

Interventions

Type	Name	Description
PROCEDURE	Distal bicep tendon reconstruction	Randomized to either a single incision technique or a double incision technique.

Timeline

• Start date: 2004-03-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2011-03-25
• Last updated: 2011-04-11

Locations

2 sites across 1 country: Canada