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

N/A
Waitlist Available
Led By Joy MacDermid, MSc, PhD
Research Sponsored by Hand and Upper Limb Clinic, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Distal Bicep Tendon Rupture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Single incision repair of distal bicep tendon ruptureActive Control1 Intervention
In this treatment arm patients will have a single incision technique used to repair their distal bicep tendon rupture
Group II: Double incision repair of distal bicep tendon ruptureActive Control1 Intervention
In this treatment arm, patients will have a double incision technique used to repair their distal bicep tendon rupture.

Find a Location

Who is running the clinical trial?

Hand and Upper Limb Clinic, CanadaLead Sponsor
3 Previous Clinical Trials
169 Total Patients Enrolled
Joy MacDermid, MSc, PhDPrincipal InvestigatorHand and Upper Limb Centre, St Joseph's health Care
~4 spots leftby Dec 2025