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

NCT01322828 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2011-04-11

No results posted yet for this study

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

PROCEDURE

Distal bicep tendon reconstruction

Randomized to either a single incision technique or a double incision technique.

Sponsors & Collaborators

  • Hand and Upper Limb Clinic, Canada

    lead NETWORK

Principal Investigators

  • Joy MacDermid, MSc, PhD · Hand and Upper Limb Centre, St Joseph's health Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01322828 on ClinicalTrials.gov