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

April 8, 2011 updated by: Hand and Upper Limb Clinic, Canada

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A4L6
        • Hand and Upper Limb Centre, St. Joseph's Health Care
      • London, Ontario, Canada, N6A4L6
        • Hand and upper Limb Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hand and Upper Limb Clinic, Canada

Investigators

  • Principal Investigator: Joy MacDermid, MSc, PhD, Hand and Upper Limb Centre, St Joseph's Health Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 24, 2011

First Posted (Estimate)

March 25, 2011

Study Record Updates

Last Update Posted (Estimate)

April 11, 2011

Last Update Submitted That Met QC Criteria

April 8, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULCbicep

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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