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

This study has been completed.
Sponsor:
Information provided by:
Hand and Upper Limb Clinic, Canada
ClinicalTrials.gov Identifier:
NCT01322828
First received: March 23, 2011
Last updated: April 8, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Distal Bicep Tendon Rupture
Procedure: Distal bicep tendon reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial Comparing Single Incision Versus Double Incision Surgery to Repair Distal Bicep Tendon Ruptures

Further study details as provided by Hand and Upper Limb Clinic, Canada:

Enrollment: 92
Study Start Date: March 2004
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322828

Locations
Canada, Ontario
Hand and Upper Limb Centre
London, Ontario, Canada, N6A4L6
Hand and Upper Limb Centre, St. Joseph's Health Care
London, Ontario, Canada, N6A4L6
Sponsors and Collaborators
Hand and Upper Limb Clinic, Canada
Investigators
Principal Investigator: Joy MacDermid, MSc, PhD Hand and Upper Limb Centre, St Joseph's health Care
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Joy MacDermid, Hand and Upper Limb Centre, St. Josephs Hospital
ClinicalTrials.gov Identifier: NCT01322828     History of Changes
Other Study ID Numbers: HULCbicep
Study First Received: March 23, 2011
Last Updated: April 8, 2011
Health Authority: Canada: Office of Research Ethics University of Western Ontario

Keywords provided by Hand and Upper Limb Clinic, Canada:
Bicep
Tendon
Distal
Ruptures
Randomized
Surgery

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014