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

Primary Purpose

Distal Bicep Tendon Rupture

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Distal bicep tendon reconstruction
Sponsored by
Hand and Upper Limb Clinic, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Bicep Tendon Rupture focused on measuring Bicep, Tendon, Distal, Ruptures, Randomized, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hand and Upper Limb Centre, St. Joseph's Health Care
  • Hand and Upper Limb Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single incision repair of distal bicep tendon rupture

Double incision repair of distal bicep tendon rupture

Arm Description

In this treatment arm patients will have a single incision technique used to repair their distal bicep tendon rupture

In this treatment arm, patients will have a double incision technique used to repair their distal bicep tendon rupture.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 23, 2011
Last Updated
April 8, 2011
Sponsor
Hand and Upper Limb Clinic, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01322828
Brief Title
Trial Comparing Single Versus Double Incision to Repair Distal Bicep Tendon Ruptures
Acronym
BRT
Official Title
Randomized Control Trial Comparing Single Incision Versus Double Incision Surgery to Repair Distal Bicep Tendon Ruptures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hand and Upper Limb Clinic, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Bicep Tendon Rupture
Keywords
Bicep, Tendon, Distal, Ruptures, Randomized, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single incision repair of distal bicep tendon rupture
Arm Type
Active Comparator
Arm Description
In this treatment arm patients will have a single incision technique used to repair their distal bicep tendon rupture
Arm Title
Double incision repair of distal bicep tendon rupture
Arm Type
Active Comparator
Arm Description
In this treatment arm, patients will have a double incision technique used to repair their distal bicep tendon rupture.
Intervention Type
Procedure
Intervention Name(s)
Distal bicep tendon reconstruction
Intervention Description
Randomized to either a single incision technique or a double incision technique.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy MacDermid, MSc, PhD
Organizational Affiliation
Hand and Upper Limb Centre, St Joseph's health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hand and Upper Limb Centre, St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4L6
Country
Canada
Facility Name
Hand and Upper Limb Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4L6
Country
Canada

12. IPD Sharing Statement

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

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