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

NCT ID: NCT01322828

Last Updated: 2011-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Distal Bicep Tendon Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Distal bicep tendon reconstruction

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Distal bicep tendon reconstruction

Intervention Type PROCEDURE

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

Interventions

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Distal bicep tendon reconstruction

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hand and Upper Limb Clinic, Canada

NETWORK

Sponsor Role lead

Responsible Party

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Hand and Upper Limb Centre, St. Josephs Hospital

Principal Investigators

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Joy MacDermid, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Hand and Upper Limb Centre, St Joseph's health Care

Locations

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

London, Ontario, Canada

Site Status

Hand and Upper Limb Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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HULCbicep

Identifier Type: -

Identifier Source: org_study_id

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