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

Hand and Upper Limb Clinic, Canada

Status: Completed

Conditions: Distal Bicep Tendon Rupture

Treatments: Procedure: Distal bicep tendon reconstruction

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01322828

HULCbicep

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Single incision repair of distal bicep tendon rupture

Active Comparator group

Description:

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

Treatment:

Procedure: Distal bicep tendon reconstruction

Double incision repair of distal bicep tendon rupture

Active Comparator group

Description:

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

Treatment:

Procedure: Distal bicep tendon reconstruction