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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01322828
Acronym
BRT
Enrollment
92
Registered
2011-03-25
Start date
2004-03-31
Completion date
2010-01-31
Last updated
2011-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Bicep Tendon Rupture

Keywords

Bicep, Tendon, Distal, Ruptures, Randomized, Surgery

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.

Interventions

PROCEDUREDistal bicep tendon reconstruction

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

Sponsors

Hand and Upper Limb Clinic, Canada
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026