Trial Comparing Single Versus Double Incision to Repair Distal Bicep Tendon Ruptures
BRT
Randomized Control Trial Comparing Single Incision Versus Double Incision Surgery to Repair Distal Bicep Tendon Ruptures
1 other identifier
interventional
92
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2004
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 23, 2011
CompletedFirst Posted
Study publicly available on registry
March 25, 2011
CompletedApril 11, 2011
April 1, 2011
5.8 years
March 23, 2011
April 8, 2011
Conditions
Keywords
Study Arms (2)
Single incision repair of distal bicep tendon rupture
ACTIVE COMPARATORIn this treatment arm patients will have a single incision technique used to repair their distal bicep tendon rupture
Double incision repair of distal bicep tendon rupture
ACTIVE COMPARATORIn this treatment arm, patients will have a double incision technique used to repair their distal bicep tendon rupture.
Interventions
Randomized to either a single incision technique or a double incision technique.
Eligibility Criteria
You may qualify if:
- Complete rupture of the Distal Bicep tendon
- Acute bicep tendon rupture (\< 10 days since rupture)
- years of age and older
You may not qualify if:
- Partial rupture of the Distal Bicep tendon
- Chronic bicep tendon Ruptures (\>10 days since rupture)
- Under 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hand and Upper Limb Centre, St. Joseph's Health Care
London, Ontario, N6A4L6, Canada
Hand and Upper Limb Centre
London, Ontario, N6A4L6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joy MacDermid, MSc, PhD
Hand and Upper Limb Centre, St Joseph's health Care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
March 23, 2011
First Posted
March 25, 2011
Study Start
March 1, 2004
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
April 11, 2011
Record last verified: 2011-04