Distal Bicep Tendon RuptureBRTNCT01322828
Trial Comparing Single Versus Double Incision to Repair Distal Bicep Tendon Ruptures
A study testing Distal bicep tendon reconstruction in people with Distal Bicep Tendon Rupture, run by Hand and Upper Limb Clinic, Canada at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Bicep Tendon Rupture
- What is being tested?
- Distal bicep tendon reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2004to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complete rupture of the Distal Bicep tendon
- Acute bicep tendon rupture (< 10 days since rupture)
- 18 years of age and older
Who cannot join
- Partial rupture of the Distal Bicep tendon
- Chronic bicep tendon Ruptures (>10 days since rupture)
- Under 18 years of age
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hand and Upper Limb Centre, St. Joseph's Health Care
London, Ontario, N6A4L6
Hand and Upper Limb Centre
London, Ontario, N6A4L6
About this study
Official title: Randomized Control Trial Comparing Single Incision Versus Double Incision Surgery to Repair Distal Bicep Tendon Ruptures
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.
- Conditions
- Distal Bicep Tendon Rupture
- Being tested
- Distal bicep tendon reconstruction
- Keywords
- Bicep, Tendon, Distal, Ruptures, Randomized, Surgery
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal bicep tendon reconstructionProcedure or surgery
Randomized to either a single incision technique or a double incision technique.
| Study group | Role | What they receive |
|---|---|---|
| Single incision repair of distal bicep tendon rupture | Active comparator | In this treatment arm patients will have a single incision technique used to repair their distal bicep tendon rupture Receives: Procedure: Distal bicep tendon reconstruction |
| Double incision repair of distal bicep tendon rupture | Active comparator | In this treatment arm, patients will have a double incision technique used to repair their distal bicep tendon rupture. Receives: Procedure: Distal bicep tendon reconstruction |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startMar 2004
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Bicep Tendon RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hand and Upper Limb Clinic, Canada
- Sponsor type
- Research network
- Investigators
- Joy MacDermid, MSc, PhD, Principal investigator, Hand and Upper Limb Centre, St Joseph's health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322828
- Sponsor's protocol ID
- HULCbicep
- Acronym
- BRT
- Status last verified
- Apr 2011
- First submitted
- 23 Mar 2011
- Last updated
- 11 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Comparing Single Incision Versus Double Incision Surgery to Repair Distal Bicep Tendon Ruptures
- ClinicalTrials.gov ID
- NCT01322828
- Acronym / sponsor ID
- BRT / HULCbicep
- Conditions
- Distal Bicep Tendon Rupture
- Keywords
- Bicep, Tendon, Distal, Ruptures, Randomized, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hand and Upper Limb Clinic, CanadaResearch network
- Study start
- Mar 2004
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single incision repair of distal bicep tendon rupture | Active comparator | Procedure: Distal bicep tendon reconstructionIn 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 comparator | Procedure: Distal bicep tendon reconstructionIn this treatment arm, patients will have a double incision technique used to repair their distal bicep tendon rupture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Complete rupture of the Distal Bicep tendon
- Acute bicep tendon rupture (< 10 days since rupture)
- 18 years of age and older
Key exclusion criteria (3 listed)
- Partial rupture of the Distal Bicep tendon
- Chronic bicep tendon Ruptures (>10 days since rupture)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal bicep tendon reconstructionRandomized to either a single incision technique or a double incision technique. | Procedure or surgery | Double incision repair of distal bicep tendon rupture, Single incision repair of distal bicep tendon rupture |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy MacDermid, MSc, PhD principal investigator
Hand and Upper Limb Centre, St Joseph's health Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal bicep tendon reconstruction in people with Distal Bicep Tendon Rupture, run by Hand and Upper Limb Clinic, Canada at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2011.