Biceps Tendon RuptureNCT01317719
Prospective Biceps Study
An observational study of Biceps Tendon Rupture, run by West Penn Allegheny Health System at 1 site in United States.
Trial summary
The primary goal of this study is to determine if surgical repair of the distal biceps fully restores the supination strength of the forearm. Secondarily, the investigators want to examine the insertion site location of the tendon and determine if it correlates with the patients' functional outcome as determined by… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biceps Tendon Rupture
- What is being tested?
- Distal Biceps Re-Insertion Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2011to 30 Dec 2013
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have received primary distal biceps repair by Dr. Schmidt
Who may be able to join
- primary distal biceps repair with endobutton
Who cannot join
- any ipsilateral wrist, forearm, or elbow condition
- any contraindication to having an MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny Imaging of McCandless
Pittsburgh, Pennsylvania
About this study
The primary goal of this study is to determine if surgical repair of the distal biceps fully restores the supination strength of the forearm. Secondarily, the investigators want to examine the insertion site location of the tendon and determine if it correlates with the patients' functional outcome as determined by Disabilities of the Arm, Shoulder, and Hand (DASH), Visual Analog Pain Scale (VAPS), and isometric supination torque testing.
- Conditions
- Biceps Tendon Rupture
- Being tested
- Distal Biceps Re-Insertion Surgery
- Keywords
- Rupture of Distal Bicep Tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal Biceps Re-Insertion SurgeryProcedure or surgery
Surgical Repair of the Distal Biceps Tendon
| Study group | Role | What they receive |
|---|---|---|
| Distal Biceps Ruptures | Not described Receives: Procedure: Distal Biceps Re-Insertion Surgery |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study start14 Jan 2011
- Primary completion30 Dec 2013
- Study completion30 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biceps 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Penn Allegheny Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Latona, West Penn Allegheny Health System
- Investigators
- Christopher C Schmidt, MD, Principal investigator, WPAHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317719
- Sponsor's protocol ID
- RC-5159
- Status last verified
- Sep 2020
- First submitted
- 16 Mar 2011
- Last updated
- 18 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Biceps Study
- ClinicalTrials.gov ID
- NCT01317719
- Acronym / sponsor ID
- RC-5159
- Conditions
- Biceps Tendon Rupture
- Keywords
- Rupture of Distal Bicep Tendon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Study start
- 14 Jan 2011 (actual)
- Primary completion
- 30 Dec 2013 (actual)
- Study completion
- 30 Dec 2013 (actual)
- First posted
- 17 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 primary goal of this study is to determine if surgical repair of the distal biceps fully restores the supination strength of the forearm. Secondarily, the investigators want to examine the insertion site location of the tendon and determine if it correlates with the patients' functional outcome as determined by Disabilities of the Arm, Shoulder, and Hand (DASH), Visual Analog Pain Scale (VAPS), and isometric supination torque testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal Biceps Ruptures | – | Procedure: Distal Biceps Re-Insertion Surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received primary distal biceps repair by Dr. Schmidt
Key inclusion criteria (1 listed)
- primary distal biceps repair with endobutton
Key exclusion criteria (2 listed)
- any ipsilateral wrist, forearm, or elbow condition
- any contraindication to having an MRI
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 Biceps Re-Insertion SurgerySurgical Repair of the Distal Biceps Tendon | Procedure or surgery | Distal Biceps Ruptures |
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 18 Sep 2020.
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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.
Christopher C Schmidt, MD principal investigator
WPAHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biceps Tendon Rupture, run by West Penn Allegheny Health System at 1 site in United States.
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 1 inclusion and 2 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 18 Sep 2020.