Disorder of Tendon of BicepsNCT01317771
Analysis of the Fixation of the Proximal Biceps Tendon
An observational study of Disorder of Tendon of Biceps, run by West Penn Allegheny Health System at 1 site in United States.
Trial summary
Ten randomly selected patients that have undergone an open proximal biceps tendon tenodesis with an EndoButton for bicipital pathology with Christopher Schmidt, MD, will be asked to participate in the study. The study will assess the tendon healing to bone through magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disorder of Tendon of Biceps
- What is being tested?
- Open proximal biceps tendon tenodesis with an EndoButton
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2011to 1 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This research study will collect the MRI and questionnaire data from 10 subjects that have undergone a subpectoral proximal biceps tendon tenodesis using the EndoButton.
Who may be able to join
- Undergone open subpectoral proximal biceps tenodesis with the EndoButton
Who cannot join
- No history of surgery or disability in the contra-lateral extremity
- Not a member of a legally restricted group or protected population
- No prior surgery or further surgery on the extremity of interest
- No condition preventing the individual from undergoing a MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny Imaging of McCandless
Pittsburgh, Pennsylvania
About this study
Official title: Analysis of the Fixation of the Proximal Long Head of the Biceps Tendon
Ten randomly selected patients that have undergone an open proximal biceps tendon tenodesis with an EndoButton for bicipital pathology with Christopher Schmidt, MD, will be asked to participate in the study. The study will assess the tendon healing to bone through magnetic resonance imaging (MRI). Individuals will also be asked to fill a visual analog scale (VAS) pain and disability of the arm shoulder and hand (DASH) assessment tools. The variables for our objective will include age, hand dominance, gender and chronicity of symptoms prior to surgery, and other related surgical procedures.
- Conditions
- Disorder of Tendon of Biceps
- Being tested
- Open proximal biceps tendon tenodesis with an EndoButton
- Keywords
- Proximal Biceps Pathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open proximal biceps tendon tenodesis with an EndoButtonProcedure or surgery
Surgical fixation for bicipital pathology
| Study group | Role | What they receive |
|---|---|---|
| Proximal Biceps Tendon Tenodesis | Not described Receives: Procedure: Open proximal biceps tendon tenodesis with an EndoButton |
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 start11 Mar 2011
- Primary completion1 Mar 2013
- Study completion1 Mar 2013
Why it stopped: PI decided to not activate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Tendon of BicepsStudies 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
- Retrospective
- Enrolment
- 0 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
- NCT01317771
- Sponsor's protocol ID
- RC-5202
- Status last verified
- Aug 2020
- First submitted
- 16 Mar 2011
- Last updated
- 19 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Fixation of the Proximal Long Head of the Biceps Tendon
- ClinicalTrials.gov ID
- NCT01317771
- Acronym / sponsor ID
- RC-5202
- Conditions
- Disorder of Tendon of Biceps
- Keywords
- Proximal Biceps Pathology
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI decided to not activate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Study start
- 11 Mar 2011 (actual)
- Primary completion
- 1 Mar 2013 (actual)
- Study completion
- 1 Mar 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.
Ten randomly selected patients that have undergone an open proximal biceps tendon tenodesis with an EndoButton for bicipital pathology with Christopher Schmidt, MD, will be asked to participate in the study. The study will assess the tendon healing to bone through magnetic resonance imaging (MRI). Individuals will also be asked to fill a visual analog scale (VAS) pain and disability of the arm shoulder and hand (DASH) assessment tools. The variables for our objective will include age, hand dominance, gender and chronicity of symptoms prior to surgery, and other related surgical procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proximal Biceps Tendon Tenodesis | – | Procedure: Open proximal biceps tendon tenodesis with an EndoButton |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This research study will collect the MRI and questionnaire data from 10 subjects that have undergone a subpectoral proximal biceps tendon tenodesis using the EndoButton.
Key inclusion criteria (1 listed)
- Undergone open subpectoral proximal biceps tenodesis with the EndoButton
Key exclusion criteria (4 listed)
- No history of surgery or disability in the contra-lateral extremity
- Not a member of a legally restricted group or protected population
- No prior surgery or further surgery on the extremity of interest
- No condition preventing the individual from undergoing a 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 |
|---|---|---|
| Open proximal biceps tendon tenodesis with an EndoButtonSurgical fixation for bicipital pathology | Procedure or surgery | Proximal Biceps Tendon Tenodesis |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 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 Disorder of Tendon of Biceps, 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 4 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: withdrawn, as of the sponsor's last update on 19 Aug 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 was withdrawn before enrolling participants, so there are no results.
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 19 Aug 2020.