Arthroscopic Rotator CuffNCT02811757
Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps
A study testing tenotomy and tenodesis in people with Arthroscopic Rotator Cuff, run by CHU de Reims at 1 site in France.
Trial summary
Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often associated with cuff tendinopathy. The function of the LHB in the shoulder is still controversial and uncertain, whereas its function in the elbow is certain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroscopic Rotator Cuff
- What is being tested?
- tenotomy and tenodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Dec 2019
- 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
- surgery tenotomy or tenodesis type of the long head of the biceps (broken tendinopathy or not rotator cuff escaping a well conducted medical treatment and under a repair or cap pathology of the long head of the biceps during the arthroscopy)
- Patients treated in the orthopedic service of the Reims University Hospital
- Patients agreeing to participate in the research and who signed the informed consent
- Major patients.
Who cannot join
- prior Shoulder Surgery
- surgery scheduled contralateral shoulder
- patient protected by law
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
France, Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often associated with cuff tendinopathy. The function of the LHB in the shoulder is still controversial and uncertain, whereas its function in the elbow is certain. The biceps brachii is a flexor of the elbow and supinator of the forearm. Suppression of the pathologic long head of the biceps permits pain relief and is very reliable in the literature. Two options are available for the remaining tendon : simple tenotomy or tenodesis which consists to reattach the tendon to the humerus. Our hypothesis is that there is no difference in strength or endurance of the biceps brachii after tenotomy or tenodesis of the LHB. The aim of this study was to compare the strength and the endurance of the biceps brachii during supination and flexion after tenotomy or tenodesis of the LHB.
the investigators proposed a prospective and randomized study. All the patients treated in our department for an arthroscopic rotator cuff repair were included in this study after signed consent. Participants will complete isokinetic strength and endurance testing for elbow flexion and supination on the operative and nonoperative sides a minimum of 1 year after biceps tenotomy or tenodesis. The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and SSV at 6 weeks, 3 months, 6 months and one year.
- Conditions
- Arthroscopic Rotator Cuff
- Being tested
- tenotomy, tenodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenotomyProcedure or surgery
tenodesisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| tenodesis | Experimental | Not described Receives: Procedure: tenodesis |
| tenotomy | Active comparator | Not described Receives: Procedure: tenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Max Peak Torque supination
Measured: 1 year
Max peak Torque Flexion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startDec 2013
- Primary completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Rotator CuffStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811757
- Sponsor's protocol ID
- PA13049
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps
- ClinicalTrials.gov ID
- NCT02811757
- Acronym / sponsor ID
- PA13049
- Conditions
- Arthroscopic Rotator Cuff
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2019 (estimated)
- First posted
- 23 Jun 2016 (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.
Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often associated with cuff tendinopathy. The function of the LHB in the shoulder is still controversial and uncertain, whereas its function in the elbow is certain. The biceps brachii is a flexor of the elbow and supinator of the forearm. Suppression of the pathologic long head of the biceps permits pain relief and is very reliable in the literature. Two options are available for the remaining tendon : simple tenotomy or tenodesis which consists to reattach the tendon to the humerus. Our hypothesis is that there is no difference in strength or endurance of the biceps brachii after tenotomy or tenodesis of the LHB. The aim of this study was to compare the strength and the endurance of the biceps brachii during supination and flexion after tenotomy or tenodesis of the LHB.
the investigators proposed a prospective and randomized study. All the patients treated in our department for an arthroscopic rotator cuff repair were included in this study after signed consent. Participants will complete isokinetic strength and endurance testing for elbow flexion and supination on the operative and nonoperative sides a minimum of 1 year after biceps tenotomy or tenodesis. The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and SSV at 6 weeks, 3 months, 6 months and one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tenodesis | Experimental | Procedure: tenodesis |
| tenotomy | Active comparator | Procedure: tenotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- surgery tenotomy or tenodesis type of the long head of the biceps (broken tendinopathy or not rotator cuff escaping a well conducted medical treatment and under a repair or cap pathology of the long head of the biceps during the arthroscopy)
- Patients treated in the orthopedic service of the Reims University Hospital
- Patients agreeing to participate in the research and who signed the informed consent
- Major patients.
Key exclusion criteria (3 listed)
- prior Shoulder Surgery
- surgery scheduled contralateral shoulder
- patient protected by law
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 |
|---|---|---|
| tenotomy | Procedure or surgery | tenotomy |
| tenodesis | Procedure or surgery | tenodesis |
Primary outcome
Max Peak Torque supination
Time frame: 1 year
Max peak Torque Flexion
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tenotomy and tenodesis in people with Arthroscopic Rotator Cuff, run by CHU de Reims at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 24 Jun 2016. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier Ohl (326783272 ext. 33, xohl@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Max Peak Torque supination (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 24 Jun 2016.