SLAP TearSLAPNCT02296554
Superior Labral Tear From Anterior to Posterior (SLAP) Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder
A study testing SLAP Repair and Biceps Tenodesis in people with SLAP Tear, run by HealthPartners Institute at 1 site in United States.
Trial summary
Biceps Tenodesis is currently advocated for older, less active patients, but to date is not often advocated for Superior Labral Tear from Anterior to Posterior (SLAP) tears in young, active patients. The ideal surgical management for this pathology is not clearly known. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- SLAP Tear
- What is being tested?
- SLAP Repair and Biceps Tenodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 30 Dec 2018
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primary isolated SLAP tear, confirmed on MRI
Who cannot join
- Concomitant procedure needed such as a labral repair, rotator cuff repair or distal clavicle excision.
- Revision Surgery
- Previous shoulder surgery
- Major medical illness
- Inability to speak or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
TRIA Orthopaedic Center
Bloomington, Minnesota, 55431
About this study
Official title: SLAP Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder: A Randomized Outcomes Study
Biceps Tenodesis is currently advocated for older, less active patients, but to date is not often advocated for Superior Labral Tear from Anterior to Posterior (SLAP) tears in young, active patients. The ideal surgical management for this pathology is not clearly known. More surgeons are using biceps tenodesis as a treatment for SLAP tears, including in the young, active population. If this study were to demonstrate that biceps tenodesis is similar to or better than SLAP repair, this would fundamentally change the treatment of SLAP tears. Perhaps more importantly, it would likely mean a less involved rehabilitation and earlier return to activities for patients with this pathology.
- Conditions
- SLAP Tear
- Being tested
- SLAP Repair, Biceps Tenodesis
- Keywords
- SLAP Repair, Biceps Tenodesis
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLAP RepairProcedure or surgery
SLAP repair for SLAP tear
Biceps TenodesisProcedure or surgery
Biceps tenodesis for SLAP tear
| Study group | Role | What they receive |
|---|---|---|
| SLAP Repair | Experimental | Patient will receive SLAP repair for their SLAP tear. Receives: Procedure: SLAP Repair |
| Biceps Tenodesis Repair | Experimental | Patient will receive biceps tenodesis repair for their SLAP tear. Receives: Procedure: Biceps Tenodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported function and pain
American Shoulder and Elbow Surgeons (ASES)
Measured: Baseline
Patient reported function and pain
ASES
Measured: 6 months
Patient reported function and pain
ASES
Measured: 1 year
Patient reported function and pain
ASES
Measured: 2 years
Patient reported function and pain
ASES
Measured: 5 years
Secondary outcomes (5)
Range of Motion & Strength
Shoulder/elbow range of motion and strength measurements
Measured: Baseline
Range of Motion
Shoulder/elbow range of motion
Measured: 3 months
Range of Motion & Strength
Shoulder/elbow range of motion and strength measurements
Measured: 6 months
Range of Motion & Strength
Shoulder/elbow range of motion and strength measurements
Measured: 1 year
Range of Motion & Strength
Shoulder/elbow range of motion and strength measurements
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJun 2014
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLAP TearStudies 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
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296554
- Sponsor's protocol ID
- 1401M47421
- Acronym
- SLAP
- Status last verified
- Nov 2018
- First submitted
- 10 Nov 2014
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLAP Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder: A Randomized Outcomes Study
- ClinicalTrials.gov ID
- NCT02296554
- Acronym / sponsor ID
- SLAP / 1401M47421
- Conditions
- SLAP Tear
- Keywords
- SLAP Repair, Biceps Tenodesis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- Jun 2014
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 20 Nov 2014 (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.
Biceps Tenodesis is currently advocated for older, less active patients, but to date is not often advocated for Superior Labral Tear from Anterior to Posterior (SLAP) tears in young, active patients. The ideal surgical management for this pathology is not clearly known. More surgeons are using biceps tenodesis as a treatment for SLAP tears, including in the young, active population. If this study were to demonstrate that biceps tenodesis is similar to or better than SLAP repair, this would fundamentally change the treatment of SLAP tears. Perhaps more importantly, it would likely mean a less involved rehabilitation and earlier return to activities for patients with this pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLAP Repair | Experimental | Procedure: SLAP RepairPatient will receive SLAP repair for their SLAP tear. |
| Biceps Tenodesis Repair | Experimental | Procedure: Biceps TenodesisPatient will receive biceps tenodesis repair for their SLAP tear. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primary isolated SLAP tear, confirmed on MRI
Key exclusion criteria (5 listed)
- Concomitant procedure needed such as a labral repair, rotator cuff repair or distal clavicle excision.
- Revision Surgery
- Previous shoulder surgery
- Major medical illness
- Inability to speak or read English
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 |
|---|---|---|
| SLAP RepairSLAP repair for SLAP tear | Procedure or surgery | SLAP Repair |
| Biceps TenodesisBiceps tenodesis for SLAP tear | Procedure or surgery | Biceps Tenodesis Repair |
Primary outcome
Patient reported function and pain
Time frame: Baseline
American Shoulder and Elbow Surgeons (ASES)
Patient reported function and pain
Time frame: 6 months
ASES
Patient reported function and pain
Time frame: 1 year
ASES
Patient reported function and pain
Time frame: 2 years
ASES
Patient reported function and pain
Time frame: 5 years
ASES
5 secondary outcomes
Range of Motion & Strength
Time frame: Baseline
Range of Motion
Time frame: 3 months
Range of Motion & Strength
Time frame: 6 months
Range of Motion & Strength
Time frame: 1 year
Range of Motion & Strength
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
Related trials for SLAP Tear
Recruiting
Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears
SLAP Lesion
Not yet recruitingObservational study
Reliability and Accuracy of a New Clinical Test for Biceps Lesions
Lesion of Long Head of Biceps, SLAP Lesion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLAP Repair and Biceps Tenodesis in people with SLAP Tear, run by HealthPartners Institute 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 5 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: stopped early, as of the sponsor's last update on 30 Oct 2019. 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 stopped early (reason given: Low enrollment). Results are not available in the source record.
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.
What does the primary outcome measure?
Patient reported function and pain (time frame: Baseline). The study lists 5 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 30 Oct 2019.