Type 2 SLAP LesionsNCT02107547
Outcomes of Biceps Tenodesis or Labral Repair for Treatment of Type 2 Superior Labrum Anterior and Posterior Lesions
A study testing Biceps tenodesis and Labral repair in people with Type 2 SLAP Lesions, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of the study is to determine which of the two alternative surgical interventions (biceps tenodesis or labrum repair surgery) is better in the treatment of Type 2 Superior Labrum Anterior and Posterior lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 SLAP Lesions
- What is being tested?
- Biceps tenodesis and Labral repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2013to 11 Apr 2017
- 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
- patients with MRI diagnosed Superior Labrum Anterior and Posterior 2 lesion
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Evaluation of Biceps Tenodesis vs Labral Repair for Type 2 Superior Labrum Anterior and Posterior Lesions, A Randomized Controlled Trial
The purpose of the study is to determine which of the two alternative surgical interventions (biceps tenodesis or labrum repair surgery) is better in the treatment of Type 2 Superior Labrum Anterior and Posterior lesions.
Read the detailed description
The labrum is a structure which provides stability to the shoulder joint. A superior labral tear from anterior to posterior lesion is an injury to the labrum at the insertion of the biceps muscle. The grading system is related to the severity of the tear. A type 2 tear is an intermediate grade tear. These are commonly treated in two ways: either by repairing the labrum with bone anchors or by cutting the biceps tendon and re-affixing it more distally. No method has been shown to be superior to the other and surgeons generally choose to proceed however they are most comfortable. The study will seek to determine how these injuries are best treated. Inclusion criteria: patients with type 2 superior labral tear from anterior to posterior tears who are under the age of 45. Throwing athletes are excluded due to their unique demands.
Subjects will be randomly assigned to one of two groups. Prior to surgery patients will be evaluated in clinic, full histories and physicals will be performed and their functional status will be evaluated using validated questionnaires including the American Shoulder and Elbow Society score and quality of life measurements.
Both groups will be treated first with a shoulder arthroscopy. The experimental portion of the study will involve whether the patient is then treated with repair of the Superior Labrum Anterior and Posterior lesion or with tenodesis. Repair of a Superior Labrum Anterior and Posterior lesion involves placing small anchors in the glenoid to re-attach the torn labrum. A biceps tenodesis involves cutting the tendon within the shoulder joint and reattached further down the arm. Physical therapy will be initiated after surgery and will be identical in both groups. It will be recommended but not required as part of the study. Progress notes, operative reports, and questionnaires will also be retained as part of the study. Patients will be in a sling for the first 4 weeks after surgery. Post-operatively, physical examinations findings and American Shoulder and Elbow Surgeons scores at 3, 6, and 12 months. These will be compared to the preoperative results and to the other experimental arm of the study. Post-operative imaging will not be obtained. No computerized tomographies will be required as part of the study. No Magnetic Resonance Imagings will be required as part of the study--patients enrolled in the study will likely have had an MRI performed outside of the study period to determine if they have an isolated Superior Labrum Anterior and Posterior tear but no MRIs will be performed as part of the study. No lab reports or Physical therapy reports will be included in the study.
- Conditions
- Type 2 SLAP Lesions
- Being tested
- Biceps tenodesis, Labral repair
- Keywords
- Randomized Controlled Trial (RCT), Type 2 SLAP lesions, labral tear, biceps tenodesis, shoulder surgery, RCT, Comparison between two alternative surgical procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biceps tenodesisProcedure or surgery
A biceps tenodesis involves cutting the tendon within the shoulder joint and reattached further down the arm.
Labral repairProcedure or surgery
Repair of a Superior Labrum Anterior and Posterior lesion involves placing small anchors in the glenoid to re-attach the torn labrum.
| Study group | Role | What they receive |
|---|---|---|
| Biceps tenodesis | Active comparator | 32 subjects in the study will receive biceps tenodesis as a surgical intervention Receives: Procedure: Biceps tenodesis |
| Labral repair | Active comparator | 32 subjects in the study will receive labral repair as a surgical intervention Receives: Procedure: Labral repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.
Measured: one year
Secondary outcomes (1)
EuroQol five dimensions
The questionnaire measures mobility, ability to care for self, ability to perform usual activities, pain/discomfort, and anxiety/depression
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start23 May 2013
- Primary completion11 Apr 2017
- Study completion11 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 SLAP LesionsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lewis L Shi, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107547
- Sponsor's protocol ID
- IRB 13-0085
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2014
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biceps Tenodesis vs Labral Repair for Type 2 Superior Labrum Anterior and Posterior Lesions, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02107547
- Acronym / sponsor ID
- IRB 13-0085
- Conditions
- Type 2 SLAP Lesions
- Keywords
- Randomized Controlled Trial (RCT), Type 2 SLAP lesions, labral tear, biceps tenodesis, shoulder surgery, RCT, Comparison between two alternative surgical procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 23 May 2013 (actual)
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 8 Apr 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.
The purpose of the study is to determine which of the two alternative surgical interventions (biceps tenodesis or labrum repair surgery) is better in the treatment of Type 2 Superior Labrum Anterior and Posterior lesions.
Detailed description
The labrum is a structure which provides stability to the shoulder joint. A superior labral tear from anterior to posterior lesion is an injury to the labrum at the insertion of the biceps muscle. The grading system is related to the severity of the tear. A type 2 tear is an intermediate grade tear. These are commonly treated in two ways: either by repairing the labrum with bone anchors or by cutting the biceps tendon and re-affixing it more distally. No method has been shown to be superior to the other and surgeons generally choose to proceed however they are most comfortable. The study will seek to determine how these injuries are best treated. Inclusion criteria: patients with type 2 superior labral tear from anterior to posterior tears who are under the age of 45. Throwing athletes are excluded due to their unique demands.
Subjects will be randomly assigned to one of two groups. Prior to surgery patients will be evaluated in clinic, full histories and physicals will be performed and their functional status will be evaluated using validated questionnaires including the American Shoulder and Elbow Society score and quality of life measurements.
Both groups will be treated first with a shoulder arthroscopy. The experimental portion of the study will involve whether the patient is then treated with repair of the Superior Labrum Anterior and Posterior lesion or with tenodesis. Repair of a Superior Labrum Anterior and Posterior lesion involves placing small anchors in the glenoid to re-attach the torn labrum. A biceps tenodesis involves cutting the tendon within the shoulder joint and reattached further down the arm. Physical therapy will be initiated after surgery and will be identical in both groups. It will be recommended but not required as part of the study. Progress notes, operative reports, and questionnaires will also be retained as part of the study. Patients will be in a sling for the first 4 weeks after surgery. Post-operatively, physical examinations findings and American Shoulder and Elbow Surgeons scores at 3, 6, and 12 months. These will be compared to the preoperative results and to the other experimental arm of the study. Post-operative imaging will not be obtained. No computerized tomographies will be required as part of the study. No Magnetic Resonance Imagings will be required as part of the study--patients enrolled in the study will likely have had an MRI performed outside of the study period to determine if they have an isolated Superior Labrum Anterior and Posterior tear but no MRIs will be performed as part of the study. No lab reports or Physical therapy reports will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biceps tenodesis | Active comparator | Procedure: Biceps tenodesis32 subjects in the study will receive biceps tenodesis as a surgical intervention |
| Labral repair | Active comparator | Procedure: Labral repair32 subjects in the study will receive labral repair as a surgical intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with MRI diagnosed Superior Labrum Anterior and Posterior 2 lesion
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Biceps tenodesisA biceps tenodesis involves cutting the tendon within the shoulder joint and reattached further down the arm. | Procedure or surgery | Biceps tenodesis |
| Labral repairRepair of a Superior Labrum Anterior and Posterior lesion involves placing small anchors in the glenoid to re-attach the torn labrum. | Procedure or surgery | Labral repair |
Primary outcome
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time frame: one year
The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.
1 secondary outcome
EuroQol five dimensions
Time frame: one year
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 26 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Type 2 SLAP Lesions
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.
Lewis L Shi, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biceps tenodesis and Labral repair in people with Type 2 SLAP Lesions, run by University of Chicago 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 1 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 26 Apr 2023. 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.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons (ASES) Shoulder Score (time frame: one year). 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 26 Apr 2023.