Rotator Cuff TearsNCT07568392
Arthroscopic Rotator Cuff Repair Trial
A study testing Rotator cuff repair with biceps patch augmentation and Rotator cuff repair without biceps patch augmentation in people with Rotator Cuff Tears, run by Joseph W. Galvin.
Trial summary
This study aims to assess post-operative outcomes and healing rates following arthroscopic rotator cuff repair with and without biceps tendon autograft patch augmentation in patients with medium to large rotator cuff tears. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Rotator cuff repair with biceps patch augmentation and Rotator cuff repair without biceps patch augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age who speak English, indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis.
- Supraspinatus (+/- anterior infraspinatus tendon) full thickness tears.
- Medium (1-3cm) and large (3-5) cm tears. Classification according to anterior to posterior dimensions: small <1cm, medium 1-3 cm, large 3-5 cm, massive >5cm or 2 tendons.
- Patte Grade 1 and 2. Patte Classification: grade 1, tear at insertion; grade 2, retracted to humeral head; grade 3, retracted to glenoid or medial to glenoid.
- Goutallier grade 0-2 fatty infiltration on pre-operative MRI.
- Repairable upper border subscapularis tendon tear.
- Patients undergoing concomitant biceps tenodesis.
Who cannot join
- Pregnant women, non-English speakers and prisoners.
- Patients with prior surgery on the ipsilateral shoulder.
- Worker's compensation status.
- Adhesive capsulitis.
- Patient with glenohumeral osteoarthritis, as graded by the modified Samilson and Prieto Classification (grades 1-3).
- Partial thickness rotator cuff tears.
- Any cuff tears requiring medialization of the footprint
- Patients undergoing concomitant distal clavicle resection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Arthroscopic Rotator Cuff Repair With and Without Biceps Tendon Autograft Patch Augmentation
This study aims to assess post-operative outcomes and healing rates following arthroscopic rotator cuff repair with and without biceps tendon autograft patch augmentation in patients with medium to large rotator cuff tears. This will be a single center, parallel arm randomized trial within the Orthopedics Shoulder Surgery Department at University of Iowa Hospitals and Clinics (UIHC). Eligible patients indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis will be enrolled, consented and randomized, in a 1:1 scheme, into 2 study arms. Arm 1 will consist of arthroscopic rotator cuff repair without biceps tendon autograft. Arm 2 will consist of arthroscopic rotator cuff repair with biceps tendon autograft patch augmentation. Outcomes of interest are American Shoulder and Elbow Surgeons Score (ASES), at 1 year and 2 years postoperatively. Exploratory outcomes are SANE, VAS Pain and active shoulder range of motion, and healing signs on MRI imaging studies at minimum 6-months postoperatively.
Read the detailed description
Rotator cuff tears are common causes of shoulder pain, and it is a highly prevalent condition among a variety of ages. Treatment options for rotator cuff tears include nonsurgical and surgical options. Surgical repair of rotator cuff tears is a widely accepted treatment option; however, re-tear rates are concerning and a frequent complication. Published studies suggest failure rates ranging from 11-94%. Different surgical techniques have been designed to address this potential complication, such as patch augmentation. Recently, patch augmentation with biceps tendon autograft has been utilized as a cost-effective approach. Therefore, the purpose of this study is to evaluate and compare post-operative outcomes and tendon healing rates after rotator cuff repairs with and without patch augmentation with biceps tendon. This study aims to assess post-operative outcomes and healing rates following arthroscopic rotator cuff repair with and without biceps tendon autograft patch augmentation in patients with medium to large rotator cuff tears. Both surgical techniques are standard of care procedures performed routinely at University of Iowa Health Care. This will be a single center, parallel arm randomized trial within the Orthopedics Shoulder Surgery Department at University of Iowa Hospitals and Clinics (UIHC). Eligible patients indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis will be enrolled, consented and randomized, in a 1:1 scheme, into 2 study arms. Arm 1 will consist of arthroscopic rotator cuff repair without biceps tendon autograft. Arm 2 will consist of arthroscopic rotator cuff repair with biceps tendon autograft. Outcomes of interest are American Shoulder and Elbow Surgeons Score (ASES), at 1 year and 2 years postoperatively. Exploratory outcomes are SANE, VAS Pain and active range of motion, and healing signs on imaging studies at minimum 6-months postoperatively. Participants in both arms will undergo a shoulder MRI without contrast at 6 months post-operatively. This MRI is the same type of MRI perform as diagnosis or control as standard of care practices.
- Conditions
- Rotator Cuff Tears
- Being tested
- Rotator cuff repair with biceps patch augmentation, Rotator cuff repair without biceps patch augmentation
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator cuff repair with biceps patch augmentationProcedure or surgery
This is a standard of care practice surgical technique. This arm will undergo arthroscopic rotator cuff repair with the use of called "Biceps Smash" technique which may provide improved tendon thickness and biology with limited morbidity and in a cost effective approach
Rotator cuff repair without biceps patch augmentationProcedure or surgery
Standard of care technique. Active comparator
| Study group | Role | What they receive |
|---|---|---|
| Cuff repair without patch autograft | Active comparator | Arthroscopic rotator cuff repair without patch augmentation Receives: Procedure: Rotator cuff repair without biceps patch augmentation |
| Cuff repair with patch augmentation | Experimental | Arthroscopic rotator cuff repair with patch augmentation Receives: Procedure: Rotator cuff repair with biceps patch augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASES Score
American Shoulder and Elbow Surgeons Score. From 0-100. Higher is better
Measured: 1 year post-operative
Secondary outcomes (1)
Rotator cuff healing
Signs of cuff healing in MRI
Measured: 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph W. Galvin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph W. Galvin, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568392
- Sponsor's protocol ID
- 202512509
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Arthroscopic Rotator Cuff Repair With and Without Biceps Tendon Autograft Patch Augmentation
- ClinicalTrials.gov ID
- NCT07568392
- Acronym / sponsor ID
- 202512509
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Joseph W. GalvinUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- 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.
This study aims to assess post-operative outcomes and healing rates following arthroscopic rotator cuff repair with and without biceps tendon autograft patch augmentation in patients with medium to large rotator cuff tears. This will be a single center, parallel arm randomized trial within the Orthopedics Shoulder Surgery Department at University of Iowa Hospitals and Clinics (UIHC). Eligible patients indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis will be enrolled, consented and randomized, in a 1:1 scheme, into 2 study arms. Arm 1 will consist of arthroscopic rotator cuff repair without biceps tendon autograft. Arm 2 will consist of arthroscopic rotator cuff repair with biceps tendon autograft patch augmentation. Outcomes of interest are American Shoulder and Elbow Surgeons Score (ASES), at 1 year and 2 years postoperatively. Exploratory outcomes are SANE, VAS Pain and active shoulder range of motion, and healing signs on MRI imaging studies at minimum 6-months postoperatively.
Detailed description
Rotator cuff tears are common causes of shoulder pain, and it is a highly prevalent condition among a variety of ages. Treatment options for rotator cuff tears include nonsurgical and surgical options. Surgical repair of rotator cuff tears is a widely accepted treatment option; however, re-tear rates are concerning and a frequent complication. Published studies suggest failure rates ranging from 11-94%. Different surgical techniques have been designed to address this potential complication, such as patch augmentation. Recently, patch augmentation with biceps tendon autograft has been utilized as a cost-effective approach. Therefore, the purpose of this study is to evaluate and compare post-operative outcomes and tendon healing rates after rotator cuff repairs with and without patch augmentation with biceps tendon. This study aims to assess post-operative outcomes and healing rates following arthroscopic rotator cuff repair with and without biceps tendon autograft patch augmentation in patients with medium to large rotator cuff tears. Both surgical techniques are standard of care procedures performed routinely at University of Iowa Health Care. This will be a single center, parallel arm randomized trial within the Orthopedics Shoulder Surgery Department at University of Iowa Hospitals and Clinics (UIHC). Eligible patients indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis will be enrolled, consented and randomized, in a 1:1 scheme, into 2 study arms. Arm 1 will consist of arthroscopic rotator cuff repair without biceps tendon autograft. Arm 2 will consist of arthroscopic rotator cuff repair with biceps tendon autograft. Outcomes of interest are American Shoulder and Elbow Surgeons Score (ASES), at 1 year and 2 years postoperatively. Exploratory outcomes are SANE, VAS Pain and active range of motion, and healing signs on imaging studies at minimum 6-months postoperatively. Participants in both arms will undergo a shoulder MRI without contrast at 6 months post-operatively. This MRI is the same type of MRI perform as diagnosis or control as standard of care practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cuff repair without patch autograft | Active comparator | Procedure: Rotator cuff repair without biceps patch augmentationArthroscopic rotator cuff repair without patch augmentation |
| Cuff repair with patch augmentation | Experimental | Procedure: Rotator cuff repair with biceps patch augmentationArthroscopic rotator cuff repair with patch augmentation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients > 18 years of age who speak English, indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis.
- Supraspinatus (+/- anterior infraspinatus tendon) full thickness tears.
- Medium (1-3cm) and large (3-5) cm tears. Classification according to anterior to posterior dimensions: small <1cm, medium 1-3 cm, large 3-5 cm, massive >5cm or 2 tendons.
- Patte Grade 1 and 2. Patte Classification: grade 1, tear at insertion; grade 2, retracted to humeral head; grade 3, retracted to glenoid or medial to glenoid.
- Goutallier grade 0-2 fatty infiltration on pre-operative MRI.
Key exclusion criteria (8 listed)
- Pregnant women, non-English speakers and prisoners.
- Patients with prior surgery on the ipsilateral shoulder.
- Worker's compensation status.
- Adhesive capsulitis.
- Patient with glenohumeral osteoarthritis, as graded by the modified Samilson and Prieto Classification (grades 1-3).
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 |
|---|---|---|
| Rotator cuff repair with biceps patch augmentationThis is a standard of care practice surgical technique. This arm will undergo arthroscopic rotator cuff repair with the use of called "Biceps Smash" technique which may provide improved tendon thickness and biology with limited morbidity and in a cost effective approach | Procedure or surgery | Cuff repair with patch augmentation |
| Rotator cuff repair without biceps patch augmentationStandard of care technique. Active comparator | Procedure or surgery | Cuff repair without patch autograft |
Primary outcome
ASES Score
Time frame: 1 year post-operative
American Shoulder and Elbow Surgeons Score. From 0-100. Higher is better
1 secondary outcome
Rotator cuff healing
Time frame: 6 months post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Rotator cuff repair with biceps patch augmentation and Rotator cuff repair without biceps patch augmentation in people with Rotator Cuff Tears, run by Joseph W. Galvin.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Galvin, Other, MD (3193848378, joseph-galvin@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES Score (time frame: 1 year post-operative). 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 5 May 2026.