Arthroscopic Rotator Cuff Repair Trial

April 30, 2026 updated by: Joseph W. Galvin

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cuff repair without patch autograft
Arthroscopic rotator cuff repair without patch augmentation
Procedure: Rotator cuff repair without biceps patch augmentation
Standard of care technique. Active comparator
Experimental: Cuff repair with patch augmentation
Arthroscopic rotator cuff repair with patch augmentation
Procedure: Rotator cuff repair with biceps patch augmentation
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ASES Score
Time Frame: 1 year post-operative
American Shoulder and Elbow Surgeons Score. From 0-100. Higher is better
1 year post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rotator cuff healing
Time Frame: 6 months post-operative
Signs of cuff healing in MRI
6 months post-operative

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SANE Score
Time Frame: 1 year post-operative
From 0-100, how good the shoulder feels. Higher is better
1 year post-operative
VAS Pain Score
Time Frame: 1 year post-operative
0-10. Higher is worse
1 year post-operative
ROM
Time Frame: 1 year post-operative
Range of motion
1 year post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joseph W. Galvin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202512509

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings