Rotator Cuff TearARCNCT03295994
Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
A study testing Arthroscopic Rotator Cuff Surgery and Physical Therapy in people with Rotator Cuff Tear, run by University of Michigan at 19 sites in United States.
Trial summary
Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed. Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Arthroscopic Rotator Cuff Surgery and Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 19 sitesUnited States
- Study dates
- 19 Mar 2018to 28 Feb 2025
- 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 40 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged =>40 years to <85 years
- Shoulder pain and/or loss of range of active motion, strength or function
- MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension
- Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification
- Ability and willingness to provide informed consent
Who cannot join
- Primary diagnosis is something other than a rotator cuff tear
- History (in last 2 years) of shoulder fracture involving the humeral head on affected side
- Previous rotator cuff surgery on affected side
- Isolated subscapularis \&/or teres minor tear on affected side
- Acute rotator cuff tear caused by a severe trauma
- Shoulder used as a weight-bearing joint
Show all 12Show fewer
- Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)
- Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD
- Grade 4 fatty infiltration of rotator cuff (any tendons)
- Candidate for shoulder arthroplasty at baseline
- Non-English speaking
- Severe problems with maintaining follow-up expected (such as, but not limited to, history of substance abuse, homelessness/incarceration, dementia, brain injury, and psychotic disorders)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University of Michigan
Ann Arbor, Michigan, 48106
Johns Hopkins
Baltimore, Maryland, 21218
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43202
University of Texas Southwestern
Dallas, Texas, 75390
Western Orthopaedics
Denver, Colorado, 80218
University of Colorado - Denver
Denver, Colorado, 80222
University of Iowa
Iowa City, Iowa, 52242
Ortho Tennessee - Knoxville Orthopedic Clinic
Knoxville, Tennessee, 37922
University of Kentucky
Lexington, Kentucky, 40536
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Phoenix, Arizona, 85054
Ortho Virginia
Richmond, Virginia, 23294
University of California - San Francisco (UCSF)
San Francisco, California, 94158
Orthopedic Institute
Sioux Falls, South Dakota, 57105
Washington University
St Louis, Missouri, 63110
About this study
Official title: Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial
Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.
Read the detailed description
This is non-blinded, randomized controlled trial. Patients will be randomly assigned to either an operative or non-operative course of treatment and will be followed for 12 months from baseline.
Aim 1: To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up
Aim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears
5U34AR069201-02 NIH grant funded the preparatory work for the trial but not the trial itself.
- Conditions
- Rotator Cuff Tear
- Being tested
- Arthroscopic Rotator Cuff Surgery, Physical Therapy
- Keywords
- arthroscopy, physical therapy, rehabilitation, surgery, rotator cuff tear
- 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.
Arthroscopic Rotator Cuff SurgeryProcedure or surgery
Arthroscopic rotator cuff surgery
Physical TherapyProcedure or surgery
Physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Operative | Active comparator | surgery + post-operative physical therapy Receives: Procedure: Arthroscopic Rotator Cuff Surgery; Procedure: Physical Therapy |
| Non-Operative | Active comparator | non-operative physical therapy Receives: Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain & Disability Index (SPADI)
SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst.
Measured: Study participants will be followed for 12 months
Secondary outcomes (1)
American Shoulder and Elbow Surgeons (ASES)
ASES is a pain and activity of daily living questionnaire. The range is from 0 to 100, with 0 being worst, and 100 being best.
Measured: Study participants will be followed for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start19 Mar 2018
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Nitin Jain, University of Michigan
- Investigators
- Nitin B Jain, MD,MSPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295994
- Sponsor's protocol ID
- 171863
- Other IDs
- 1605-35413, U34AR069201
- Acronym
- ARC
- Status last verified
- Mar 2026
- First submitted
- 22 Sep 2017
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jain NB, Ayers GD, Koudelkova H, Archer KR, Dickinson R, Richardson B, Derryberry M, Kuhn JE; ARC Trial Group. Operative vs Nonoperative Treatment for Atraumatic Rotator Cuff Tears: A Trial Protocol for the Arthroscopic Rotator Cuff Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199050. doi: 10.1001/jamanetworkopen.2019.9050.
PubMed 31397866
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial
- ClinicalTrials.gov ID
- NCT03295994
- Acronym / sponsor ID
- ARC / 171863
- Conditions
- Rotator Cuff Tear
- Keywords
- arthroscopy, physical therapy, rehabilitation, surgery, rotator cuff tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 28 Sep 2017 (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.
Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.
Detailed description
This is non-blinded, randomized controlled trial. Patients will be randomly assigned to either an operative or non-operative course of treatment and will be followed for 12 months from baseline.
Aim 1: To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up
Aim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears
5U34AR069201-02 NIH grant funded the preparatory work for the trial but not the trial itself.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative | Active comparator | Procedure: Arthroscopic Rotator Cuff Surgery, Procedure: Physical Therapysurgery + post-operative physical therapy |
| Non-Operative | Active comparator | Procedure: Physical Therapynon-operative physical therapy |
Who may qualify
- Ages
- 40 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged =>40 years to <85 years
- Shoulder pain and/or loss of range of active motion, strength or function
- MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension
- Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification
- Ability and willingness to provide informed consent
Key exclusion criteria (12 listed)
- Primary diagnosis is something other than a rotator cuff tear
- History (in last 2 years) of shoulder fracture involving the humeral head on affected side
- Previous rotator cuff surgery on affected side
- Isolated subscapularis \&/or teres minor tear on affected side
- Acute rotator cuff tear caused by a severe trauma
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 |
|---|---|---|
| Arthroscopic Rotator Cuff SurgeryArthroscopic rotator cuff surgery | Procedure or surgery | Operative |
| Physical TherapyPhysical therapy | Procedure or surgery | Non-Operative, Operative |
Primary outcome
Shoulder Pain & Disability Index (SPADI)
Time frame: Study participants will be followed for 12 months
SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst.
1 secondary outcome
American Shoulder and Elbow Surgeons (ASES)
Time frame: Study participants will be followed for 12 months
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 30 Mar 2026.
- Derived from this study: PubMed 31397866Jain NB, Ayers GD, Koudelkova H, Archer KR, Dickinson R, Richardson B, Derryberry M, Kuhn JE; ARC Trial Group. Operative vs Nonoperative Treatment for Atraumatic Rotator Cuff Tears: A Trial Protocol for the Arthroscopic Rotator Cuff Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199050. doi: 10.1001/jamanetworkopen.2019.9050.
- ARC Trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nitin B Jain, MD,MSPH principal investigator
University of Michigan
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Rotator Cuff Surgery and Physical Therapy in people with Rotator Cuff Tear, run by University of Michigan at 19 sites 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 5 inclusion and 12 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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?
Shoulder Pain & Disability Index (SPADI) (time frame: Study participants will be followed for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03295994, which also lists 1 linked publication.
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 Mar 2026.