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Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears (ARC)

Primary Purpose

Rotator Cuff Tear

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Operative
Non-Operative
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring arthroscopy, physical therapy, rehabilitation, surgery, rotator cuff tear

Eligibility Criteria

40 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University of California - San Francisco (UCSF)Recruiting
  • Western OrthopaedicsRecruiting
  • University of Colorado - DenverRecruiting
  • University of Iowa
  • University of Kentucky
  • Johns HopkinsRecruiting
  • Boston Medical CenterRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • University of MichiganRecruiting
  • Washington UniversityRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • University of Pennsylvania
  • Rothman Orthopaedic Institute
  • Medical University of South CarolinaRecruiting
  • Orthopedic InstituteRecruiting
  • Ortho Tennessee - Knoxville Orthopedic ClinicRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • University of Texas SouthwesternRecruiting
  • Ortho VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Operative

Non-Operative

Arm Description

surgery + post-operative physical therapy

non-operative physical therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 22, 2017
Last Updated
September 5, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Patient-Centered Outcomes Research Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT03295994
Brief Title
Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
Acronym
ARC
Official Title
Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Patient-Centered Outcomes Research Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
arthroscopy, physical therapy, rehabilitation, surgery, rotator cuff tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Operative
Arm Type
Active Comparator
Arm Description
surgery + post-operative physical therapy
Arm Title
Non-Operative
Arm Type
Active Comparator
Arm Description
non-operative physical therapy
Intervention Type
Procedure
Intervention Name(s)
Operative
Intervention Description
Arthroscopic rotator cuff surgery followed by physical therapy.
Intervention Type
Procedure
Intervention Name(s)
Non-Operative
Intervention Description
Physical therapy (without surgery).
Primary Outcome Measure Information:
Title
Shoulder Pain & Disability Index (SPADI)
Description
SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst.
Time Frame
Study participants will be followed for 12 months
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons (ASES)
Description
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.
Time Frame
Study participants will be followed for 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hemangi Dhole, MPH
Phone
2146450059
Email
hemangi.dhole@utsouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Newman, PhD
Phone
2146486736
Email
mark.newman@UTSouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitin Jain, MD,MSPH
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California - San Francisco (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyn Carpio
Phone
415-502-7389
Email
jocelyn.carpio@ucsf.edu
First Name & Middle Initial & Last Name & Degree
C. Benjamin Ma, MD
Facility Name
Western Orthopaedics
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Libby Mauter
Phone
303-321-1333
Email
LMauter@Western-Ortho.com
First Name & Middle Initial & Last Name & Degree
Mallory Boyd
Phone
303-321-1333
Ext
7423
Email
MBoyd@western-ortho.com
First Name & Middle Initial & Last Name & Degree
Armand Hatzidakis, MD
Facility Name
University of Colorado - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andres Barandiaran
Phone
303-724-3917
Email
andres.barandiaran@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Eric McCarty, MD
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arman Kishan
Email
akishan1@jh.edu
First Name & Middle Initial & Last Name & Degree
Uma Srikumaran, MD
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayson Saleet
Email
jsaleet@bu.edu
First Name & Middle Initial & Last Name & Degree
Xinning Li, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katiri Wagner-Nunes, CCRC
Phone
617-975-7577
Email
kwagner@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Joseph DeAngelis, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Mills
Phone
734-615-0768
Email
millsrya@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Bruce S. Miller, MD, MS
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Braun, MA
Phone
314-362-3768
Email
haasa@wudosis.wustl.edu
First Name & Middle Initial & Last Name & Degree
Wendy Holloway
Phone
314-747-2492
Email
hollowayw@wudosis.wustl.edu
First Name & Middle Initial & Last Name & Degree
Matthew V. Smith, MD, MSc
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Keller
Phone
614-293-2410
Email
michael.keller@osumc.edu
First Name & Middle Initial & Last Name & Degree
Gregory Cvetanovich, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Mock, CCRC
Phone
843-876-2211
Email
mockl@musc.edu
First Name & Middle Initial & Last Name & Degree
Josef K Eichinger, MD
Facility Name
Orthopedic Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khris Loe
Phone
888-331-5890
Email
kloe@ortho-i.com
First Name & Middle Initial & Last Name & Degree
Keith M Baumgarten, MD
Facility Name
Ortho Tennessee - Knoxville Orthopedic Clinic
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grayson Poff
Phone
615-772-8819
Email
grayson.poff@orthotennessee.com
First Name & Middle Initial & Last Name & Degree
Edwin E. Spencer, Jr., MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flora Suazo
Phone
615-936-8946
Email
flora.m.suazo@vumc.org
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hemangi Dhole, MPH
Phone
214-645-0059
Email
hemangi.dhole@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Mark Newman, PhD
Phone
214-648-6736
Email
mark.newman@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Nitin B. Jain, MD, MSPH
Facility Name
Ortho Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Werth
Email
Paul.Werth@orthovirginia.com
First Name & Middle Initial & Last Name & Degree
Andrew Neviaser, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31397866
Citation
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.
Results Reference
derived
Links:
URL
https://shoulderstudy.org/studies/arc-trial/
Description
ARC Trial website

Learn more about this trial

Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears

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