NCT04742452

Brief Summary

The primary objective of this prospective randomized controlled trial is to compare pain and functional outcomes between two surgical modalities for irreparable rotator cuff tears as measured by the pain visual analog scale (VAS), simple shoulder test (SST), American Shoulder and Elbow Surgery shoulder score (ASES), and Patient Reported Outcomes Measurement Information System (PROMIS) 29 score at 6 weeks, 3, 6, 12, and 24 months post-operatively. The two surgical modalities of interest are partial rotator cuff repair alone and partial rotator cuff repair with superior capsule reconstruction (SCR). The secondary objective of this study is determine the failure rate of partial repair alone vs. partial repair with SCR via magnetic resonance imaging (MRI) at 12 months post-operatively. The information gained from this investigation will be useful to discern if SCR provides any benefit to patients with irreparable rotator cuff tears. The investigators hypothesize that there is no statistically significant difference in pain and functional outcomes between partial rotator cuff repair alone versus partial rotator cuff repair with SCR. In addition, the investigators hypothesize that the failure rate will be significantly higher in patients undergoing partial rotator cuff repair with SCR.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Nov 2020Jun 2026

Study Start

First participant enrolled

November 24, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

5.5 years

First QC Date

December 10, 2020

Last Update Submit

February 9, 2026

Conditions

Rotator Cuff Tears

Keywords

Superior capsular reconstructionPartial rotator cuff repairMagnetic resonance imaging

Outcome Measures

Primary Outcomes (20)

  • Pain Visual Analog Scale (VAS)

    Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain

    6 weeks

  • Pain Visual Analog Scale (VAS)

    Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain

    3 months

  • Pain Visual Analog Scale (VAS)

    Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain

    6 months

  • Pain Visual Analog Scale (VAS)

    Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain

    12 months

  • Pain Visual Analog Scale (VAS)

    Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain

    24 months

  • American Shoulder and Elbow Society (ASES) score

    Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.

    6 weeks

  • American Shoulder and Elbow Society (ASES) score

    Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.

    3 months

  • American Shoulder and Elbow Society (ASES) score

    Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.

    6 months

  • American Shoulder and Elbow Society (ASES) score

    Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.

    12 months

  • American Shoulder and Elbow Society (ASES) score

    Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.

    24 months

  • Simple Shoulder Test (SST)

    Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.

    6 weeks

  • Simple Shoulder Test (SST)

    Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.

    3 months

  • Simple Shoulder Test (SST)

    Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.

    6 months

  • Simple Shoulder Test (SST)

    Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.

    12 months

  • Simple Shoulder Test (SST)

    Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.

    24 months

  • Patient Reported Outcomes Measurement Information Systems (PROMIS)-29

    29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.

    6 weeks

  • Patient Reported Outcomes Measurement Information Systems (PROMIS)-29

    29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.

    3 months

  • Patient Reported Outcomes Measurement Information Systems (PROMIS)-29

    29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.

    6 months

  • Patient Reported Outcomes Measurement Information Systems (PROMIS)-29

    29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.

    12 months

  • Patient Reported Outcomes Measurement Information Systems (PROMIS)-29

    29 question form. Scores range from 0 to 100. Higher scores correspond with better outcomes. Questions assess physical function, anxiety, depression, fatigue, pain interference, sleep quality, and social activity.

    24 months

Secondary Outcomes (1)

  • Graft/repair integrity via magnetic resonance imaging

    12-months post-operatively.

Study Arms (2)

Superior Capsular Reconstruction

ACTIVE COMPARATOR
Procedure: Superior Capusular Reconstruction

Partial Rotator Cuff Repair

PLACEBO COMPARATOR
Procedure: Partial Rotator Cuff Repair

Interventions

Superior Capusular ReconstructionPROCEDURE

Superior capsular reconstruction is one treatment option for massive and irreparable rotator cuff tears. The superior shoulder capsule, a thin membranous structure located on the inferior surface of the supraspinatus and infraspinatus muscles, is often torn in this type of rotator cuff tear. In superior capsular reconstruction, this structure is reconstructed with acellular dermal allograft.

Superior Capsular Reconstruction
Partial Rotator Cuff RepairPROCEDURE

Partial rotator cuff repair can be performed, in conjunction with other procedures such as subacromial decompression and biceps tenodesis, when a rotator cuff tear is not amenable to a complete repair.

Partial Rotator Cuff Repair

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range: ≥18 years
  • Irreparable rotator cuff tear suspected on pre-operative MRI

You may not qualify if:

  • Pregnant, illiterate, or non-English speaking individuals
  • Rotator cuff pathology amenable to a complete repair intraoperatively
  • Moderate to severe rotator cuff arthropathy (Hamada grade ≥3)
  • Presence of glenohumeral arthritis on radiographs
  • Irreparable subscapularis muscle intraoperatively
  • Active infection within the ipsilateral glenohumeral joint
  • Neurologic pathology limiting shoulder function
  • Current smoker
  • Workers' compensation claim

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Midwest Orthopaedics at Rush

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Lake Health

Willoughby, Ohio, 44094, United States

RECRUITING

Related Publications (6)

  • Bedi A, Dines J, Warren RF, Dines DM. Massive tears of the rotator cuff. J Bone Joint Surg Am. 2010 Aug 4;92(9):1894-908. doi: 10.2106/JBJS.I.01531.

    PMID: 20686065BACKGROUND

  • Carver TJ, Kraeutler MJ, Smith JR, Bravman JT, McCarty EC. Nonarthroplasty Surgical Treatment Options for Massive, Irreparable Rotator Cuff Tears. Orthop J Sports Med. 2018 Nov 7;6(11):2325967118805385. doi: 10.1177/2325967118805385. eCollection 2018 Nov.

    PMID: 30480007BACKGROUND

  • Cvetanovich GL, Waterman BR, Verma NN, Romeo AA. Management of the Irreparable Rotator Cuff Tear. J Am Acad Orthop Surg. 2019 Dec 15;27(24):909-917. doi: 10.5435/JAAOS-D-18-00199.

    PMID: 31206436BACKGROUND

  • Walch G, Edwards TB, Boulahia A, Nove-Josserand L, Neyton L, Szabo I. Arthroscopic tenotomy of the long head of the biceps in the treatment of rotator cuff tears: clinical and radiographic results of 307 cases. J Shoulder Elbow Surg. 2005 May-Jun;14(3):238-46. doi: 10.1016/j.jse.2004.07.008.

    PMID: 15889020BACKGROUND

  • Denard PJ, Brady PC, Adams CR, Tokish JM, Burkhart SS. Preliminary Results of Arthroscopic Superior Capsule Reconstruction with Dermal Allograft. Arthroscopy. 2018 Jan;34(1):93-99. doi: 10.1016/j.arthro.2017.08.265. Epub 2017 Nov 13.

    PMID: 29146165BACKGROUND

  • Mihata T, Lee TQ, Watanabe C, Fukunishi K, Ohue M, Tsujimura T, Kinoshita M. Clinical results of arthroscopic superior capsule reconstruction for irreparable rotator cuff tears. Arthroscopy. 2013 Mar;29(3):459-70. doi: 10.1016/j.arthro.2012.10.022. Epub 2013 Jan 28.

    PMID: 23369443BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Central Study Contacts

John T Strony, BS

CONTACT

908-268-3663john.strony@uhhospitals.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Shoulder and Elbow Surgery, UH Cleveland Medical Center Program Director, Orthopaedic Surgery, UH Cleveland Medical Center Associate Professor, CWRU School of Medicine

Study Record Dates

First Submitted

December 10, 2020

First Posted

February 8, 2021

Study Start

November 24, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations

US(3)