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Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears

Primary Purpose

Rotator Cuff Tears

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Superior Capusular Reconstruction
Partial Rotator Cuff Repair
Sponsored by
Robert J. Gillespie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Superior capsular reconstruction, Partial rotator cuff repair, Magnetic resonance imaging

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Midwest Orthopaedics at Rush
  • University Hospitals Cleveland Medical CenterRecruiting
  • Lake HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Superior Capsular Reconstruction

Partial Rotator Cuff Repair

Arm Description

Outcomes

Primary Outcome Measures

Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Pain Visual Analog Scale (VAS)
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
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.
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.
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.
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.
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.
Simple Shoulder Test (SST)
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Simple Shoulder Test (SST)
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Simple Shoulder Test (SST)
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Simple Shoulder Test (SST)
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Simple Shoulder Test (SST)
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Graft/repair integrity via magnetic resonance imaging
Assessing the integrity of the repair, either SCR or the partial repair, to see if it is still intact at 12 months post-operatively.

Full Information

First Posted
December 10, 2020
Last Updated
November 28, 2022
Sponsor
Robert J. Gillespie
Collaborators
University Hospitals Cleveland Medical Center, Lake Health, Midwest Orthopaedics at Rush
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1. Study Identification

Unique Protocol Identification Number
NCT04742452
Brief Title
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
Official Title
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert J. Gillespie
Collaborators
University Hospitals Cleveland Medical Center, Lake Health, Midwest Orthopaedics at Rush

4. Oversight

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

5. Study Description

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.
Detailed Description
Rotator cuff injury is a commonly encountered problem within the United States. In most cases, surgical repair can reduce pain and restore baseline functional status. However, in the case of an irreparable rotator cuff tear, management becomes more challenging as these injuries tend to be larger in size, are inelastic secondary to tendon retraction, and exhibit fatty infiltration and rotator cuff atrophy1. A multitude of surgical approaches for an irreparable rotator cuff tear have been described in the literature, including partial repair alone, partial repair with superior capsular reconstruction (SCR), arthroscopic debridement, graft interposition, balloon spacer arthroplasty, tendon transfers, and reverse total shoulder arthroplasty (rTSA)2. In younger patients, the traditional approach to managing these injuries involved partial rotator cuff repair with subacromial decompression and debridement with the hopes of providing the patient with some restoration of function and pain relief3,4. Clinical studies have demonstrated that partial repair can lead to an improvement in pain and function in the early post-operative period; long-term outcomes following this procedure were less reliable3. In addition, a high rate of failure has been associated with partial rotator cuff repair alone. Partial repair with SCR is a relatively new surgical procedure that has become an increasingly popular treatment modality in recent years because of early promising biomechanical and functional outcomes5,6. However, there have been no prospective randomized assessments of SCR. Therefore, the long-term outcomes of SCR compared to the standard of care, namely partial rotator cuff repair, are unknown. This will be a multi-center, prospective randomized controlled trial. Prior to enrollment, patients will be screened for inclusion criteria. Participants who meet the eligibility criteria and are suspected to have an irreparable rotator cuff tear will be randomized into one of the two treatment arms prior to surgery. Group 1 will receive partial rotator cuff repair alone while group 2 will receive partial rotator cuff repair with SCR. All patients with suspected irreparable rotator cuff tears will be consented in clinic. There is the potential situation where the surgeon believed that the rotator cuff tear was irreparable based on clinical and radiographic evidence but was able to completely repair the tear intraoperatively. Based on the modified intention-to-treat (mITT) principle, these select patients will be dropped from the study and will no longer be followed for research purposes. Randomization will occur with a stratified randomization excel spreadsheet. Each group will be followed post-operatively for 24 months. The primary objective of this study is to compare pain and functional outcomes between the two treatment arms. The secondary objective is to assess the failure rate between the two treatment arms. Study Procedures All patients with a strongly suspected irreparable rotator cuff tear will be identified in the clinics of the treating physicians and be screened for inclusion and exclusion criteria. The consent form will be reviewed in depth with the patients by an IRB-approved member of the study team, and all questions will be answered prior to enrollment in the study. Patients will be asked if they need additional time to review the consent, and no coercion will occur throughout the consent process. Although patients will be consented at this clinic visit, they will be informed that there is a possibility that they will ultimately be excluded from the study because an irreparable rotator cuff tear can only be confirmed intraoperatively. At the initial pre-operative clinic visit, patient demographics will be collected and the pain and functional status of patients will be assessed using VAS, SST, ASES, and PROMIS-29 scores. It should take approximately 15 minutes to complete these surveys in clinic. Patients requiring medical clearance to ensure their health is optimized for surgery will do so. After receiving medical clearance (if needed), the patients will undergo surgery. Patients will be randomized prior to surgery into one of two possible treatment arms as described above. Stratified randomization will be performed with Microsoft Excel. If a patient, who was suspected to have an irreparable rotator cuff tear based on clinical and radiographic findings, is amenable to a complete rotator cuff tear, they will be dropped from the study and no longer followed for research purposes. This is based on the mITT principle. On the day of surgery, the patient will receive either a partial rotator cuff repair alone or a partial rotator cuff repair with SCR. Intraoperative data will be collected. For both groups, the investigators will assess if the following were performed during the procedure: subacromial decompression, biceps tenotomy vs. tenodesis, marginal convergence, single vs. double-row repair, and repair of the subscapularis muscle. For the SCR group, the size (mm2) and width (mm) of the acellular dermal allograft will be recorded. Finally, any complications that occur intraoperatively will be recorded for both groups. After discharge from the surgery center, both groups of patients will be given identical pain medication regimens, post-operative restrictions, and clinical follow-up schedule. They will be instructed to follow-up in clinic at 6 weeks, 3, 6, 12, and 24 months post-operatively. At each post-operative appointment, the patients will again be administered the VAS, SST, ASES, and PROMIS-29 questionnaires. Complications will be assessed at each visit. In addition, at the 12-month follow-up appointment, each patient in both groups will be given a prescription for an MRI of the operative shoulder to assess for failure of the repair. Key variables for analysis will be found within the electronic medical record, and in questionnaires administered at clinic appointments. They include: age at time of surgery, sex, height, weight, hand dominance, laterality of surgery, mechanism of injury, and surgical complications (e.g., infection, failure of repair).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
Superior capsular reconstruction, Partial rotator cuff repair, Magnetic resonance imaging

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Superior Capsular Reconstruction
Arm Type
Active Comparator
Arm Title
Partial Rotator Cuff Repair
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Superior Capusular Reconstruction
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Partial Rotator Cuff Repair
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Visual Analog Scale (VAS)
Description
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Time Frame
6 weeks
Title
Pain Visual Analog Scale (VAS)
Description
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Time Frame
3 months
Title
Pain Visual Analog Scale (VAS)
Description
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Time Frame
6 months
Title
Pain Visual Analog Scale (VAS)
Description
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Time Frame
12 months
Title
Pain Visual Analog Scale (VAS)
Description
Scale of 0 to 10; 0 is no pain, 10 is the most amount of pain
Time Frame
24 months
Title
American Shoulder and Elbow Society (ASES) score
Description
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
Time Frame
6 weeks
Title
American Shoulder and Elbow Society (ASES) score
Description
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
Time Frame
3 months
Title
American Shoulder and Elbow Society (ASES) score
Description
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
Time Frame
6 months
Title
American Shoulder and Elbow Society (ASES) score
Description
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
Time Frame
12 months
Title
American Shoulder and Elbow Society (ASES) score
Description
Minimum score is 0, Maximum score is 100; 50% weighted for pain, 50% weighted for function. The higher the number the better the outcome.
Time Frame
24 months
Title
Simple Shoulder Test (SST)
Description
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Time Frame
6 weeks
Title
Simple Shoulder Test (SST)
Description
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Time Frame
3 months
Title
Simple Shoulder Test (SST)
Description
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Time Frame
6 months
Title
Simple Shoulder Test (SST)
Description
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Time Frame
12 months
Title
Simple Shoulder Test (SST)
Description
Minimum score is 0%, maximum is 100%. 12 yes/no questions. Higher scores correspond with better outcomes.
Time Frame
24 months
Title
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
Description
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.
Time Frame
6 weeks
Title
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
Description
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.
Time Frame
3 months
Title
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
Description
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.
Time Frame
6 months
Title
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
Description
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.
Time Frame
12 months
Title
Patient Reported Outcomes Measurement Information Systems (PROMIS)-29
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Graft/repair integrity via magnetic resonance imaging
Description
Assessing the integrity of the repair, either SCR or the partial repair, to see if it is still intact at 12 months post-operatively.
Time Frame
12-months post-operatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age range: ≥18 years Irreparable rotator cuff tear suspected on pre-operative MRI Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John T Strony, BS
Phone
908-268-3663
Email
john.strony@uhhospitals.org
Facility Information:
Facility Name
Midwest Orthopaedics at Rush
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grant Garrigues, MD
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Strony, BS
Phone
908-268-3663
Email
john.strony@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Robert Gillespie, MD
Facility Name
Lake Health
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Parsons, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20686065
Citation
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.
Results Reference
background
PubMed Identifier
30480007
Citation
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.
Results Reference
background
PubMed Identifier
31206436
Citation
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.
Results Reference
background
PubMed Identifier
15889020
Citation
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.
Results Reference
background
PubMed Identifier
29146165
Citation
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.
Results Reference
background
PubMed Identifier
23369443
Citation
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.
Results Reference
background

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Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears

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