Back to resultsSubscapularis Repair in Reverse Shoulder Arthroplasty (Subscap)
Primary Purpose
Rotator Cuff Tear Arthropathy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repair of the subscapularis
Sponsored by
About this trial
This is an interventional basic science trial for Rotator Cuff Tear Arthropathy
Eligibility Criteria
Inclusion Criteria:
- Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
- Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
- Patient meets FDA cleared indications for reverse shoulder arthroplasty
- Patient is between 18-100 years old
- Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
- Patient has a standard of care pre-operative CT taken within 6 months that has been submitted for Arthrex Virtual Implant Positioning TM (VIP) planning
Exclusion Criteria:
- Patient has a history of ipsilateral shoulder arthroplasty
- A history of shoulder septic arthritis
- A full thickness subscapularis tear
- An acute or malunited proximal humeral fracture
- Chronic locked dislocation
- Rheumatoid arthritis
- Tumors
- Axillary nerve damage
- Non-functioning deltoid muscle
- Glenoid vault deficiency precluding baseplate fixation
- Infection and neuropathic joints
- Known or suspected non-compliance, drug or alcohol abuse
- Patients incapable of judgement or under tutelage
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
- The subject is related to investigator as family members, employees, or other dependent persons
- Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)
Sites / Locations
- The University of Arizona/Banner HealthRecruiting
- Southern Oregon OrthopedicsRecruiting
- The Hawkins FoundationRecruiting
- The Campbell ClinicRecruiting
- Jordan Young InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Reverse Shoulder Arthroplasty with subscapularis repair
Reverse Shoulder Arthroplasty without subscapularis repair
Arm Description
The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.
The subscapularis will not be repaired.
Outcomes
Primary Outcome Measures
Constant-Murley Shoulder Outcome Score
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Constant-Murley Shoulder Outcome Score
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Constant-Murley Shoulder Outcome Score
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Constant-Murley Shoulder Outcome Score
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Constant-Murley Shoulder Outcome Score
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Secondary Outcome Measures
Ultrasound
Evaluation of the subscapularis complex in patients that have been randomized to "repair of the subscapularis" to examine the subscapularis complex. Ultrasound scans will be read and the integrity of the subscapularis complex will be determined by the clinician to be "intact", "attenuated", "partial tear" or "complete tear".
American Shoulder and Elbow Surgeons (ASES) subjective survey
A combination of objective measures and patient-reported outcomes, it measures pain and functional limitations in the shoulder. The objective questionnaire allows documentation of range of motion in the patient.
Simple Shoulder Test (SST) questionnaire
Provides a standardized way of recording the function of a shoulder before and after treatment.
Visual Analog Scale (VAS)
The standard measure for pain on a 0-10 scale, 10 being the worst.
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
A patient administrated questionnaire for measurement of the quality of life. It provides scores on four domains: 1.) physical symptoms, 2.) sport, recreation, and work, 3.) lifestyle and 4.) emotions.
Veterans Rand 12 Item Health Survey (VR-12)
A self-administered health measure. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score, which provides an important contrast between the respondents' physical and psychological health status.
Single Assessment Numeric Evaluation score (SANE)
Asks patients to rate shoulder pain as a percentage of normal.
Standard Pre-Operative Form
A patient administered form that asks patients to evaluate their expectations of their scheduled Arthroplasty procedure.
Return to Work Form
A patient administered form that asks patients to determine the effect that their shoulder has had on their employment.
Standard Late Postoperative Form
A patient administered form that asks patient to evaluate if their expectations were met regarding their Arthroplasty procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05438914
Brief Title
Subscapularis Repair in Reverse Shoulder Arthroplasty
Acronym
Subscap
Official Title
Subscapularis Repair in Reverse Shoulder Arthroplasty: a Randomized, Controlled, Multicenter, Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
September 14, 2025 (Anticipated)
Study Completion Date
September 14, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arthrex, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).
Detailed Description
The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome will be measured by analysis of Constant scores at two years post-operative.
Secondary objectives are to evaluate pain, function and imaging, between the two groups at each applicable time point.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear Arthropathy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be randomly allocated in a 1:1 ratio, with block sizes of four and six using a randomization sequence.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reverse Shoulder Arthroplasty with subscapularis repair
Arm Type
Experimental
Arm Description
The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.
Arm Title
Reverse Shoulder Arthroplasty without subscapularis repair
Arm Type
No Intervention
Arm Description
The subscapularis will not be repaired.
Intervention Type
Device
Intervention Name(s)
Repair of the subscapularis
Intervention Description
The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.
Primary Outcome Measure Information:
Title
Constant-Murley Shoulder Outcome Score
Description
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Time Frame
Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure.
Title
Constant-Murley Shoulder Outcome Score
Description
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Time Frame
Collected at at 9 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
Title
Constant-Murley Shoulder Outcome Score
Description
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Time Frame
Collected at at the 26 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
Title
Constant-Murley Shoulder Outcome Score
Description
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Time Frame
Collected at at 1 year post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
Title
Constant-Murley Shoulder Outcome Score
Description
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Time Frame
Collected at the 2 year post-op timepoint, and is the primary outcome measure
Secondary Outcome Measure Information:
Title
Ultrasound
Description
Evaluation of the subscapularis complex in patients that have been randomized to "repair of the subscapularis" to examine the subscapularis complex. Ultrasound scans will be read and the integrity of the subscapularis complex will be determined by the clinician to be "intact", "attenuated", "partial tear" or "complete tear".
Time Frame
Collected once at either the 6 month, 1 year or 2 year timepoint.
Title
American Shoulder and Elbow Surgeons (ASES) subjective survey
Description
A combination of objective measures and patient-reported outcomes, it measures pain and functional limitations in the shoulder. The objective questionnaire allows documentation of range of motion in the patient.
Time Frame
Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Title
Simple Shoulder Test (SST) questionnaire
Description
Provides a standardized way of recording the function of a shoulder before and after treatment.
Time Frame
Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Title
Visual Analog Scale (VAS)
Description
The standard measure for pain on a 0-10 scale, 10 being the worst.
Time Frame
Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Title
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Description
A patient administrated questionnaire for measurement of the quality of life. It provides scores on four domains: 1.) physical symptoms, 2.) sport, recreation, and work, 3.) lifestyle and 4.) emotions.
Time Frame
Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Title
Veterans Rand 12 Item Health Survey (VR-12)
Description
A self-administered health measure. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score, which provides an important contrast between the respondents' physical and psychological health status.
Time Frame
Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Title
Single Assessment Numeric Evaluation score (SANE)
Description
Asks patients to rate shoulder pain as a percentage of normal.
Time Frame
Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Title
Standard Pre-Operative Form
Description
A patient administered form that asks patients to evaluate their expectations of their scheduled Arthroplasty procedure.
Time Frame
Collected at the pre-op visit.
Title
Return to Work Form
Description
A patient administered form that asks patients to determine the effect that their shoulder has had on their employment.
Time Frame
Collected at pre-op, 26 weeks and 1 year.
Title
Standard Late Postoperative Form
Description
A patient administered form that asks patient to evaluate if their expectations were met regarding their Arthroplasty procedure.
Time Frame
Collected at the 1 year and 2 year timepoints.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
Patient meets FDA cleared indications for reverse shoulder arthroplasty
Patient is between 18-100 years old
Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
Patient has a standard of care pre-operative CT taken within 6 months that has been submitted for Arthrex Virtual Implant Positioning TM (VIP) planning
Exclusion Criteria:
Patient has a history of ipsilateral shoulder arthroplasty
A history of shoulder septic arthritis
A full thickness subscapularis tear
An acute or malunited proximal humeral fracture
Chronic locked dislocation
Rheumatoid arthritis
Tumors
Axillary nerve damage
Non-functioning deltoid muscle
Glenoid vault deficiency precluding baseplate fixation
Infection and neuropathic joints
Known or suspected non-compliance, drug or alcohol abuse
Patients incapable of judgement or under tutelage
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
The subject is related to investigator as family members, employees, or other dependent persons
Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly A Ganz
Phone
1 (800) 933-7001
Ext
71119
Email
kelly.ganz@arthrex.com
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Martino
Phone
1 (800) 933-7001
Ext
71970
Email
samantha.martino@arthrex.com
Facility Information:
Facility Name
The University of Arizona/Banner Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saleh Ahmed
Facility Name
Southern Oregon Orthopedics
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Denard, MD
Facility Name
The Hawkins Foundation
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Pergiovanni
Phone
888-666-2904
First Name & Middle Initial & Last Name & Degree
Michael Kissenberth, MD
Facility Name
The Campbell Clinic
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Knack
Facility Name
Jordan Young Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Firoved
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Subscapularis Repair in Reverse Shoulder Arthroplasty
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