Subscapularis Repair in Reverse Shoulder Arthroplasty

NCT05438914 | Unknown FDA Device

• 1 other identifier: AIRR-00608-20
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 6

Brief Summary

This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).

Conditions

Rotator Cuff Tear Arthropathy

Outcome Measures

Primary Outcomes (5)

• 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.

  Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure.

• 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.

  Collected at at 9 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.

• 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.

  Collected at at the 26 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.

• 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.

  Collected at at 1 year post-op timepoint, but the primary outcome is the score at 2 years post-procedure.

• 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.

  Collected at the 2 year post-op timepoint, and is the primary outcome measure

Secondary Outcomes (10)

• Ultrasound

  Collected once at either the 6 month, 1 year or 2 year timepoint.

• American Shoulder and Elbow Surgeons (ASES) subjective survey

  Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.

• Simple Shoulder Test (SST) questionnaire

  Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.

• Visual Analog Scale (VAS)

  Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.

• Western Ontario Osteoarthritis of the Shoulder Index (WOOS)

  Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.

Study Arms (2)

Reverse Shoulder Arthroplasty with subscapularis repair

EXPERIMENTAL

The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.

Device: Repair of the subscapularis

Reverse Shoulder Arthroplasty without subscapularis repair

NO INTERVENTION

The subscapularis will not be repaired.

Interventions

Repair of the subscapularis DEVICE

The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.

Reverse Shoulder Arthroplasty with subscapularis repair

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arthrex, Inc.: lead

Study Sites (6)

The University of Arizona/Banner Health

Phoenix, Arizona, 85006, United States

RECRUITING

Western Orthopaedics, P.C.

Denver, Colorado, 80218, United States

NOT YET RECRUITING

Southern Oregon Orthopedics

Medford, Oregon, 97504, United States

RECRUITING

The Hawkins Foundation

Greenville, South Carolina, 29615, United States

RECRUITING

The Campbell Clinic

Collierville, Tennessee, 38017, United States

RECRUITING

Jordan Young Institute

Norfolk, Virginia, 23462, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Central Study Contacts

Kelly A Ganz

CONTACT

1 (800) 933-7001; kelly.ganz@arthrex.com

Samantha Martino

CONTACT

1 (800) 933-7001; samantha.martino@arthrex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The patients will be randomly allocated in a 1:1 ratio, with block sizes of four and six using a randomization sequence.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 30, 2022
• Study Start: November 14, 2022
• Primary Completion: September 14, 2025
• Study Completion: September 14, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)