The Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty

NCT03711175 | Enrolling By Invitation FDA Device

• 1 other identifier: PS-903
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

The study is a prospective, multi-center, randomized blinded study to determine how repairing the subscapularis vs. not repairing the subscapularis when subjects are implanted with the AltiVate Reverse® Shoulder System for reverse total shoulder arthroplasty affects isometric and isokinetic internal rotational strength. It is hypothesized that patients in which the subscapularis is repaired will have improved postoperative isometric and isokinetic internal rotational strength.

Conditions

Severe Arthropathy With a Grossly Deficient Rotator Cuff

Keywords

Sub-scapularis repair

Outcome Measures

Primary Outcomes (4)

• Change in isometric and isokinetic internal rotational strength of abductors

  Maximal isometric strength of shoulder abductors and measured in kilograms using a force gauge

  6 months, and 1, 2, 5 and 10 years

• Change in isometric and isokinetic internal rotational strength of flexors

  Maximal isometric strength of shoulder flexors measured in kilograms using a force gauge

  6 months, and 1, 2, 5 and 10 years

• Change in isometric and isokinetic internal rotational strength of internal rotators

  Maximal isometric strength of shoulder measured internal rotators in kilograms using a force gauge

  6 months, and 1, 2, 5 and 10 years

• Change in isometric and isokinetic internal rotational strength of external rotators

  Maximal isometric strength of shoulder measured external rotators in kilograms using a force gauge

  6 months, and 1, 2, 5 and 10 years

Secondary Outcomes (10)

• To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder

  6 months, and 1, 2, 5 and 10 years

• To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder

  6 months, and 1, 2, 5 and 10 years

• To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder

  6 months, and 1, 2, 5 and 10 years

• To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder

  6 months, and 1, 2, 5 and 10 years

• To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder

  6 weeks,6 months, and 1, 2, 5 and 10 years

Study Arms (2)

Group A

OTHER

The subscapularis is repaired. Receives device

Procedure: Subscapularis repair; Device: Shoulder implant

Group B

OTHER

The subscapularis is not repaired. Receives device

Device: Shoulder implant

Interventions

Subscapularis repair PROCEDURE

Utilizing fiberwire, high tensile strength suture

Group A

Shoulder implant DEVICE

Reverse shoulder arthroplasty device

Group A; Group B

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥21 years of age
• Subject is scheduled for reverse shoulder arthroplasty with the AltiVate Reverse device due to primary diagnosis of severe arthropathy with a grossly deficient rotator cuff
• Subject's sub scapularis has been determined from MRI to be sufficient to repair
• Subject is willing and able to comply with the study schedule and assessments
• Subject is likely to be available for evaluation for the duration of the study
• Subject is willing and able to sign the informed consent

You may not qualify if:

• Subject is indicated for reverse shoulder arthroplasty for other indications (revision arthroplasty, proximal humerus fracture, etc.), addition of latissimus transfer or pectoralis major transfer
• Subject has metal allergies or sensitivity
• Subject has an active infection at or near the site of implantation
• Subject has a nonfunctional deltoid muscle
• Subject has neuromuscular compromise condition of the shoulder
• Subject has known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
• Subject is currently on or planning to be on chemotherapy or radiation
• Subject has had chemotherapy or radiation within the last 6 months
• Subject is currently taking \> 5mg/day corticosteroids (e.g. prednisone), excluding inhalers, within 3 months prior to surgery
• Female subjects who are pregnant or planning to become pregnant within the study period
• In the investigator's opinion, the subject is unable to understand the study or be compliant with the follow up or has a history of non-compliance with medical advice
• Subject has a history of any cognitive or mental health status that would interfere with study participation
• Subject is abusing alcohol or drugs or is undergoing active treatment for substance abuse (e.g., recreational drugs, narcotics, or alcohol).

Sponsors & Collaborators

• Encore Medical, L.P.: lead

Study Sites (4)

St. Luke's Hospital

St Louis, Missouri, 63128, United States

Location

NYU Langone Center for Musculoskeletal Care

New York, New York, 10016, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Orthopedic Group

Houston, Texas, 77030, United States

Location

Study Officials

• Jessica Knowlton, MS, CRA

  DJO Global

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subject will not know which group they were randomized to until the completion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two treatment arms. One group will have the subscapularis repaired during surgery, and one group will not have the subscapularis repaired during surgery. All subjects will receive the same device.

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 18, 2018
• Study Start: September 28, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)