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

A Prospective Multicenter Study to Examine the Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty: A Randomized, Controlled Trial.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Severe Arthropathy With a Grossly Deficient Rotator Cuff
• Intervention / Treatment: Procedure: Subscapularis repair; Device: Shoulder implant

Detailed Description

Reverse shoulder arthroplasty (RSA) is performed to provide improvement in pain relief and restoration of function in patients with rotator cuff tear arthropathy and massive irreparable rotator cuff tears . Traditional total shoulder designs failed to address the unique mechanics of shoulders with deficient rotator cuffs. Different prosthesis designs exist for RSA, all of which increase the deltoid lever arm to provide a stable fulcrum for active elevation in a rotator cuff deficient shoulder.

The Reverse® Shoulder Prosthesis (RSP®) (DJO Surgical) sought to address issues correlated to the Grammont design by lateralizing the center of rotation as well as utilizing a central compressive screw with a 5.0-mm peripheral locking screws for fixation and a glenosphere .

Despite the success of the lateralized design, the effect of the repair of the subscapularis tendon during RSA on shoulder strength, range of motion, and shoulder function remains inconclusive. The rationale for repairing the subscapularis during RSA include anatomic preservation of a functioning rotator cuff muscle, an increased potential for internal rotation, better joint protection, and more stability. The reasoning for not repairing the subscapularis include that it may be biomechanically unfavorable for both the deltoid and the posterior rotator cuff, limiting the range of motion.

As such, this randomized study aims to address if subscapularis repair impacts isometric and isokinetic internal rotational strength, with shoulder function and complications as secondary objectives, when patients are implanted with the AltiVate Reverse® device.

The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • St. Luke's Hospital
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Center for Musculoskeletal Care
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Orthopedic Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is ≥21 years of age
2. 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
3. Subject's sub scapularis has been determined from MRI to be sufficient to repair
4. Subject is willing and able to comply with the study schedule and assessments
5. Subject is likely to be available for evaluation for the duration of the study
6. Subject is willing and able to sign the informed consent

Exclusion Criteria:

1. Subject is indicated for reverse shoulder arthroplasty for other indications (revision arthroplasty, proximal humerus fracture, etc.), addition of latissimus transfer or pectoralis major transfer
2. Subject has metal allergies or sensitivity
3. Subject has an active infection at or near the site of implantation
4. Subject has a nonfunctional deltoid muscle
5. Subject has neuromuscular compromise condition of the shoulder
6. Subject has known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
7. Subject is currently on or planning to be on chemotherapy or radiation
8. Subject has had chemotherapy or radiation within the last 6 months
9. Subject is currently taking > 5mg/day corticosteroids (e.g. prednisone), excluding inhalers, within 3 months prior to surgery
10. Female subjects who are pregnant or planning to become pregnant within the study period
11. 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
12. Subject has a history of any cognitive or mental health status that would interfere with study participation
13. Subject is abusing alcohol or drugs or is undergoing active treatment for substance abuse (e.g., recreational drugs, narcotics, or alcohol).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; The subscapularis is repaired. Receives device	Procedure: Subscapularis repair; Utilizing fiberwire, high tensile strength suture; Device: Shoulder implant; Reverse shoulder arthroplasty device
Other: Group B; The subscapularis is not repaired. Receives device	Device: Shoulder implant; Reverse shoulder arthroplasty device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder	Examine operative shoulder active forward elevation	6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder	Examine operative shoulder active abduction	6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder	Examine operative shoulder active external rotation	6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder	Examine operative shoulder active internal rotation	6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder	Examine change in ASES score	6 weeks,6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder	Examine change in pain per ASES assessment	6 weeks, 6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder	Examine change in SST score	6 weeks,6 months, and 1, 2, 5 and 10 years
To evaluate change in general health with the AltiVate Reverse® Shoulder	Examine change in VR-12	6 weeks, 6 months, and 1, 2, 5 and 10 years
To evaluate change in the radiographs of AltiVate Reverse® Shoulder	Examine radiographic parameters	6 weeks, 6 months, and 1, 2, 5 and 10 years
To evaluate device survivorship of the AltiVate Reverse® Shoulder	Examine adverse events	6 weeks, 6 months, and 1, 2, 5 and 10 years

Collaborators and Investigators

• Sponsor: Encore Medical, L.P.
• Investigators: Study Director: Jessica Knowlton, MS, CRA, DJO Global

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2018
• Primary Completion (Anticipated): December 31, 2028
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Sub-scapularis repair
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: PS-903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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.: Yes