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

• ClinicalTrials.gov Identifier: NCT03711175
• Recruitment Status: Enrolling by invitation
• First Posted: October 18, 2018
• Last Update Posted: March 5, 2021
• Sponsor: Encore Medical, L.P.
• Information provided by (Responsible Party): Encore Medical, L.P.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Severe Arthropathy With a Grossly Deficient Rotator Cuff	Procedure: Subscapularis repair; Device: Shoulder implant	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Single (Participant)
• Masking Description: Subject will not know which group they were randomized to until the completion of the study.
• Primary Purpose: Treatment
• Official Title: A Prospective Multicenter Study to Examine the Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty: A Randomized, Controlled Trial.
• Actual Study Start Date: September 28, 2018
• Estimated Primary Completion Date: December 31, 2028
• Estimated Study Completion Date: December 31, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in isometric and isokinetic internal rotational strength of abductors [ Time Frame: 6 months, and 1, 2, 5 and 10 years ]
   Maximal isometric strength of shoulder abductors and measured in kilograms using a force gauge
2. Change in isometric and isokinetic internal rotational strength of flexors [ Time Frame: 6 months, and 1, 2, 5 and 10 years ]
   Maximal isometric strength of shoulder flexors measured in kilograms using a force gauge
3. Change in isometric and isokinetic internal rotational strength of internal rotators [ Time Frame: 6 months, and 1, 2, 5 and 10 years ]
   Maximal isometric strength of shoulder measured internal rotators in kilograms using a force gauge
4. Change in isometric and isokinetic internal rotational strength of external rotators [ Time Frame: 6 months, and 1, 2, 5 and 10 years ]
   Maximal isometric strength of shoulder measured external rotators in kilograms using a force gauge

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Locations

United States, Missouri

St. Luke's Hospital

Saint Louis, Missouri, United States, 63128

United States, New York

NYU Langone Center for Musculoskeletal Care

New York, New York, United States, 10016

United States, Pennsylvania

Rothman Institute

Philadelphia, Pennsylvania, United States, 19107

United States, Texas

Texas Orthopedic Group

Houston, Texas, United States, 77030

Sponsors and Collaborators

Encore Medical, L.P.

More Information

• Responsible Party: Encore Medical, L.P.
• ClinicalTrials.gov Identifier: NCT03711175
• Other Study ID Numbers: PS-903
• First Posted: October 18, 2018
• Last Update Posted: March 5, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Encore Medical, L.P.:

Sub-scapularis repair

Additional relevant MeSH terms:

Joint Diseases; Musculoskeletal Diseases