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

Primary Purpose

Severe Arthropathy With a Grossly Deficient Rotator Cuff

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Subscapularis repair
Shoulder implant
Sponsored by
Encore Medical, L.P.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Arthropathy With a Grossly Deficient Rotator Cuff focused on measuring Sub-scapularis repair

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • St. Luke's Hospital
  • NYU Langone Center for Musculoskeletal Care
  • Rothman Institute
  • Texas Orthopedic Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A

Group B

Arm Description

The subscapularis is repaired. Receives device

The subscapularis is not repaired. Receives device

Outcomes

Primary Outcome Measures

Change in isometric and isokinetic internal rotational strength of abductors
Maximal isometric strength of shoulder abductors and measured in kilograms using a force gauge
Change in isometric and isokinetic internal rotational strength of flexors
Maximal isometric strength of shoulder flexors measured in kilograms using a force gauge
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
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

Secondary Outcome Measures

To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Examine operative shoulder active forward elevation
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Examine operative shoulder active abduction
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Examine operative shoulder active external rotation
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Examine operative shoulder active internal rotation
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Examine change in ASES score
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Examine change in pain per ASES assessment
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Examine change in SST score
To evaluate change in general health with the AltiVate Reverse® Shoulder
Examine change in VR-12
To evaluate change in the radiographs of AltiVate Reverse® Shoulder
Examine radiographic parameters
To evaluate device survivorship of the AltiVate Reverse® Shoulder
Examine adverse events

Full Information

First Posted
October 11, 2018
Last Updated
March 21, 2022
Sponsor
Encore Medical, L.P.
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1. Study Identification

Unique Protocol Identification Number
NCT03711175
Brief Title
The Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty
Official Title
A Prospective Multicenter Study to Examine the Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty: A Randomized, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Encore Medical, L.P.

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.
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Arthropathy With a Grossly Deficient Rotator Cuff
Keywords
Sub-scapularis repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Subject will not know which group they were randomized to until the completion of the study.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
The subscapularis is repaired. Receives device
Arm Title
Group B
Arm Type
Other
Arm Description
The subscapularis is not repaired. Receives device
Intervention Type
Procedure
Intervention Name(s)
Subscapularis repair
Intervention Description
Utilizing fiberwire, high tensile strength suture
Intervention Type
Device
Intervention Name(s)
Shoulder implant
Intervention Description
Reverse shoulder arthroplasty device
Primary Outcome Measure Information:
Title
Change in isometric and isokinetic internal rotational strength of abductors
Description
Maximal isometric strength of shoulder abductors and measured in kilograms using a force gauge
Time Frame
6 months, and 1, 2, 5 and 10 years
Title
Change in isometric and isokinetic internal rotational strength of flexors
Description
Maximal isometric strength of shoulder flexors measured in kilograms using a force gauge
Time Frame
6 months, and 1, 2, 5 and 10 years
Title
Change in isometric and isokinetic internal rotational strength of internal rotators
Description
Maximal isometric strength of shoulder measured internal rotators in kilograms using a force gauge
Time Frame
6 months, and 1, 2, 5 and 10 years
Title
Change in isometric and isokinetic internal rotational strength of external rotators
Description
Maximal isometric strength of shoulder measured external rotators in kilograms using a force gauge
Time Frame
6 months, and 1, 2, 5 and 10 years
Secondary Outcome Measure Information:
Title
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Description
Examine operative shoulder active forward elevation
Time Frame
6 months, and 1, 2, 5 and 10 years
Title
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Description
Examine operative shoulder active abduction
Time Frame
6 months, and 1, 2, 5 and 10 years
Title
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Description
Examine operative shoulder active external rotation
Time Frame
6 months, and 1, 2, 5 and 10 years
Title
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Description
Examine operative shoulder active internal rotation
Time Frame
6 months, and 1, 2, 5 and 10 years
Title
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Description
Examine change in ASES score
Time Frame
6 weeks,6 months, and 1, 2, 5 and 10 years
Title
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Description
Examine change in pain per ASES assessment
Time Frame
6 weeks, 6 months, and 1, 2, 5 and 10 years
Title
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Description
Examine change in SST score
Time Frame
6 weeks,6 months, and 1, 2, 5 and 10 years
Title
To evaluate change in general health with the AltiVate Reverse® Shoulder
Description
Examine change in VR-12
Time Frame
6 weeks, 6 months, and 1, 2, 5 and 10 years
Title
To evaluate change in the radiographs of AltiVate Reverse® Shoulder
Description
Examine radiographic parameters
Time Frame
6 weeks, 6 months, and 1, 2, 5 and 10 years
Title
To evaluate device survivorship of the AltiVate Reverse® Shoulder
Description
Examine adverse events
Time Frame
6 weeks, 6 months, and 1, 2, 5 and 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Knowlton, MS, CRA
Organizational Affiliation
DJO Global
Official's Role
Study Director
Facility Information:
Facility Name
St. Luke's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
NYU Langone Center for Musculoskeletal Care
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Texas Orthopedic Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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