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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | The subscapularis is repaired. Receives device |
|
| Group B | Other | The subscapularis is not repaired. Receives device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subscapularis repair | Procedure | Utilizing fiberwire, high tensile strength suture |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Knowlton, MS, CRA | DJO Global | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Hospital | St Louis | Missouri | 63128 | United States | ||
| NYU Langone Center for Musculoskeletal Care |
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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.
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Subject will not know which group they were randomized to until the completion of the study.
| Shoulder implant |
| Device |
Reverse shoulder arthroplasty device |
|
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 |
| New York |
| New York |
| 10016 |
| United States |
| Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Texas Orthopedic Group | Houston | Texas | 77030 | United States |