Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel

Study Overview
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Brief Summary
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Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.

Official Title
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Randomized Clinical Trial Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel

Conditions
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Shoulder Pain, Arthropathy Shoulder, Shoulder Osteoarthritis, Shoulder Arthritis, Shoulder Arthropathy Associated With Other Conditions, Necrosis of Bone, Arthritis, Inflammatory Arthritis

Intervention / Treatment
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* Procedure: ReUnion TSA, pegged design
* Procedure: ReUnion TSA, keeled design


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects willing to sign the informed consent Male and female subjects ages 18 - 90 at the time of surgery Subjects indicated for an anatomic total shoulder arthroplasty (including primary glenohumeral osteoarthritis, avascular necrosis, and inflammatory arthritis) Exclusion Criteria: Inability to comply with follow-up requirements Known or presumed substantial rotator cuff disorders Subjects with an active or suspected latent infection in or about the shoulder Subjects with instability (surgically or non-surgically addressed) Subjects presenting with posttraumatic avascular necrosis Need for glenoid bone grafting Pregnant subjects

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pegged through SP<br>Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through a Subscapularis Peel (SP) manipulation. | Procedure: ReUnion TSA, pegged design<br>* ReUnion total shoulder arthroplasty system, pegged design<br>|
| Active Comparator: Pegged through ST<br>Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through subscapularis tenotomy (ST) manipulation. | Procedure: ReUnion TSA, pegged design<br>* ReUnion total shoulder arthroplasty system, pegged design<br>|
| Active Comparator: Keeled through SP<br>Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through a Subscapularis Peel (SP) manipulation. | Procedure: ReUnion TSA, keeled design<br>* ReUnion total shoulder arthroplasty system, keeled design<br>|
| Active Comparator: Keeled through ST<br>Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through subscapularis tenotomy (ST) manipulation. | Procedure: ReUnion TSA, keeled design<br>* ReUnion total shoulder arthroplasty system, keeled design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function of Subscapularis muscle as measured by belly-press test |  | 5 years | 
| Radiographic loosening | glenoid at risk proportion | 5 years |