This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion TSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion TSA System will be demonstrated through reporting of device-related intra-operative and post-operative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter up to 10 years following the index procedure.
Study Type
OBSERVATIONAL
Enrollment
51
The ReUnion TSA System is designed as an anatomical total shoulder or hemi-shoulder endoprosthesis to address advanced arthritic disorders affecting the shoulder joint in subjects having intact or repairable rotator cuff function. The ReUnion TSA System consists of a completely modular shoulder platform including a Humeral Stem, Humeral Head and Glenoid. The intended purposes of the ReUnion TSA System are to achieve pain relief, improvement of range of motion and restoration or improvement of the shoulder function while ensuring long-term replacement of the shoulder joint with sufficient stability of all endoprosthesis components.
Great Plains Orthopedics
Peoria, Illinois, United States
Tennessee Orthopaedic Alliance
Nashville, Michigan, United States
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, United States
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Time frame: 24 months
Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative and Post-operative Adverse Events Will be Measured.
Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative adverse events.
Time frame: 24 mths
Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Total or Partial Prosthesis With Full or Partial Implant Survival.
Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects enrolled who have the ReUnion RFX System.
Time frame: From Baseline to last recorded follow-up (~27 Months)
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