A Post-Market Clinical Evaluation of the ReUnion TSA System

Shoulder Arthroplasty Clinical Trial

Official title:

A Post-Market Clinical Evaluation of the ReUnion TSA System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03858517
• Other study ID #: ReUnion TSA Study
• Status: Terminated
• Start date: June 25, 2019
• Est. completion date: July 8, 2022

Study information

• Verified date: July 2022
• Source: Stryker Trauma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: July 8, 2022
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Subject is willing to sign the informed consent.

• Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.

• Subject is male or non-pregnant female and 18 years or older at the time of surgery.

• Subject has one or more of the following:

• Aseptic necrosis of the humeral head

• Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis

• Failed previous total shoulder replacement, resurfacing or other procedure

Exclusion Criteria:

• Subject has an active or suspected latent infection in or about the shoulder joint.

• Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.

• Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.

• Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation.

• Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself.

• Subject has absent, irreparable or non-functioning rotator cuff and other essential muscles.

• Subject has concomitant disease(s) which may significantly affect the clinical outcome.

• Subject has traumatic or pathologic fracture of the proximal humerus.

Related Conditions & MeSH terms

• Shoulder Arthroplasty

Intervention

Device:
• ReUnion TSA System
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.

Locations

Country	Name	City	State
United States	Steadman Hawkins Clinic of the Carolinas	Greenville	South Carolina
United States	Tennessee Orthopaedic Alliance	Nashville	Michigan
United States	Great Plains Orthopedics	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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.	10 years
Secondary	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.	10 years