A Post-Market Clinical Evaluation of the ReUnion TSA System

NCT03858517 | Terminated Results FDA Device

• 1 other identifier: ReUnion TSA Study
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (2)

• Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative and Post-operative Adverse Events Will be Measured.

  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.

  From Baseline to last recorded follow-up (~27 Months)

Study Arms (1)

ReUnion TSA System

Subject with one or more of the following diagnoses will be treated with the ReUnion TSA System: * 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

Device: ReUnion TSA System

Interventions

ReUnion TSA System DEVICE

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.

ReUnion TSA System

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 subjects are to be enrolled in this clinical investigation. 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (3)

Great Plains Orthopedics

Peoria, Illinois, 61605, United States

Location

Tennessee Orthopaedic Alliance

Nashville, Michigan, 37209, United States

Location

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615, United States

Location

Limitations and Caveats

As the study was terminated early, outcomes and adverse events can only be reported up to the date of closure.

Results Point of Contact

• Title: Monica Fleeman
• Organization: Stryker

monica.fleeman@stryker.com

251-465-5969

Study Officials

• Rebecca Gibson

  Stryker Trauma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: February 28, 2019
• Study Start: June 25, 2019
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)