Zimmer Biomet
The objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb salvage arthroplasty.
Arthroplasty Complications
Osteo Arthritis Shoulders
Regenerex Tissue Attachment Augments
Consecutive subjects implanted with Comprehensive SRS Regenerex Tissue Attachment Augments according to the approved indications, with the longest-term follow-up possible, willl be identified and invited to participate in the study. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to the implant and/or procedure should be specified. The study will include one site. There will be a maximum of 103 patients enrolled in the study.
Study Type : | OBSERVATIONAL |
Estimated Enrollment : | 103 participants |
Official Title : | Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Segmental Revision System (SRS) Regenerex Tissue Attachment Augments - a Retrospective Enrollment and Prospective Follow-up Consecutive Series Study |
Actual Study Start Date : | 2024-10-01 |
Estimated Primary Completion Date : | 2026-12-31 |
Estimated Study Completion Date : | 2026-12-31 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Toman Orthopedics and Sports Med
Boca Raton, Florida, United States, 33432