NCT06615739

Comprehensive SRS Regenerex Tissue Attachment

PMCF 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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Consecutive subjects implanted with Comprehensive SRS Regenerex Tissue Attachment Augments according to the approved indications, with the longest-term follow-up possible, will 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.

Conditions

• Arthroplasty Complications
• Osteo Arthritis Shoulders

Interventions

Type	Name	Description
DEVICE	Regenerex Tissue Attachment Augments	Patient will have been previously implanted with Regenerex Tissue Attachment Augments in combination with the Comprehensive Segmental Revision System

Timeline

• Start date: 2024-10-22
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-09-27
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study