Comprehensive SRS Regenerex Tissue Attachment

NCT06615739 | Active Not Recruiting FDA Device

• 1 other identifier: CMU2024-12E
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty Complications; Osteo Arthritis Shoulders

Keywords

Medical Device; Safety; Performance

Outcome Measures

Primary Outcomes (2)

• Kaplan Meier Implant Survivorship

  This will be established by recording the incidence and frequency of device revisions. Kaplan-Meier survival analysis is a statistical method that estimates survival rates over time and accounts for factors that can affect implant survival.

  Up to 10 Years

• Safety Assessement

  This will be established by recording the incidence and frequency of complications and adverse events. Relation of the events to the implant and/or procedure will be specified.

  Up to 10 Years

Secondary Outcomes (1)

• Assessment of performance and clinical benefits by recording patient reported QuickDASH

  Up to 10 Years

Study Arms (1)

Comprehensive Regenerex Tissue Attachment Augments

Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision system

Device: Regenerex Tissue Attachment Augments

Interventions

Regenerex Tissue Attachment Augments DEVICE

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

Comprehensive Regenerex Tissue Attachment Augments

Eligibility Criteria

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

Study Population

Subjects must meet the inclusion criteria to be enrolled into the study. Subjects who meet any of the exclusion criteria should not be enrolled into the study. The study population will comprise a consecutive cohort of up to 103 subjects implanted using the Comprehensive SRS Regenerex Tissue Attachment Augments.

You may qualify if:

• Patient must be 18 years of age or older.
• Patient must be willing and able to follow directions.
• The Comprehensive Segmental Revision System was used in cases of:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Oncology applications including bone loss due to tumor resection.
• Proximal or total humeral replacement, for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
• Distal or total humeral replacement for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
• Biomet Comprehensive Segmental Revision System was used in a reverse application in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff for proximal humeral replacement. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
• The Comprehensive Segmental Revision System was used with bone cement in distal humeral and total humeral applications.
• Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision System

You may not qualify if:

• Absolute contraindications:
• Infection
• Sepsis
• Osteomyelitis
• Patient is a prisoner
• Patient is a current alcohol or drug abuser
• Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
• Patient is unwilling to consent
• Relative contraindications:
• Uncooperative patient or patient with neurologic disorders who is incapable of following directions
• Osteoporosis
• Metabolic disorders which may impair bone formation
• Osteomalacia
• Distant foci of infections which may spread to the implant site
• Vascular insufficiency, muscular atrophy, or neuromuscular disease

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Toman Orthopedics and Sports Med

Boca Raton, Florida, 33432, United States

Location

Study Officials

• Erin Osborn

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 27, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (1)