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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthroplasty Complications; Osteo Arthritis Shoulders
• Intervention / Treatment: Device: Regenerex Tissue Attachment Augments

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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33432
      • Toman Orthopedics and Sports Med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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:

  1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
  2. Revision where other devices or treatments have failed.
  3. Correction of functional deformity.
  4. 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

Exclusion Criteria:

• 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
• The Comprehensive Segmental Revision System was used in a reverse shoulder application in patients receiving radiation therapy
• The Comprehensive Segmental Revision System was used without bone cement in distal humeral and total humeral applications.
• Regenerex Tissue Attachment Augments weren't used during the patient's surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Comprehensive Regenerex Tissue Attachment Augments; Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision system	Device: Regenerex Tissue Attachment Augments; Patient will have been previously implanted with Regenerex Tissue Attachment Augments in combination with the Comprehensive Segmental Revision System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of performance and clinical benefits by recording patient reported QuickDASH	QuickDASH, or Quick Disabilities of the Arm, Shoulder, and Hand, is a questionnaire that measures the impact of upper limb musculoskeletal disorders on physical function and symptoms. The QuickDASH has 11 items that cover six domains: Daily activities: How much difficulty the patient has performing physical activities Symptoms: How severe the patient's pain and tingling is Social function: How the patient's problem affects their social activities Work function: How the patient's problem affects their work Sleep: How the patient's problem affects their sleep Confidence: How the patient's problem affects their confidence Each item is rated on a 5-point Likert scale, with 1 being no difficulty and 5 being unable. The score is then converted to a 100-point scale, with 100 representing the greatest disability.	Up to 10 Years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Erin Osborn, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Performance; Medical Device
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: CMU2024-12E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD may not be shared due to this being a single center retrospective enrollment/prospective FUP with one single reference point. Additionally, data is being collected for EU regulatory purposes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No