ACTIVE_NOT_RECRUITING

Comprehensive SRS Regenerex Tissue Attachment

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Conditions

Arthroplasty ComplicationsOsteo Arthritis ShouldersMedical DeviceSafetyPerformance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-22
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06615739

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must be 18 years of age or older.
  2. * Patient must be willing and able to follow directions.
  3. * The Comprehensive Segmental Revision System was used in cases of:
  4. 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
  5. 2. Revision where other devices or treatments have failed.
  6. 3. Correction of functional deformity.
  7. 4. Oncology applications including bone loss due to tumor resection.
  8. * Proximal or total humeral replacement, for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
  9. * Distal or total humeral replacement for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
  10. * 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.
  11. * The Comprehensive Segmental Revision System was used with bone cement in distal humeral and total humeral applications.
  12. * Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision System
  1. * Absolute contraindications:
  2. * Infection
  3. * Sepsis
  4. * Osteomyelitis
  5. * Patient is a prisoner
  6. * Patient is a current alcohol or drug abuser
  7. * Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
  8. * Patient is unwilling to consent
  9. * Relative contraindications:
  10. * Uncooperative patient or patient with neurologic disorders who is incapable of following directions
  11. * Osteoporosis
  12. * Metabolic disorders which may impair bone formation
  13. * Osteomalacia
  14. * Distant foci of infections which may spread to the implant site
  15. * Vascular insufficiency, muscular atrophy, or neuromuscular disease
  16. * The Comprehensive Segmental Revision System was used in a reverse shoulder application in patients receiving radiation therapy
  17. * The Comprehensive Segmental Revision System was used without bone cement in distal humeral and total humeral applications.
  18. * Regenerex Tissue Attachment Augments weren't used during the patient's surgery

Contacts and Locations

Principal Investigator

Erin Osborn
STUDY_DIRECTOR
Zimmer Biomet

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Zimmer Biomet

  • Erin Osborn, STUDY_DIRECTOR, Zimmer Biomet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-22
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-10-22
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Medical Device
  • Safety
  • Performance

Additional Relevant MeSH Terms

  • Arthroplasty Complications
  • Osteo Arthritis Shoulders