Clinical Trial Finder

Comprehensive SRS Regenerex Tissue Attachment

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06615739
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Erin Osborn
Principal Investigator Affiliation Zimmer Biomet
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Arthroplasty Complications, Osteo Arthritis Shoulders
Additional Details

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.

Arms & Interventions

Arms

: Comprehensive Regenerex Tissue Attachment Augments

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

Interventions

Device: - Regenerex Tissue Attachment Augments

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Toman Orthopedics and Sports Med, Boca Raton, Florida

Status

Recruiting

Address

Toman Orthopedics and Sports Med

Boca Raton, Florida, 33432

Site Contact

Chuck V Toman, MD

[email protected]

561-221-6895

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