Clinical trial NCT06615739: Comprehensive SRS Regenerex Tissue Attachment
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthroplasty Complications
Osteo Arthritis Shoulders
Keywords: Medical Device
Safety
Performance
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Kaplan Meier Implant Survivorship
timeFrame: Up to 10 Years
measure: Safety Assessement
timeFrame: Up to 10 Years
Secondary outcomes:
measure: Assessment of performance and clinical benefits by recording patient reported QuickDASH
timeFrame: Up to 10 Years
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Toman Orthopedics and Sports Med
state: Florida
Study officials:
affiliation: Zimmer Biomet
name: Erin Osborn
role: STUDY_DIRECTOR
References: