Overview

This trial is active, not recruiting.

Conditions rotator cuff tear arthropathy, osteoporosis, osteomalacia, joint; destruction, sacroiliac
Treatment comprehensive
Sponsor Biomet, Inc.
Start date December 2013
End date October 2016
Trial size 100 participants
Trial identifier NCT02084693, INT.CR.GE1

Summary

Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
comprehensive
Comprehensive® Reverse Shoulder products are indicated for use 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.

Primary Outcomes

Measure
Survivorship
time frame: 1 year

Secondary Outcomes

Measure
Adverse Events (including dislocation)
time frame: 3 year
Constant-Murley Shoulder Score
time frame: 3 year
Radiographic Evaluation (Plain X-ray and CT)
time frame: 3 year
Scapular Notching
time frame: 3 year
Constant-Murley Shoulder Score
time frame: 1 year
Constant-Murley Shoulder Score
time frame: 6 Months
Radiographic Evaluation
time frame: 1 year
Radiographic Evaluation
time frame: 6 Weeks

Eligibility Criteria

Male or female participants from 60 years up to 85 years old.

Inclusion Criteria: Patients / cases to be included in this study shall utilize the following inclusion criteria: 1. Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse shoulder configuration. 2. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. 3. Grossly deficient rotator cuff with severe arthropathy and/or 1. Previously failed shoulder joint replacement with a grossly deficient rotator cuff. 2. Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or 3. Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or 4. Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Exclusion Criteria: - The exclusion criteria are the same as the indications stated in the cleared labeling for the device: Absolute contraindications include infection, sepsis, and osteomyelitis. Relative contraindications include: 1. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. 2. Osteoporosis. 3. Metabolic disorders which may impair bone formation. 4. Osteomalacia. 5. Distant foci of infections which may spread to the implant site. 6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Additional Information

Official title Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
Principal investigator Joo Han Oh, Ph.D.
Description The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes including adverse events, scapular notching, and Constant Score. All shoulders on which data will be collected are legally marketed and none of the devices are investigational or experimental. FDA has cleared this device via Premarket Notification 510(k) K080642. This data collection effort will document the clinical outcomes of the Comprehensive® Reverse shoulders. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..