COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate

N/ACompletedNCT02084693

Zimmer Biomet100 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Rotator Cuff Tear Arthropathy Osteoporosis Osteomalacia Joint; Destruction, Sacroiliac

Interventions

COMPREHENSIVEDEVICE

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (5)

Bunndang Seoul Nat'l Univ. Hospital

Seongnam-si, Seongnam, South Korea

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Gangnam Sacred Heart Hospital

Seoul, South Korea

Kyung Hee Univ Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Survivorship

The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.

Time frame: 1 year