COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate

Completed

• Conditions: Osteoporosis; Osteomalacia; Joint; Destruction, Sacroiliac; Rotator Cuff Tear Arthropathy
• Interventions: Device: COMPREHENSIVE

• Registration Number: NCT02084693
• Lead Sponsor: Zimmer Biomet

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-12
• Status Verified: 2018-06
• Primary Completion: 2019-04
• Study Completion: 2019-06
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COMPREHENSIVE	COMPREHENSIVE	Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.

Primary Outcome Measures

Name	Time	Method
Survivorship	1 year	The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.

Secondary Outcome Measures

Name	Time	Method
Constant-Murley Shoulder Score	6 Months	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Adverse Events (including dislocation)	3 year	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Radiographic Evaluation (Plain X-ray and CT)	3 year	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Scapular Notching	3 year	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes
Radiographic Evaluation	6 Weeks	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes

Trial Locations

Locations (5)

Bunndang Seoul Nat'l Univ. Hospital; 🇰🇷 Seongnam-si, Seongnam, Korea, Republic of

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of

Gangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee Univ Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of