COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084693
• Other study ID #: INT.CR.GE1
• Status: Completed
• Start date: December 2013
• Est. completion date: June 2019

Study information

• Verified date: June 2018
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Joint; Destruction, Sacroiliac
• Osteomalacia
• Osteoporosis
• Rotator Cuff Injuries
• Rotator Cuff Tear Arthropathy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship	The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.	1 year
Secondary	Adverse Events (including dislocation)	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes	3 year
Secondary	Constant-Murley Shoulder Score	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes	3 year
Secondary	Radiographic Evaluation (Plain X-ray and CT)	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes	3 year
Secondary	Scapular Notching	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes	3 year
Secondary	Constant-Murley Shoulder Score	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes	1 year
Secondary	Constant-Murley Shoulder Score	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes	6 Months
Secondary	Radiographic Evaluation	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes	1 year
Secondary	Radiographic Evaluation	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes	6 Weeks