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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02084693
Other study ID # INT.CR.GE1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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