COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate

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

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Osteomalacia; Rotator Cuff Tear Arthropathy; Joint; Destruction, Sacroiliac
• Intervention / Treatment: Device: COMPREHENSIVE

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Kyung Hee Univ Hospital
  • Seongnam
    • Seongnam-si, Seongnam, Korea, Republic of
      • Bunndang Seoul Nat'l Univ. Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Therefore, patients / cases to be included in this study shall utilize the following inclusion criteria:

1. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

2. Grossly deficient rotator cuff with severe arthropathy and/or

   • Previously failed shoulder joint replacement with a grossly deficient rotator cuff.
   • Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
   • Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
   • Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COMPREHENSIVE; Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Scapular Notching	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes	3 year
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
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
Radiographic Evaluation	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes	1 year
Radiographic Evaluation	Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes	6 Weeks

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Joo Han Oh, Ph.D., Bundang Seoul Nat'l University Hospital; Principal Investigator: Sang Jin Shin, Ph.D., Ewha Womans University Mokdong Hospital; Principal Investigator: Jae Chul Yoo, Ph. D., Samsung Medical Center; Principal Investigator: Yong Girl Rhee, Ph.D., Kyung Hee Univ. Hospital; Principal Investigator: Kyu Chul Noh, Ph.D., Gangnam Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Nutrition Disorders; Joint Diseases; Musculoskeletal Diseases; Arthritis; Rupture; Shoulder Injuries; Tendon Injuries; Avitaminosis; Deficiency Diseases; Malnutrition; Bone Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Crystal Arthropathies; Rickets; Vitamin D Deficiency; Chondrocalcinosis; Rotator Cuff Injuries; Osteoporosis; Osteomalacia; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: INT.CR.GE1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No