COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate

NCT02084693 | Completed DMC

• 1 other identifier: INT.CR.GE1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Rotator Cuff Tear Arthropathy; Osteoporosis; Osteomalacia; Joint; Destruction, Sacroiliac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Adverse Events (including dislocation)

  3 year

• Constant-Murley Shoulder Score

  3 year

• Radiographic Evaluation (Plain X-ray and CT)

  3 year

• Scapular Notching

  3 year

• Constant-Murley Shoulder Score

  1 year

Study Arms (1)

COMPREHENSIVE

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

Device: COMPREHENSIVE

Interventions

COMPREHENSIVE DEVICE

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.

COMPREHENSIVE

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse shoulder configuration.
• The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
• 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.

You may not qualify if:

• Absolute contraindications include infection, sepsis, and osteomyelitis.
• Relative contraindications include:
• Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
• Osteoporosis.
• Metabolic disorders which may impair bone formation.
• Osteomalacia.
• Distant foci of infections which may spread to the implant site.
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (5)

Bunndang Seoul Nat'l Univ. Hospital

Seongnam-si, Seongnam, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Gangnam Sacred Heart Hospital

Seoul, South Korea

Location

Kyung Hee Univ Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy; Osteoporosis; Osteomalacia

Interventions

Comprehensive Metabolic Panel

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Rickets; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 12, 2014
• Study Start: December 1, 2013
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)