Comprehensive Reverse Shoulder Data Collection

Osteoarthritis of the Shoulder Clinical Trial

Official title:

Comprehensive Reverse Shoulder Clinical Outcomes Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03404778
• Other study ID #: ORTHO.CR.EX007
• Status: Enrolling by invitation
• Start date: March 7, 2010
• Est. completion date: December 2034

Study information

• Verified date: December 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.

Description:

The Biomet Comprehensive Reverse Shoulder was developed to provide an additional surgical option for patients anatomically and structurally suited to receive a reverse shoulder arthroplasty. The aim of the Biomet Comprehensive Reverse Shoulder is to increase shoulder function while reducing pain.

This is a multi-center study. Having several clinical sites will allow for multiple investigators to contribute to the results of the study. 175 implants will be included into the study. All potential study subjects will be required to participate in the Informed Consent Process.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 175
• Est. completion date: December 2034
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biomet® 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.

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

• The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Exclusion Criteria:

• Absolute contraindications include infection, sepsis, and osteomyelitis.

• 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.

Related Conditions & MeSH terms

• Arthropathy of Shoulder Region
• Grossly Deficient Rotator Cuff
• Joint Diseases
• Osteoarthritis
• Osteoarthritis of the Shoulder
• Post-Traumatic Arthitis
• Rheumatoid Arthritis Without Humeral Metaphyseal Defects

Intervention

Device:
• Biomet Comprehensive Reverse Shoulder
Designed to eliminate the potential for scapular notching, this reverse shoulder system combines a a true locking mechanism that minimized wear and oxidative breakdown with a modular central screw for secure fixation.

Locations

Country	Name	City	State
United States	Allina Health System DBA Sports and Orthopaedic Specialists	Edina	Minnesota
United States	Joint Implant Surgeons	New Albany	Ohio
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Acromion LLC	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	Pain Score is assessed for each subject by asking them to indicate their current level of pain based on a 5 level scale, with "None" as the best outcome and "Severe" as the worst. Improvement of pain score at one year from pre-operative levels will be assessed.	1 year
Secondary	Constant Shoulder Score	The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.	Pre-operative, 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years
Secondary	Presence of Scapular Notching	All radiographic images collected during the study are assessed by the Principal Investigator for the presence of scapular notching. The severity of notching will be assessed using the Nerot system, where Grade 0 indicates no notch and Grade 4 indicates the largest-sized defect in the scapula.	3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years