Anatomical Shoulder™ Inverse/Reverse Study

NCT02466321 | Completed Results

• 1 other identifier: 06-U02
• Study Type: interventional
• Target: 154
• Locations: 4 countries
• Sites: 5

Brief Summary

The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™ Inverse/Reverse System by analysis of standard scoring systems and radiographs. Outcome data will be collected using the following standard scoring systems of which summary statistics will be provided: • Constant and Murley Score to evaluate clinical parameters such as range of motion, power, level of pain and functional ability.

Conditions

Cuff-tear Arthropathy

Keywords

Inverse Reverse Shoulder

Outcome Measures

Primary Outcomes (1)

• Functional Performance

  Constant \& Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.

  10 years

Secondary Outcomes (1)

• Survival (Kaplan-Meier)

  10 years

Study Arms (1)

Inverse / Reverse Shoulder

EXPERIMENTAL

Patient treated with a inverse / reverse shoulder device.

Procedure: Inverse/Reverse Shoulder Arthroplasty

Interventions

Inverse/Reverse Shoulder Arthroplasty PROCEDURE

Implantation of the Anatomical Shoulder Inverse/Reverse System

Inverse / Reverse Shoulder

Eligibility Criteria

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

You may qualify if:

• Age - 18 years minimum.
• Sex - male and female.
• General Health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
• Informed Consent - patient or patient's legal representative has signed a Patient Informed Consent form.
• Indications - Diagnosis of disease or trauma in the affected joint, including cuff-tear arthropathy, failure of prior rotator cuff surgery and irreparable rotator cuff tears associated with loss of glenohumeral stability with the indication for total shoulder arthroplasty.
• The deltoid muscle has to be intact in all 3 parts (clavicular, acromial as well as spinal).

You may not qualify if:

• Patient is skeletally immature.
• Patient is pregnant.
• Patient is unwilling or unable to cooperate in a follow-up program.
• Patient shows one of the following medical conditions - Chronic fracture, Acute fracture, Axillary nerve lesion, Severe loss of humeral or glenoid bone, Paralysis of the deltoid muscle, Active Infection
• Patient requires one of the following medical interventions - Implant Revision, Glenoid bone grafting, Autografts

Sponsors & Collaborators

• Zimmer, GmbH: lead

Study Sites (5)

AZ Monica Antwerpen

Antwerp, Belgium

Location

HELIOS ENDO-Klinik Hamburg

Hamburg, Germany

Location

Vitos Orthopädische Klinik Kassel

Kassel, Germany

Location

Uniklinik Balgrist

Zurich, Switzerland

Location

The Pennine Acute Hospital NHS Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Results Point of Contact

• Title: Elliott Goff
• Organization: Zimmer Biomet

elliott.goff@zimmerbiomet.com

+41 79 222 23 08

Study Officials

• Elliott Goff, PhD

  Zimmer Biomet, Jr. Clinical Project Lead

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 9, 2015
• Study Start: May 16, 2007
• Primary Completion: February 16, 2022
• Study Completion: March 11, 2024
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-02

Locations

GB (1); DE (2); CH (1); BE (1)