Overview

This trial is active, not recruiting.

Condition cuff-tear arthropathy
Treatment inverse/reverse shoulder arthroplasty
Phase phase 4
Sponsor Zimmer, GmbH
Start date September 2005
End date September 2023
Trial size 160 participants
Trial identifier NCT02466321, 06-U02

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.

- SF-12 Physical and Mental Health Summary Measures (SF12 Questionnaire) comprising of twelve questions to assess the subject's physical and mental health status which must be answered by the patient.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patient treated with a inverse / reverse shoulder device.
inverse/reverse shoulder arthroplasty
Implantation of the Anatomical Shoulder Inverse/Reverse System

Primary Outcomes

Measure
Functional Performance
time frame: 10 years

Secondary Outcomes

Measure
Survival
time frame: 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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). Exclusion Criteria: - 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

Additional Information

Official title Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study
Description This is a multi-centre, non-comparative, prospective post-market surveillance study involving orthopaedic surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder™ Inverse/Reverse implant. All system components are CE-marked and commercially available. Patients will be selected according to the subject selection criteria. All patients will undergo pre-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at either 6 weeks or 6 months (according to the hospital's standard care plan) and thereafter at 1, 2, 5 and 10 years post hospital discharge. There are 5 study centres taking part in this project enrolling in total a maximum of 160 patients.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Zimmer, Inc..