Back to resultsAnatomical Shoulder™ Inverse/Reverse Study
Primary Purpose
Cuff-tear Arthropathy
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Inverse/Reverse Shoulder Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Cuff-tear Arthropathy focused on measuring Inverse Reverse Shoulder
Eligibility Criteria
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
Sites / Locations
- AZ Monica Antwerpen
- HELIOS ENDO-Klinik Hamburg
- Vitos Orthopädische Klinik Kassel
- Uniklinik Balgrist
- The Pennine Acute Hospital NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inverse / Reverse Shoulder
Arm Description
Patient treated with a inverse / reverse shoulder device.
Outcomes
Primary Outcome Measures
Functional Performance
Constant & Murley Score
Secondary Outcome Measures
Survival
Kaplan-Meier
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02466321
Brief Title
Anatomical Shoulder™ Inverse/Reverse Study
Official Title
Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer, GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cuff-tear Arthropathy
Keywords
Inverse Reverse Shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inverse / Reverse Shoulder
Arm Type
Experimental
Arm Description
Patient treated with a inverse / reverse shoulder device.
Intervention Type
Procedure
Intervention Name(s)
Inverse/Reverse Shoulder Arthroplasty
Intervention Description
Implantation of the Anatomical Shoulder Inverse/Reverse System
Primary Outcome Measure Information:
Title
Functional Performance
Description
Constant & Murley Score
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Survival
Description
Kaplan-Meier
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliott Goff, PhD
Organizational Affiliation
Zimmer Biomet, Jr. Clinical Project Lead
Official's Role
Study Chair
Facility Information:
Facility Name
AZ Monica Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
HELIOS ENDO-Klinik Hamburg
City
Hamburg
Country
Germany
Facility Name
Vitos Orthopädische Klinik Kassel
City
Kassel
Country
Germany
Facility Name
Uniklinik Balgrist
City
Zürich
Country
Switzerland
Facility Name
The Pennine Acute Hospital NHS Trust
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
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Anatomical Shoulder™ Inverse/Reverse Study
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