Clinical trial NCT02466321: Anatomical Shoulder™ Inverse/Reverse Study
Official title: Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cuff-tear Arthropathy
Keywords: Inverse Reverse Shoulder
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-06-09
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Functional Performance
timeFrame: 10 years
Secondary outcomes:
measure: Survival (Kaplan-Meier)
timeFrame: 10 years
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: AZ Monica Antwerpen
city: Hamburg
country: Germany
facility: HELIOS ENDO-Klinik Hamburg
city: Kassel
country: Germany
facility: Vitos Orthopädische Klinik Kassel
city: Zürich
country: Switzerland
facility: Uniklinik Balgrist
city: Manchester
country: United Kingdom
facility: The Pennine Acute Hospital NHS Trust
Study officials:
affiliation: Zimmer Biomet, Jr. Clinical Project Lead
name: Elliott Goff, PhD
role: STUDY_CHAIR
References: