Anatomical Shoulder™ Inverse/Reverse Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-16

Study Completion Date

2024-03-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anatomical Shoulder Domelock System Study

NCT03312465

Avascular Necrosis Revision Surgery Conditions Consequent to Earlier Operations +3 more

ACTIVE_NOT_RECRUITING

Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty

NCT03617107

Osteo Arthritis Shoulders Proximal Humeral Fracture Rotator Cuff Tear +1 more

UNKNOWN

Comprehensive Reverse Shoulder Data Collection

NCT03404778

Arthropathy of Shoulder Region Grossly Deficient Rotator Cuff Osteoarthritis of the Shoulder +2 more

ENROLLING_BY_INVITATION

Reverse Shoulder Prosthesis Study

NCT00764504

Rotator Cuff Arthropathy Failed Total Shoulder Failed Hemi-arthroplasty

COMPLETED PHASE3

PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System

NCT05358574

Revision of a Shoulder Prosthesis

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cuff-tear Arthropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inverse / Reverse Shoulder

Patient treated with a inverse / reverse shoulder device.

Group Type EXPERIMENTAL

Inverse/Reverse Shoulder Arthroplasty

Intervention Type PROCEDURE

Implantation of the Anatomical Shoulder Inverse/Reverse System

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inverse/Reverse Shoulder Arthroplasty

Implantation of the Anatomical Shoulder Inverse/Reverse System

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No