Safety Study of Univers® Revers Shoulder Prosthesis

NCT ID: NCT01778777

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-01
• Study Completion Date: 2023-04-15

Brief Summary

The primary safety objective is to demonstrate that severe device-related complication (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at a rate of less than 2%. Such adverse events include (but are not limited to) revisions due to dislocation or glenoid loosening, septic arthritis and scapular fractures requiring surgical repair.

Detailed Description

Reverse shoulder arthroplasty and its principles are still recognized today as the gold standard for treatment of degenerative arthropathy of the shoulder associated with an irreparable tear of the rotator cuff. The new Arthrex Univers® Revers Shoulder Prosthesis shows a large and narrow range of components, whether it is a stem, cup, spacer, inlay or glenosphere. Adjustment can be done in very small steps to match anatomic and biomechanic needs. The Arthrex Univers Revers Shoulder Prosthesis is the only device up to date that can be configured in two different inclination angles without any limitation in component use.

This multicentre case-series has the goal to evaluate whether patients with rotator cuff tear arthropathy benefit from the Univers® Revers shoulder prosthesis in terms of low complication risk, as well as high function and quality of life.

Conditions

Rotator Cuff Tear Arthropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UniverseReverse

Cohort get an universe reverse prosthesis

Group Type: EXPERIMENTAL

Universe Reverse Prosthesis

Intervention Type: DEVICE

Implantation of an universe reverse prosthesis

Interventions

Universe Reverse Prosthesis

Implantation of an universe reverse prosthesis

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient aged 18 years and over
• Patient with primary omarthrosis or secondary osteoarthritis associated with insufficiency in the centering function of the rotator cuff

and

• Willing and able to give written informed consent to participate in the study including all follow-up examinations

Exclusion Criteria

• Previous ipsilateral shoulder arthroplasty
• Acute shoulder trauma
• Post-traumatic secondary osteoarthritis
• Rheumatoid arthritis
• General medical contraindication to surgery
• Known hypersensitivity to the materials used
• Tumour / malignoma
• Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
• Bacterial infection at the time point of operation
• Recent history of substance abuse
• Legal incompetence
• Pregnancy or
• Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthrex, Inc.

INDUSTRY

Sponsor Role: collaborator

Schulthess Klinik

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans-Kaspar Schwyzer, Dr.

Role: PRINCIPAL_INVESTIGATOR

Schulthess Klinik

Locations

Schulthess Klinik

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

UniversRevers

Identifier Type: -

Identifier Source: org_study_id