Mirror Medacta Shoulder System Pivotal Trial

Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.

The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.

Study Overview

• Status: Recruiting
• Conditions: Arthritis Shoulder; Post-traumatic Arthrosis of Other Joints, Upper Arm
• Intervention / Treatment: Device: Mirror Medacta Shoulder System; Device: Medacta Shoulder System

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Viganò, PhD; Phone Number: +41 091 6966060; Email: m.vigano@medacta.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3006
    • Recruiting
    • Lindenhofgruppe AG - Orthopädie Sonnenhof
    • Contact: Annabel Hayoz; Email: annabel.hayoz@lindenhofgruppe.ch
    • Principal Investigator: Matthias A Zumstein, Prof Dr med
  • Saint Gallen, Switzerland, 9007
    • Recruiting
    • Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen
    • Contact: Vilijam Zdravkovic, MD; Email: Vilijam.Zdravkovic@kssg.ch
    • Principal Investigator: Bernhard Jost, Prof Dr. med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 yr
• Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis
• Willingness and ability to comply with study protocol

Exclusion Criteria:

• Medical condition or balance impairment that could lead to falls
• Prior rotator cuff surgery
• Cuff tear arthropathy/insufficient rotator cuff
• Insufficient bone quality which may affect the stability of the implant
• Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes
• Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation
• Active metastatic or neoplastic disease at the shoulder joint
• Chemotherapy treatment/radiotherapy within 6 mo before surgery
• >5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery
• Pregnancy or plan to become pregnant during study period
• Inability to understand study or a history of noncompliance with medical advice
• Alcohol or drug abuse
• Current enrollment in any clinical research study that might interfere with this study
• Metal allergies or sensitivity.
• Previous or current infection at or near the site of implantation.
• Current distant or systemic infection
• Patient, whose infomed consent form should be taken in an emergency situation
• ONLY for women of childbearing age: a positive pregnancy test (urine / blood)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirror group; Mirror Medacta Shoulder System	Device: Mirror Medacta Shoulder System; Anatomic total shoulder arthroplasty system
Active Comparator: Historical Control group; Total shoulder arthroplasty system	Device: Medacta Shoulder System; Anatomic total shoulder arthroplasty system - standard configuration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Shoulder Score	0 (worst) - 48 (best)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success Rate	Kaplan Meier survival curve, examining the following end-points: component revision for any reason;; aseptic loosening;; any definite change in the position of components.	24 months
Oxford Shoulder Score	0 (worst) - 48 (best)	24 months
Constant score	0(worst) - 100 (best)	24 months
Subjective Shoulder Value	0(worst) - 100 (best)	24 months
Device parameters	Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty: Radiolucencies,; Migration,; Osteolysis,; Subsidence	24 months

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Matthias A Zumstein, Prof Dr. med, Lindenhofgruppe AG (Bern)

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: P06.003.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No