Mirror Medacta Shoulder System Pivotal Trial

Arthritis Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062252
• Other study ID #: P06.003.01
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2023
• Source: Medacta International SA
• Contact: Marco Viganò, PhD
• Phone: +41 091 6966060
• Email: m.vigano[@]medacta.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis Shoulder
• Osteoarthritis
• Post-traumatic Arthrosis of Other Joints, Upper Arm

Intervention

Device:
• Mirror Medacta Shoulder System
Anatomic total shoulder arthroplasty system
• Medacta Shoulder System
Anatomic total shoulder arthroplasty system - standard configuration

Locations

Country	Name	City	State
Switzerland	Lindenhofgruppe AG - Orthopädie Sonnenhof	Bern
Switzerland	Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Shoulder Score	0 (worst) - 48 (best)	12 months
Secondary	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
Secondary	Oxford Shoulder Score	0 (worst) - 48 (best)	24 months
Secondary	Constant score	0(worst) - 100 (best)	24 months
Secondary	Subjective Shoulder Value	0(worst) - 100 (best)	24 months
Secondary	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