NCT05062252

Active Not Recruiting

Mirror Medacta Shoulder System Pivotal Trial

Medacta International SA Source

Compare

Other study identifiers

Sponsor study identifier

P06.003.01

Study Type

interventional

Estimated enrollment

100

Locations

1 country

Sites

2

Timeline

Study Start

January 5, 2022

Actual (reported)

Primary Completion

December 30, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

February 28, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Estimated enrollment: 100 participants
Study completion date: February 28, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 21, 2021
Actual (reported)
First Posted
September 30, 2021
Actual (reported)
Study Start
January 5, 2022
Actual (reported)
Primary Completion
December 30, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 28, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: October 7, 2026
Status Verified: October 2026
Last Update Submitted: October 6, 2026

Conditions

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

Outcome Measures

Primary Outcomes (1)

Oxford Shoulder Score
0 (worst) - 48 (best)
12 months

Secondary Outcomes (5)

Device Success Rate
24 months
Oxford Shoulder Score
24 months
Constant score
24 months
Subjective Shoulder Value
24 months
Device parameters
24 months

Study Arms (2)

Mirror group

EXPERIMENTAL

Mirror Medacta Shoulder System

Device: Mirror Medacta Shoulder System

Historical Control group

ACTIVE COMPARATOR

Total shoulder arthroplasty system

Device: Medacta Shoulder System

Interventions

Mirror Medacta Shoulder SystemDevice

Anatomic total shoulder arthroplasty system

Mirror group

Medacta Shoulder SystemDevice

Anatomic total shoulder arthroplasty system - standard configuration

Historical Control group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 yr
Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis

Sponsors & Collaborators

Medacta International SA
Industrylead

Study Sites (2)

Lindenhofgruppe AG - Orthopädie Sonnenhof

Bern, 3006, Switzerland

Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

Study Officials

Matthias A Zumstein, Prof Dr. med
Lindenhofgruppe AG (Bern)
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 21, 2021

First Posted

September 30, 2021

Study Start

January 5, 2022

Actual (reported)

Primary Completion

December 30, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

NCT03547947

Clinical and Radiological Outcomes of Medacta Shoulder System

Active Not Recruiting

NCT05297305

Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty

Not ApplicableTerminated

NCT01390038

Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty

Phase 3Completed

NCT07815535

Three Year Outcomes After Shoulder Arthroplasty

Not Yet Recruiting

Willingness and ability to comply with study protocol

You may not qualify if:

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.
+3 more criteria

Contact the study team to confirm eligibility.

Study Completion

February 28, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

October 7, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05062252
Data provider: ClinicalTrials.gov
Source updated: 2026-10-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:46 UTC

Locations

CH(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Mirror group

Historical Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations