Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05062252

Mirror Medacta Shoulder System Pivotal Trial

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lindenhofgruppe AG - Orthopädie Sonnenhof, Bern, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mirror Medacta Shoulder System

Device

Anatomic total shoulder arthroplasty system

Medacta Shoulder System

Device

Anatomic total shoulder arthroplasty system - standard configuration

Primary outcomes

  1. Oxford Shoulder Score

    Time frame: 12 months

    0 (worst) - 48 (best)

Secondary outcomes

  1. Device Success Rate

    Time frame: 24 months

    Kaplan Meier survival curve, examining the following end-points:

    • component revision for any reason;
    • aseptic loosening;
    • any definite change in the position of components.
  2. Oxford Shoulder Score

    Time frame: 24 months

    0 (worst) - 48 (best)

  3. Constant score

    Time frame: 24 months

    0(worst) - 100 (best)

  4. Subjective Shoulder Value

    Time frame: 24 months

    0(worst) - 100 (best)

  5. Device parameters

    Time frame: 24 months

    Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty:

    • Radiolucencies,
    • Migration,
    • Osteolysis,
    • Subsidence

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Viganò, PhD

CONTACT

[email protected]

+41 091 6966060

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 30, 2021
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.