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Mirror Medacta Shoulder System Pivotal Trial

Sponsor
Medacta International SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05062252
Collaborator
(none)
100
Enrollment
2
Locations
2
Arms
47.8
Anticipated Duration (Months)
50
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Mirror Medacta Shoulder System
  • Device: Medacta Shoulder System
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.
Actual Study Start Date :
Jan 5, 2022
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Oxford Shoulder Score [12 months]

    0 (worst) - 48 (best)

Secondary Outcome Measures

  1. Device Success Rate [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 [24 months]

    0 (worst) - 48 (best)

  3. Constant score [24 months]

    0(worst) - 100 (best)

  4. Subjective Shoulder Value [24 months]

    0(worst) - 100 (best)

  5. Device parameters [24 months]

    Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty: Radiolucencies, Migration, Osteolysis, Subsidence

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lindenhofgruppe AG - Orthopädie Sonnenhof Bern Switzerland 3006
2 Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen Saint Gallen Switzerland 9007

Sponsors and Collaborators

  • Medacta International SA

Investigators

  • Principal Investigator: Matthias A Zumstein, Prof Dr. med, Lindenhofgruppe AG (Bern)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medacta International SA
ClinicalTrials.gov Identifier:
NCT05062252
Other Study ID Numbers:
  • P06.003.01
First Posted:
Sep 30, 2021
Last Update Posted:
Apr 13, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis

Study Results

No Results Posted as of Apr 13, 2022