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A Trial to Assess the Safety and Effectiveness of an Anatomic Total Shoulder System

14. september 2026 oppdatert av: Medacta USA

Randomized, Controlled, Multi-center, Prospective Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.

This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis meets the performance of currently marketed device in terms of a composite success endpoint (functional score, radiologic appearance, revisions, adverse events) at 24 months of follow up.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

286

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Arizona
      • Gilbert, Arizona, Forente stater, 85297
        • OrthoArizona
        • Ta kontakt med:
        • Hovedetterforsker:
          • Austin Smith, MD
    • Florida
      • Boca Raton, Florida, Forente stater, 33428
      • Gulf Breeze, Florida, Forente stater, 32561
      • Tampa, Florida, Forente stater, 33607
    • Indiana
      • Fishers, Indiana, Forente stater, 46037
        • Central Indiana Orthopedics
        • Hovedetterforsker:
          • Brian Badman, MD
    • Maryland
      • Columbia, Maryland, Forente stater, 21044
        • Johns Hopkins - Washington
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Umasuthan Srikumaran, MD
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
    • New York
      • New York, New York, Forente stater, 10021
        • Cornell Med NY
        • Ta kontakt med:
        • Hovedetterforsker:
          • Theodore Blaine, MD
    • Oregon
    • Pennsylvania
    • Utah
      • Salt Lake City, Utah, Forente stater, 84108
      • St. George, Utah, Forente stater, 84790
        • Intermountain Health
        • Ta kontakt med:
        • Hovedetterforsker:
          • Zachary Leitze, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adult subject 22 years or older
  • Clinical indication for total shoulder replacement due to osteoarthritis, and/or post-traumatic arthritis.
  • Scapula and proximal humerus must have reached skeletal maturity
  • Willing and able to comply with the protocol
  • Willing and able to sign the informed consent (or the Legally Authorized Representative will sign for the subject)

Exclusion Criteria:

  • Lack of sufficient bone quality that in the Investigator's medical judgment could compromise implant fixation or bone healing, including conditions such as:
  • Rapid joint destruction, marked bone loss or bone resorption;
  • Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and
  • Osteomalacia
  • osteoporosis
  • rheumatoid arthritis
  • Metal allergies or sensitivity, including a known allergic reaction to implant metals (e.g., nickel) or polyethylene
  • Patient presents with a malunion or non-union of the tuberosities of the proximal humerus.
  • Infection at or near the site of implantation, including:
  • Glenohumeral joint infection
  • Osteomyelitis
  • Distant or systemic infection
  • Medical conditions or balance impairments that could lead to falls
  • Prior Total, or Reverse Total Shoulder arthroplasty in the affected shoulder.
  • Prior failed rotator cuff surgery, but excluding successful shoulder arthroscopy
  • Any full thickness rotator cuff tear at the time of surgery or a nonfunctional rotator cuff
  • Excessive glenoid bone loss defined by preoperative computed tomography (CT) scans of the shoulder which show insufficient glenoid bone, or insufficient bone identified at the time of surgery
  • Metabolic disorders which may impair bone function
  • Nonfunctional deltoid muscle
  • Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint)
  • Patients diagnosed with severe shoulder instability
  • Patients diagnosed with subscapularis incompetence
  • Known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
  • Currently, or within the last 6 months, or planning to be on chemotherapy or radiation
  • Currently taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery or patients presenting with symptoms of chronic steroid use. (oral steroids for a chronic condition for 12 months prior to and including the date of surgery)
  • Female subjects who are pregnant or planning to become pregnant within the study period
  • In the surgeon's opinion, the subject is unable to understand the study or be compliant with the follow up or have a history of non-compliance with medical advice
  • History of any cognitive or mental health status that would interfere with study participation
  • Substance Use Disorder (alcohol and/or drug)
  • Engages in manual labor or sports activities that could affect shoulder outcome
  • Patients who have a work-related injury leading to shoulder OA
  • Currently enrolled in any clinical research study that might interfere with the current study endpoints
  • Patients with a life expectancy of less than three years
  • Medical condition or balance impairment that could lead to falls
  • Weight bearing shoulder due to wheelchair, crutches, rollator at the time of operation
  • Individuals who are incarcerated or detained in a correctional facility or under any form of legal supervision that limits their ability to voluntarily consent to participate in the trial.
  • Previous randomization of the subject in the current study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 143 undergoing implantation of the Mirror Anatomic Shoulder Prosthesis (investigational)
Enhet: Mirror Anatomic Total Shoulder Prosthesis
Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function. To reduce polyethylene wear, a new Shoulder System, mirroring the materials at the humeral/glenoid interface.
Aktiv komparator: 143 patients undergoing implantation of Medacta Anatomic Shoulder (control)
Enhet: Medacta Anatomic Shoulder
Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis is non-inferior to the performance of currently marketed devices in terms of a composite success endpoint
Tidsramme: 24 months of follow up
The primary endpoint is clinical success, that will be determined if the following 4 criteria are met: No device-related serious adverse event have occurred, ASES score improved more than the Minimally Clinical Important Difference and is at least "fair", No radiological signs of implant subsidence, loosening or progressive radiolucency observed in the humeral or glenoid compartment, as defined in the Radiographic Evaluation Protocol, No revisions, removals, reoperations, or supplemental fixations.
24 months of follow up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Secondary objectives include the assessment of shoulder-specific function and overall health-related quality of life over time using validated patient-reported outcome measures.
Tidsramme: 24 Months of follow up
The secondary endpoint at 24 months will be determined at the 6-week, 6-month, and 1-year timepoints. Radiographic evaluation and assessment, a 100-point patient-reported scale used to evaluate shoulder pain and daily function, 12 questions used to measure general physical/mental health from a patient's perspective (This is evaluated 0-100), Implant survival, and Adverse Events.
24 Months of follow up

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medacta USA

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. desember 2029

Datoer for studieregistrering

Først innsendt

11. august 2026

Først innsendt som oppfylte QC-kriteriene

4. september 2026

Først lagt ut (Faktiske)

10. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • MUSA-MIRROR1-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

Undetermined at this time.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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