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Mako-MORE Registry

14. august 2026 opdateret af: Stryker Orthopaedics

A Prospective, Multi-center, Post-market, Registry-based Evaluation of the Clinical Outcomes in Patients Receiving a Stryker Implant With Use of the Mako Robotic-Arm Assisted System (Mako-MORE)

This is a prospective, post-market, multi-center, registry-based observational study designed to collect real-world clinical data on patients undergoing joint arthroplasty with Stryker implants, with or without the use of the Mako Robotic-Arm Assisted System. The registry will collect prospective data on patient characteristics, procedural details, patient-reported outcomes, radiographic assessments, and adverse events. Patients will be enrolled into procedure-specific cohorts and followed for up to five years postoperatively.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The Mako-MORE Registry is a prospective, post-market, multi-center registry-based evaluation of the Mako Robotic-Arm Assisted System used in total hip arthroplasty (primary and revision), total knee arthroplasty, and partial knee arthroplasty. The registry includes both Mako-assisted and manual arthroplasty cohorts to support real-world data collection.

Eligible patients undergoing arthroplasty using cleared Mako SmartRobotics™ applications or manual procedures will be enrolled and followed according to standard-of-care clinical practice. Data collected include demographics, procedural details, patient-reported outcomes, health utility measures, radiographic imaging, and adverse event information. Follow-up assessments will occur from the preoperative period through five years postoperatively.

The primary purpose of the registry is observational and descriptive. No investigational devices or experimental interventions are used, and all procedures are performed in accordance with FDA-cleared labeling and institutional standards of care.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

950

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Ikke rekrutterer endnu
        • Mayo Clinic (Jacksonville)
        • Kontakt:
        • Ledende efterforsker:
          • Bryan D. Springer, MD
        • Kontakt:
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Rekruttering
        • UofL Health
        • Ledende efterforsker:
          • Arthur Malkani, MD
        • Kontakt:
    • New York
      • New York, New York, Forenede Stater, 10003
        • Rekruttering
        • NYU Langone Orthopedic Hospital
        • Ledende efterforsker:
          • Joshua Rozell, MD
        • Underforsker:
          • Matthew Hepinstall, MD
        • Kontakt:
        • Kontakt:
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Ikke rekrutterer endnu
        • Cleveland Clinic
        • Kontakt:
        • Ledende efterforsker:
          • Nicolas S Piuzzi, MD
        • Kontakt:
    • Rhode Island
      • Wakefield, Rhode Island, Forenede Stater, 02879
        • Ikke rekrutterer endnu
        • Robotic Joint Replacement Institute - Ortho Rhode Island
        • Ledende efterforsker:
          • Robert Marchand, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The subject population enrolled within the study is reflective of the anticipated real-world patients who would be appropriate candidates for treatment using Mako SmartRobotics™ applications and indications or manual surgery, depending on the relevant study cohorts

Beskrivelse

Inclusion Criteria:

  • The subject is skeletally mature, and ≥ 18 years old.
  • The Subject has signed and dated an IRB/EC approved, study specific Informed Patient Consent Form (ICF).
  • The subject is scheduled to undergo manual arthroplasty or Mako Robotic-Arm Assisted Arthroplasty according to IFU.
  • The subject is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion Criteria:

  • The subject is not able to express his/her consent as deemed by the investigator.
  • The subject is not able to fulfill a self-assessment questionnaire or follow-up visits as deemed by the investigator.
  • The subject is a prisoner.
  • Per surgeon discretion the subject is not a candidate for the study.
  • The subject is pregnant or breastfeeding.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
5.0 THA (Primary)
This cohort includes patients undergoing primary total hip arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (THA 5.0 application).
Enhed: Mako Robotic-Arm Assisted Arthroplasty
This observational registry does not assign or mandate any intervention. Participants included in this group undergo hip or knee arthroplasty using the FDA-cleared Mako Robotic-Arm Assisted System as part of routine clinical care. Surgical approach, implant selection, and perioperative management are determined by the treating surgeon according to standard practice. Outcomes are observed prospectively without alteration to clinical care.
Andre navne:
  • Mako SmartRobotics™ System
5.0 THA (Revision)
This cohort includes patients undergoing revision total hip arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (THA 5.0 application).
Enhed: Mako Robotic-Arm Assisted Arthroplasty
This observational registry does not assign or mandate any intervention. Participants included in this group undergo hip or knee arthroplasty using the FDA-cleared Mako Robotic-Arm Assisted System as part of routine clinical care. Surgical approach, implant selection, and perioperative management are determined by the treating surgeon according to standard practice. Outcomes are observed prospectively without alteration to clinical care.
Andre navne:
  • Mako SmartRobotics™ System
3.0 TKA (Primary)
This cohort includes patients undergoing primary total knee arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (TKA 3.0 application).
Enhed: Mako Robotic-Arm Assisted Arthroplasty
This observational registry does not assign or mandate any intervention. Participants included in this group undergo hip or knee arthroplasty using the FDA-cleared Mako Robotic-Arm Assisted System as part of routine clinical care. Surgical approach, implant selection, and perioperative management are determined by the treating surgeon according to standard practice. Outcomes are observed prospectively without alteration to clinical care.
Andre navne:
  • Mako SmartRobotics™ System
3.1 PKA (Primary)
This cohort includes patients undergoing primary partial knee arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (PKA 3.1 application).
Enhed: Mako Robotic-Arm Assisted Arthroplasty
This observational registry does not assign or mandate any intervention. Participants included in this group undergo hip or knee arthroplasty using the FDA-cleared Mako Robotic-Arm Assisted System as part of routine clinical care. Surgical approach, implant selection, and perioperative management are determined by the treating surgeon according to standard practice. Outcomes are observed prospectively without alteration to clinical care.
Andre navne:
  • Mako SmartRobotics™ System
Manual THA (Primary)
This cohort includes patients undergoing primary total hip arthroplasty performed using manual surgical instrumentation, without robotic assistance.
Manual TKA (Primary)
This cohort includes patients undergoing primary total knee arthroplasty performed using manual surgical instrumentation, without robotic assistance.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Implant Survivorship at 2 Years Postoperative
Tidsramme: 2-years postoperative
To evaluate survival rate at 2-years postoperative for Stryker devices implanted with the Mako Robotic-Arm Assisted System. Survival is defined as the absence of revision for implanted devices.
2-years postoperative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Implant Survivorship at 5 Years Postoperative
Tidsramme: 5-years postoperative
To evaluate survival rate at 5-years postoperative for Stryker devices implanted with the Mako Robotic-Arm Assisted System. Survival is defined as the absence of revision for implanted devices.
5-years postoperative
Change in Patient-Reported Outcomes From Baseline
Tidsramme: 5-years postoperative
To evaluate changes between preoperative and postoperative patient reported outcomes (PROs).
5-years postoperative

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stryker Orthopaedics

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. juli 2026

Primær færdiggørelse (Anslået)

15. maj 2033

Studieafslutning (Anslået)

15. marts 2037

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. august 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 113 (Shenzhen Universisty general hospital)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner