Mako-MORE Registry
14. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
950
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Yonandy Barrientos
- Telefonnummer: 347-281-3196
- E-Mail: yonandy.barrientos@stryker.com
Studieren Sie die Kontaktsicherung
- Name: Marissa M Puccio
- Telefonnummer: 201-675-1416
- E-Mail: marissa.puccio@stryker.com
Studienorte
-
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32224
- Noch keine Rekrutierung
- Mayo Clinic (Jacksonville)
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Kontakt:
- Bre Jenkins, MPH
- E-Mail: Jenkins.Breana@mayo.edu
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Hauptermittler:
- Bryan D. Springer, MD
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Kontakt:
- Lauren Evans, DPT
- Telefonnummer: 904-953-5416
- E-Mail: Evans.Lauren2@mayo.edu
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Kentucky
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Louisville, Kentucky, Vereinigte Staaten, 40202
- Rekrutierung
- UofL Health
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Hauptermittler:
- Arthur Malkani, MD
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Kontakt:
- Langan Smith
- Telefonnummer: 65585 502-587-8222
- E-Mail: langan.smith@uoflhealth.org
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New York
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New York, New York, Vereinigte Staaten, 10003
- Rekrutierung
- NYU Langone Orthopedic Hospital
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Hauptermittler:
- Joshua Rozell, MD
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Unterermittler:
- Matthew Hepinstall, MD
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Kontakt:
- Stephanie Frezzo, MHA
- Telefonnummer: 9172277486
- E-Mail: stephanie.Frezzo@nyulangone.org
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Kontakt:
- Daniel Warren, MSPH
- Telefonnummer: 954-559-2251
- E-Mail: daniel.warren@nyulangone.org
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44195
- Noch keine Rekrutierung
- Cleveland Clinic
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Kontakt:
- Laura Stiegel
- E-Mail: stiegel@ccf.org
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Hauptermittler:
- Nicolas S Piuzzi, MD
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Kontakt:
- Sanalkumar Krishnan, Ph.D.
- Telefonnummer: 216-445-7194
- E-Mail: KRISHNS11@ccf.org
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Rhode Island
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Wakefield, Rhode Island, Vereinigte Staaten, 02879
- Noch keine Rekrutierung
- Robotic Joint Replacement Institute - Ortho Rhode Island
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Hauptermittler:
- Robert Marchand, MD
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Kontakt:
- Kelly Taylor, BSN, RN
- Telefonnummer: 2260 401-777-7000
- E-Mail: ktaylor@orthopedicsri.com
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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).
|
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.
Andere Namen:
|
|
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).
|
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.
Andere Namen:
|
|
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).
|
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.
Andere Namen:
|
|
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).
|
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.
Andere Namen:
|
|
Manual THA (Primary)
This cohort includes patients undergoing primary total hip arthroplasty performed using manual surgical instrumentation, without robotic assistance.
|
|
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Manual TKA (Primary)
This cohort includes patients undergoing primary total knee arthroplasty performed using manual surgical instrumentation, without robotic assistance.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Implant Survivorship at 2 Years Postoperative
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Implant Survivorship at 5 Years Postoperative
Zeitfenster: 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
Zeitfenster: 5-years postoperative
|
To evaluate changes between preoperative and postoperative patient reported outcomes (PROs).
|
5-years postoperative
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
13. Juli 2026
Primärer Abschluss (Geschätzt)
15. Mai 2033
Studienabschluss (Geschätzt)
15. März 2037
Studienanmeldedaten
Zuerst eingereicht
9. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Juni 2026
Zuerst gepostet (Tatsächlich)
15. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. August 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 113 (Shenzhen Universisty general hospital)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
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