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Mako-MORE Registry

14 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

950

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224
        • Aún no reclutando
        • Mayo Clinic (Jacksonville)
        • Contacto:
        • Investigador principal:
          • Bryan D. Springer, MD
        • Contacto:
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40202
        • Reclutamiento
        • UofL Health
        • Investigador principal:
          • Arthur Malkani, MD
        • Contacto:
    • New York
      • New York, New York, Estados Unidos, 10003
        • Reclutamiento
        • NYU Langone Orthopedic Hospital
        • Investigador principal:
          • Joshua Rozell, MD
        • Sub-Investigador:
          • Matthew Hepinstall, MD
        • Contacto:
        • Contacto:
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Aún no reclutando
        • Cleveland Clinic
        • Contacto:
        • Investigador principal:
          • Nicolas S Piuzzi, MD
        • Contacto:
          • Sanalkumar Krishnan, Ph.D.
          • Número de teléfono: 216-445-7194
          • Correo electrónico: KRISHNS11@ccf.org
    • Rhode Island
      • Wakefield, Rhode Island, Estados Unidos, 02879
        • Aún no reclutando
        • Robotic Joint Replacement Institute - Ortho Rhode Island
        • Investigador principal:
          • Robert Marchand, MD
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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).
Dispositivo: 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.
Otros nombres:
  • 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).
Dispositivo: 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.
Otros nombres:
  • 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).
Dispositivo: 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.
Otros nombres:
  • 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).
Dispositivo: 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.
Otros nombres:
  • 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Implant Survivorship at 2 Years Postoperative
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Implant Survivorship at 5 Years Postoperative
Periodo de tiempo: 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
Periodo de tiempo: 5-years postoperative
To evaluate changes between preoperative and postoperative patient reported outcomes (PROs).
5-years postoperative

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Stryker Orthopaedics

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de julio de 2026

Finalización primaria (Estimado)

15 de mayo de 2033

Finalización del estudio (Estimado)

15 de marzo de 2037

Fechas de registro del estudio

Enviado por primera vez

9 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

15 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de agosto de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 113 (Shenzhen Universisty general hospital)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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