Mako-MORE Registry

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Implant Survivorship at 2 Years Postoperative [Срок оценки: 2-years postoperative]

Вторичные конечные точки (2)

• Implant Survivorship at 5 Years Postoperative [Срок оценки: 5-years postoperative]
• Change in Patient-Reported Outcomes From Baseline [Срок оценки: 5-years postoperative]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 5 центров

• Mayo Clinic (Jacksonville) — Jacksonville
• UofL Health — Louisville
• NYU Langone Orthopedic Hospital — New York
• Cleveland Clinic — Cleveland
• Ortho Rhode Island — Wakefield

Идентификаторы

NCT: NCT07647354 · 113

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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