Ireland
--:--IST
Recruiting Observational

Mako-MORE Registry

NCT07647354 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2026-07-13
Last updated
2026-08-18

Condition(s) studied

Arthropathy of KneeArthropathy of Hip

Investigational drug(s) / intervention(s)

Mako Robotic-Arm Assisted Arthroplasty

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Implant Survivorship at 2 Years Postoperative — 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.

Trial sites (5)

FacilityCityRegionStatus
Mayo Clinic (Jacksonville) Jacksonville Florida Not Yet Recruiting
UofL Health Louisville Kentucky Recruiting
NYU Langone Orthopedic Hospital New York New York Recruiting
Cleveland Clinic Cleveland Ohio Not Yet Recruiting
Robotic Joint Replacement Institute - Ortho Rhode Island Wakefield Rhode Island Not Yet Recruiting

More Stryker Orthopaedics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07647354 on ClinicalTrials.gov ↗ ← All trials in the USA