Mako-MORE Registry: Real-world Outcomes After Knee and Hip Arthroplasty

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Mako-MORE Registry is a prospective, post-market study across multiple centers that tracks patients undergoing hip or knee arthroplasty with Stryker implants, using either Mako Robotic-Arm Assisted or manual techniques. It collects demographics, surgical details, patient-reported outcomes, health utility, radiographs, and adverse events. Patients are followed from before surgery through five years after the procedure to describe real-world safety and outcomes. Neither the devices nor the procedures are experimental; all practices align with FDA-cleared labeling and standard care. The study includes both Mako-assisted and manual cohorts to compare real-world performance and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• UofL Health
  Louisville, Kentucky, United States Recruiting
• NYU Langone Orthopedic Hospital
  New York, New York, United States Recruiting
• Mayo Clinic (Jacksonville)
  Jacksonville, Florida, United States Not yet recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Not yet recruiting
• Robotic Joint Replacement Institute - Ortho Rhode Island
  Wakefield, Rhode Island, United States Not yet recruiting

Study contacts

• Study coordinator: Yonandy Barrientos
• Email: yonandy.barrientos@stryker.com
• Phone: 347-281-3196

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.