Mako-MORE Registry

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.

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.

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.