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.
Study Type
OBSERVATIONAL
Enrollment
950
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.
Mayo Clinic (Jacksonville)
Jacksonville, Florida, United States
NOT_YET_RECRUITINGUofL Health
Louisville, Kentucky, United States
RECRUITINGNYU Langone Orthopedic Hospital
New York, New York, United States
Implant Survivorship at 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.
Time frame: 2-years postoperative
Implant Survivorship at 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.
Time frame: 5-years postoperative
Change in Patient-Reported Outcomes From Baseline
To evaluate changes between preoperative and postoperative patient reported outcomes (PROs).
Time frame: 5-years postoperative
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Cleveland Clinic
Cleveland, Ohio, United States
NOT_YET_RECRUITINGRobotic Joint Replacement Institute - Ortho Rhode Island
Wakefield, Rhode Island, United States
NOT_YET_RECRUITING