Arthropathy of Hip, Arthropathy of Knee
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEMako 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.
Sponsors
Stryker Orthopaedics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survivorship at 5 Years Postoperative | 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. |
| Change in Patient-Reported Outcomes From Baseline | 5-years postoperative | To evaluate changes between preoperative and postoperative patient reported outcomes (PROs). |
Countries
United States
Contacts
CONTACTYonandy Barrientos
CONTACTMarissa M Puccio
Outcome results
None listed