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NCT07647354
Mako-MORE Registry
Conditions: Arthropathy of Knee, Arthropathy of Hip
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 950
Sponsor: Stryker Orthopaedics
Location: Mayo Clinic (Jacksonville) Jacksonville Florida
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07647354). StuddyBuddy aggregates publicly available trial information.