Mako-MORE Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStryker Orthopaedics
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mako Robotic-Arm Assisted Arthroplasty
Treatment groups
950 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
5Mayo Clinic (Jacksonville)32224, JacksonvilleFlorida, United States
UofL Health40202, LouisvilleKentucky, United States
NYU Langone Orthopedic Hospital10003, New YorkNew York, United States
Cleveland Clinic44195, ClevelandOhio, United States
Sponsors and collaborators
Stryker Orthopaedics
Lead sponsor
Source ClinicalTrials.gov