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.
Sponsors and collaborators
Source ClinicalTrials.gov