Mako-MORE Registry
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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 population
The subject population enrolled within the study is reflective of the anticipated real-world patients who would be appropriate candidates for treatment using Mako SmartRobotics™ applications and indications or manual surgery, depending on the relevant study cohorts
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mako Robotic-Arm Assisted Arthroplasty
DeviceThis 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.
Treatment groups
950 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: 5.0 THA (Primary)1 intervention
Group B: 5.0 THA (Revision)1 intervention
Group C: 3.0 TKA (Primary)1 intervention
Group D: 3.1 PKA (Primary)1 intervention
Group E: Manual THA (Primary)0 interventions
Group F: Manual TKA (Primary)0 interventions
Trial outcomes
Primary outcomes
1
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 postoperativeSecondary outcomes
1
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 postoperative2
Change in Patient-Reported Outcomes From Baseline
To evaluate changes between preoperative and postoperative patient reported outcomes (PROs).
Time frame
5-years postoperativeSponsors and contacts
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Source ClinicalTrials.gov