Clinical trials related to Knee Replacement Procedure
A Prospective, Multi-center, Post-market, Registry-based Evaluation of the Clinical Outcomes in Patients Receiving a Stryker Implant With Use of the Mako Robotic-Arm Assisted System (Mako-MORE)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
Mayo Clinic (Jacksonville)
NOT_YET_RECRUITING
Jacksonville
Kentucky
UofL Health
RECRUITING
Louisville
New York
NYU Langone Orthopedic Hospital
RECRUITING
New York
Ohio
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
Rhode Island
Robotic Joint Replacement Institute - Ortho Rhode Island
NOT_YET_RECRUITING
Wakefield
Contact Information
Primary
Yonandy Barrientos
yonandy.barrientos@stryker.com
347-281-3196
Backup
Marissa M Puccio
marissa.puccio@stryker.com
201-675-1416
Time Frame
Start Date:2026-07-13
Estimated Completion Date:2037-03-15
Participants
Target number of participants:950
Treatments
5.0 THA (Primary)
This cohort includes patients undergoing primary total hip arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (THA 5.0 application).
5.0 THA (Revision)
This cohort includes patients undergoing revision total hip arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (THA 5.0 application).
3.0 TKA (Primary)
This cohort includes patients undergoing primary total knee arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (TKA 3.0 application).
3.1 PKA (Primary)
This cohort includes patients undergoing primary partial knee arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (PKA 3.1 application).
Manual THA (Primary)
This cohort includes patients undergoing primary total hip arthroplasty performed using manual surgical instrumentation, without robotic assistance.
Manual TKA (Primary)
This cohort includes patients undergoing primary total knee arthroplasty performed using manual surgical instrumentation, without robotic assistance.