Mako-MORE Registry
August 14, 2026 updated by: Stryker Orthopaedics
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)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The Mako-MORE Registry is a prospective, post-market, multi-center registry-based evaluation of the Mako Robotic-Arm Assisted System used in total hip arthroplasty (primary and revision), total knee arthroplasty, and partial knee arthroplasty. The registry includes both Mako-assisted and manual arthroplasty cohorts to support real-world data collection.
Eligible patients undergoing arthroplasty using cleared Mako SmartRobotics™ applications or manual procedures will be enrolled and followed according to standard-of-care clinical practice. Data collected include demographics, procedural details, patient-reported outcomes, health utility measures, radiographic imaging, and adverse event information. Follow-up assessments will occur from the preoperative period through five years postoperatively.
The primary purpose of the registry is observational and descriptive. No investigational devices or experimental interventions are used, and all procedures are performed in accordance with FDA-cleared labeling and institutional standards of care.
Study Type
Observational
Enrollment (Estimated)
950
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yonandy Barrientos
- Phone Number: 347-281-3196
- Email: yonandy.barrientos@stryker.com
Study Contact Backup
- Name: Marissa M Puccio
- Phone Number: 201-675-1416
- Email: marissa.puccio@stryker.com
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Not yet recruiting
- Mayo Clinic (Jacksonville)
-
Contact:
- Bre Jenkins, MPH
- Email: Jenkins.Breana@mayo.edu
-
Principal Investigator:
- Bryan D. Springer, MD
-
Contact:
- Lauren Evans, DPT
- Phone Number: 904-953-5416
- Email: Evans.Lauren2@mayo.edu
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Recruiting
- UofL Health
-
Principal Investigator:
- Arthur Malkani, MD
-
Contact:
- Langan Smith
- Phone Number: 65585 502-587-8222
- Email: langan.smith@uoflhealth.org
-
-
New York
-
New York, New York, United States, 10003
- Recruiting
- NYU Langone Orthopedic Hospital
-
Principal Investigator:
- Joshua Rozell, MD
-
Sub-Investigator:
- Matthew Hepinstall, MD
-
Contact:
- Stephanie Frezzo, MHA
- Phone Number: 9172277486
- Email: stephanie.Frezzo@nyulangone.org
-
Contact:
- Daniel Warren, MSPH
- Phone Number: 954-559-2251
- Email: daniel.warren@nyulangone.org
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Not yet recruiting
- Cleveland Clinic
-
Contact:
- Laura Stiegel
- Email: stiegel@ccf.org
-
Principal Investigator:
- Nicolas S Piuzzi, MD
-
Contact:
- Sanalkumar Krishnan, Ph.D.
- Phone Number: 216-445-7194
- Email: KRISHNS11@ccf.org
-
-
Rhode Island
-
Wakefield, Rhode Island, United States, 02879
- Not yet recruiting
- Robotic Joint Replacement Institute - Ortho Rhode Island
-
Principal Investigator:
- Robert Marchand, MD
-
Contact:
- Kelly Taylor, BSN, RN
- Phone Number: 2260 401-777-7000
- Email: ktaylor@orthopedicsri.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study 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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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).
|
This 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.
Other Names:
|
|
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).
|
This 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.
Other Names:
|
|
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).
|
This 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.
Other Names:
|
|
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).
|
This 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.
Other Names:
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Survivorship at 2 Years Postoperative
Time Frame: 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.
|
2-years postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Survivorship at 5 Years Postoperative
Time Frame: 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.
|
5-years postoperative
|
|
Change in Patient-Reported Outcomes From Baseline
Time Frame: 5-years postoperative
|
To evaluate changes between preoperative and postoperative patient reported outcomes (PROs).
|
5-years postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2026
Primary Completion (Estimated)
May 15, 2033
Study Completion (Estimated)
March 15, 2037
Study Registration Dates
First Submitted
June 9, 2026
First Submitted That Met QC Criteria
June 9, 2026
First Posted (Actual)
June 15, 2026
Study Record Updates
Last Update Posted (Actual)
August 18, 2026
Last Update Submitted That Met QC Criteria
August 14, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 113 (Shenzhen Universisty general hospital)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.