Arthropathy of KneeNCT07647354
Mako-MORE Registry
An observational study of Arthropathy of Knee and Arthropathy of Hip, run by Stryker Orthopaedics at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthropathy of Knee, Arthropathy of Hip
- What is being tested?
- Mako Robotic-Arm Assisted Arthroplasty
- Type of treatment
- Medical device
- How many people
- 950 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Jul 2026to 15 Mar 2037
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Sanalkumar Krishnan, Ph.D., 216-445-7194, KRISHNS11@ccf.org
Laura Stiegel, stiegel@ccf.org
- Not yet recruiting
Mayo Clinic (Jacksonville)
Jacksonville, Florida, 32224
Lauren Evans, DPT, 904-953-5416, Evans.Lauren2@mayo.edu
Bre Jenkins, MPH, Jenkins.Breana@mayo.edu
- Recruiting
UofL Health
Louisville, Kentucky, 40202
Langan Smith, 502-587-8222 ext. 65585, langan.smith@uoflhealth.org
Arthur Malkani, MD
- Recruiting
NYU Langone Orthopedic Hospital
New York, New York, 10003
Daniel Warren, MSPH, 954-559-2251, daniel.warren@nyulangone.org
Stephanie Frezzo, MHA, 9172277486, stephanie.Frezzo@nyulangone.org
- Not yet recruiting
Robotic Joint Replacement Institute - Ortho Rhode Island
Wakefield, Rhode Island, 02879
Kelly Taylor, BSN, RN, 401-777-7000 ext. 2260, ktaylor@orthopedicsri.com
Robert Marchand, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthropathy of Knee, Arthropathy of Hip
- Being tested
- Mako Robotic-Arm Assisted Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mako Robotic-Arm Assisted ArthroplastyDevice
Also called Mako SmartRobotics™ System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Mako Robotic-Arm Assisted Arthroplasty | |
| 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). Receives: Device: Mako Robotic-Arm Assisted Arthroplasty | |
| 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). Receives: Device: Mako Robotic-Arm Assisted Arthroplasty | |
| 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). Receives: Device: Mako Robotic-Arm Assisted Arthroplasty | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-years postoperative
Secondary outcomes (2)
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.
Measured: 5-years postoperative
Change in Patient-Reported Outcomes From Baseline
To evaluate changes between preoperative and postoperative patient reported outcomes (PROs).
Measured: 5-years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start13 Jul 2026
- Primary completion15 May 2033 (estimated)
- Study completion15 Mar 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 950 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647354
- Sponsor's protocol ID
- 113
- Status last verified
- May 2026
- First submitted
- 9 Jun 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07647354
- Acronym / sponsor ID
- 113
- Conditions
- Arthropathy of Knee, Arthropathy of Hip
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 15 May 2033 (estimated)
- Study completion
- 15 Mar 2037 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 5.0 THA (Primary) | – | Device: Mako Robotic-Arm Assisted ArthroplastyThis 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) | – | Device: Mako Robotic-Arm Assisted ArthroplastyThis 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) | – | Device: Mako Robotic-Arm Assisted ArthroplastyThis 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) | – | Device: Mako Robotic-Arm Assisted ArthroplastyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mako Robotic-Arm Assisted ArthroplastyAlso: Mako SmartRobotics™ SystemThis 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. | Device | 3.0 TKA (Primary), 3.1 PKA (Primary), 5.0 THA (Primary), 5.0 THA (Revision) |
Primary outcome
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 secondary outcomes
Implant Survivorship at 5 Years Postoperative
Time frame: 5-years postoperative
Change in Patient-Reported Outcomes From Baseline
Time frame: 5-years postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy of Knee and Arthropathy of Hip, run by Stryker Orthopaedics at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yonandy Barrientos (347-281-3196, yonandy.barrientos@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survivorship at 2 Years Postoperative (time frame: 2-years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.