Mako-MORE Registry

NCT07647354 | Not Yet Recruiting FDA Device

• 1 other identifier: 113
• Study Type: observational
• Target: 950
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Arthropathy of Knee; Arthropathy of Hip

Outcome Measures

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.

  2-years postoperative

Secondary Outcomes (2)

• Implant Survivorship at 5 Years Postoperative

  5-years postoperative

• Change in Patient-Reported Outcomes From Baseline

  5-years postoperative

Study Arms (6)

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).

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).

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).

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).

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.

Interventions

Mako Robotic-Arm Assisted Arthroplasty DEVICE

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.

Also known as: Mako SmartRobotics™ System

3.0 TKA (Primary); 3.1 PKA (Primary); 5.0 THA (Primary); 5.0 THA (Revision)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (5)

Mayo Clinic (Jacksonville)

Jacksonville, Florida, 32224, United States

Location

UofL Health

Louisville, Kentucky, 40202, United States

Location

NYU Langone Orthopedic Hospital

New York, New York, 10003, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ortho Rhode Island

Wakefield, Rhode Island, 02879, United States

Location

Central Study Contacts

Yonandy Barrientos

CONTACT

347-281-3196; yonandy.barrientos@stryker.com

Marissa M Puccio

CONTACT

201-675-1416; marissa.puccio@stryker.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): May 15, 2033
• Study Completion (Estimated): March 15, 2037
• Last Updated: June 15, 2026

Record last verified: 2026-05

Locations

US (5)