Recruiting

Observational Study

Sponsor:

Stryker Orthopaedics

Code:

NCT07647354

Conditions

Arthropathy of Knee

Arthropathy of Hip

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mako Robotic-Arm Assisted Arthroplasty

Study Details

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

Study ID

NCT07647354

Start date

Jul 13, 2026

Status verified date

May, 2026

Completion date

Mar 15, 2037

Anticipated

Primary completion date

May 15, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

950 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Mako Robotic-Arm Assisted Arthroplasty

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.

Primary outcome measure

  • Implant Survivorship at 2 Years Postoperative [ Time Frame: 2-years postoperative ]

Central Contacts and Locations

Central contacts

Yonandy Barrientos

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

Marissa M Puccio

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

Locations

UofL Health

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Langan Smith

502-587-8222langan.smith@uoflhealth.org

Principal Investigator:

Arthur Malkani, MD

NYU Langone Orthopedic Hospital

Recruiting

New York, New York, United States, 10003

Contacts

Daniel Warren, MSPH

954-559-2251daniel.warren@nyulangone.org

Stephanie Frezzo, MHA

9172277486stephanie.Frezzo@nyulangone.org

Principal Investigator:

Joshua Rozell, MD

More Information

Sponsor

Stryker Orthopaedics

Last update posted

Aug 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stryker Orthopaedics on 2026-08-18.