Mako-MORE Registry

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Stryker Orthopaedics
Study ID
NCT07647354
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Arthropathy of Hip
  • Arthropathy of Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
May 15, 2033
Completion
Mar 15, 2037

Study Design

Enrollment
950 participants (estimated)

Arms

  • Arm: 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).
  • Arm: 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).
  • Arm: 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).
  • Arm: 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).
  • Arm: Manual THA (Primary)
    This cohort includes patients undergoing primary total hip arthroplasty performed using manual surgical instrumentation, without robotic assistance.
  • Arm: Manual TKA (Primary)
    This cohort includes patients undergoing primary total knee arthroplasty performed using manual surgical instrumentation, without robotic assistance.

Primary Outcome Measure

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

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic (Jacksonville)JacksonvilleFlorida32224
Lauren Evans, DPT
[email protected]
9049535416
Bre Jenkins, MPH
[email protected]
Bryan D. Springer, MD (PRINCIPAL_INVESTIGATOR)
UofL HealthLouisvilleKentucky40202
Langan Smith
[email protected]
5025878222
Arthur Malkani, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone Orthopedic HospitalNew YorkNew York10003
Daniel Warren, MSPH
[email protected]
9545592251
Stephanie Frezzo, MHA
[email protected]
9172277486
Joshua Rozell, MD (PRINCIPAL_INVESTIGATOR)
Matthew Hepinstall, MD (SUB_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Sanalkumar Krishnan, Ph.D.
[email protected]
2164457194
Laura Stiegel
[email protected]
Nicolas S Piuzzi, MD (PRINCIPAL_INVESTIGATOR)
Ortho Rhode IslandWakefieldRhode Island02879
Kelly Taylor, BSN, RN
[email protected]
4017777000
Robert Marchand, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By research site
Mayo Clinic (Jacksonville)· Jacksonville, FLUofL Health· Louisville, KYNYU Langone Orthopedic Hospital· New York, NYCleveland Clinic· Cleveland, OHOrtho Rhode Island· Wakefield, RI

Related Studies