Mako-MORE Registry

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

First listed

Jun 15, 2026

Start date

Jul 13, 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

• Yonandy Barrientos
  347-281-3196
  [email protected]
• Marissa M Puccio
  201-675-1416
  [email protected]

Locations (5)

Find similar trials in Jacksonville, FL

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