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Robot-Assisted joint surgery under the microscope: will it help implants last longer?

NCT ID NCT07647354

Knowledge-focused Sponsor: Stryker Orthopaedics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This study will follow about 950 people who receive hip or knee replacements using Stryker implants, some with the Mako robotic-arm system and some without. Researchers will track how long the implants last and how well patients feel and function over five years. The goal is to gather real-world data on whether robotic assistance improves outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mako Robotic-Arm Assisted System (surgical device)
What this could lead to
If successful, this study could provide real-world evidence on whether robotic-arm assistance improves implant longevity and patient outcomes after joint replacement.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by surgeon skill or patient selection, and long-term follow-up may have dropouts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 950 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Mar 2037

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, hip osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthropathy of hip Arthropathy of knee

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Mayo Clinic (Jacksonville)

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32224, United States

  • NYU Langone Orthopedic Hospital

    RECRUITING

    New York, New York, 10003, United States

  • Robotic Joint Replacement Institute - Ortho Rhode Island

    NOT_YET_RECRUITING

    Wakefield, Rhode Island, 02879, United States

  • UofL Health

    RECRUITING

    Louisville, Kentucky, 40202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.