Robot arm aims to perfect hip implant angles

NCT ID NCT05497206

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Oct 13, 2026 · Last updated Oct 14, 2026 · Updated 1 time

Summary

Researchers are testing whether a robotic-arm surgical assistant helps surgeons place hip replacement implants within a target alignment range. The study enrolls adults with hip osteoarthritis or avascular necrosis who are scheduled for a direct anterior total hip replacement. Surgeons use the ROSA Hip System with fluoroscopic guidance, and researchers measure how often the implant angle falls inside the Callanan safe zone. They also track safety and patient-reported hip function.

What this could mean

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

Active substance
Robotic-arm surgical assistant (ROSA Hip System) used during total hip replacement
What this could lead to
If the robotic assistant places implants more accurately, it could lead to more consistent hip replacement outcomes and fewer revision surgeries.
What could go wrong
This is a small, single-arm study without a comparison group, so it cannot prove the robot is better than standard surgery. Results may not apply to all patients or surgeons.

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

12 people

The number who actually took part.

Started

Jun 2024

Finished

Dec 2024

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

Operative primary total hip arthroplasty candidates

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Age 18 - 80 years 2. Body mass index ≤40 (BMI = kg/m2) 3. Patient is willing and able to provide informed consent 4. Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis or avascular necrosis of the hip based on Investigator's clinical judgment 5. Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System Exclusion: 1. Has undergone an orthopaedic procedure of the spine or lower extremity, or is currently participating in a pain management clinical study of any joint, within the last 6 months or planned within the next 6 months 2. Patients receiving simultaneous bilateral hip arthroplasties are excluded from participation in this study; as well as any participants with staged bilateral arthroplasties within 6 months of each other 3. Active infection, sepsis, osteomyelitis 4. Patient is at a high risk for dislocation including those with long-segment spinal fusions (\>3 levels) and neuromuscular disorders 5. Inflammatory (rheumatoid or psoriatic arthritis) or post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis 6. Would, in the Investigator's opinion, be unwilling or unable to comply with the postoperative follow-up schedule 7. Patient is considered a member of a vulnerable population (pregnant, prisoner, mentally incompetent, etc.) 8. Previous hardware in the proximal femur or acetabulum from a prior orthopaedic procedure

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mosaic Life Care

    Saint Joseph, Missouri, 64507, United States

  • The Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

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