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Robotic Arm-assisted Surgery

Robotic Arm-Assisted Surgery for Hip Conditions

N/A

Waitlist Available

Led By Benjamin G Domb, MD

Research Sponsored by American Hip Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperatively and postoperatively at 6 weeks and 1 year

Awards & highlights

Study Summary

This trial is testing a new robotic system to see how precise and accurate it is.

Who is the study for?

This trial is for adults over 18 needing hip replacement surgery due to conditions like Hip Dysplasia or Osteoarthritis. Participants must be able to follow post-surgery check-ups and sign a consent form. It's not for those with infections near the joint, BMI over 40, neuromuscular disorders, muscle atrophy, poor blood supply in the limb, Ankylosing spondylitis, or inadequate bone stock.Check my eligibility

What is being tested?

The study tests the MAKO THA 4.0 System—a robotic arm-assisted device—to see how precise and accurate it is during hip replacement surgeries across multiple centers using new software.See study design

What are the potential side effects?

While specific side effects are not listed for this device trial, typical risks of robotic-assisted surgery may include pain at the incision site, bleeding, infection risk similar to traditional surgery methods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperatively and postoperatively at 6 weeks and 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperatively and postoperatively at 6 weeks and 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperatively and postoperatively at 6 weeks and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Computed Tomography scan. Placement accuracy of acetabular cup and femoral stem

Secondary outcome measures

Forgotten Joint Score

Harris Hip Score

Hip Disability and Osteoarthritis Outcome Score

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mako THA 4.0 groupExperimental Treatment1 Intervention

Hip system used: femoral stem (Accolade II), acetabular cup (Trident II or MDM if necessary), femoral head (ceramic or metal head compatible with Accolade II), acetabular insert (X3 Trident II or MDM liner when using MDM cup). Mako THA 4.0 software also will be used.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkOTHER

243 Previous Clinical Trials

59,329 Total Patients Enrolled

1 Trials studying Hip Dysplasia

American Hip InstituteLead Sponsor

3 Previous Clinical Trials

150 Total Patients Enrolled

Stryker OrthopaedicsIndustry Sponsor

77 Previous Clinical Trials

20,198 Total Patients Enrolled

Media Library

MAKO THA 4.0 System (Robotic Arm-assisted Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT04646096 — N/A

Hip Dysplasia Research Study Groups: Mako THA 4.0 group

Hip Dysplasia Clinical Trial 2023: MAKO THA 4.0 System Highlights & Side Effects. Trial Name: NCT04646096 — N/A

MAKO THA 4.0 System (Robotic Arm-assisted Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04646096 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial still open to the public?

"The information posted on clinicaltrials.gov indicates that the trial is no longer seeking patients; initial recruitment began January 1st 2021 and was last amended August 17th 2021. However, many other research projects are actively recruiting at this time with 97 listings in total."

Answered by AI