Two Year Study With Robotic-Arm Assisted Hip Surgery.

August 14, 2023 updated by: Matthew Dietz, MD, West Virginia University

A Two Year Multicenter Study of Robotic-Arm Assisted THA: Acetabular Cup Placement Accuracy and Clinical Outcomes

This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers. Specifically looking at acetabular cup placement during Total Hip Arthroplasty by either traditional or robotic-arm assisted placement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The incidence of dislocation following total hip arthroplasty (THA) has been reported to be from 1% to as much as 3.2%. The demand for THA is expected to increase. Post- dislocation solutions include closed reduction, open reduction, THA revision, and constrained cup, conversion to hemiarthroplasty, allograft or girdlestone resection. These solutions are often costly, painful and can involve substantial additional risks and complications. Acetabular cup placement is an important factor in the stability of the THA. Cup malpositioning has been associated with bearing surface ware and dislocation. For most patients, acceptable angles for abduction are 40° abduction (±10°) and 20° (±5°) version. However, malpositioning continues to occur resulting in cup angles outside acceptable ranges and leaving patients with an increased risk of dislocation.

This objective of this study is to examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26501
        • WVU Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients requiring primary total hip arthroplasty
  2. Patients willing and able to comply with follow-up requirements
  3. Patients willing to sign an Institutional Review Board approved informed consent form.

Exclusion Criteria:

  1. Patients with Body Mass Index >45
  2. Patients who are <18 years of age
  3. Patients with an active infection or suspected latent infection in or about the hip joint
  4. Bone stock that is inadequate for support or fixation of the prosthesis
  5. Previous major hip surgery excluding hip arthroscopy
  6. Total hip arthroplasty using cement fixation or resurfacing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Traditional THA.
Active Comparator: Intervention
Robotic-arm assisted THA.
Procedure: Robotic-Arm Assisted THA
The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version.
Time Frame: 6 months
Accuracy of cup placement will be measured by absolute value of degrees from target version (40 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.
6 months
Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period.
Time Frame: 1 Year
The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process . To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up.
1 Year
Change in "Patient-Reported Outcomes Measurement Information System" (PROMIS) Survey Over a 1 Year Period.
Time Frame: 1year

The PROMIS Global-10 is a global health quality of life patient reported outcome tool. It is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It measures symptoms, functioning, and healthcare quality of life for a wide variety of conditions. The PROMIS Global-10 consists of 10 questions assessing physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. 7 questions inquire about health in "general" and 3 questions assess emotional problems, fatigue and pain in the last 7 days.

PROMIS 10 Global Physical Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse physical health and 20 equals the best physical health). PROMIS 10 Global Mental Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse mental health and 20 equals the best mental health)
1year
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination.
Time Frame: 6 months
Accuracy of cup placement will be measured by absolute value of degrees from target inclination (20 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.
6 months
Adherence to Lewinnek Safe Zone
Time Frame: 6 month
5-25 degrees of anteversion; 30-50 degrees of inclination.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Collaborators

West Penn Allegheny Health System
Stryker Nordic

Investigators

  • Principal Investigator: Matthew J Dietz, MD, West Virginia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2019

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1808218345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All patient outcomes data will be entered by the on-site research assistant into the REDCap study site created and managed at the Principal Investigators institution by the primary research coordinator. The REDCap site will house the study data and provide a means for the remote site research assistant to enter patient demographics, medical history, surgical details and outcome results. Medical history, demographic, and surgical details.

IPD Sharing Time Frame

The individual participant data (IPD) will be available from the beginning of enrollment until the manuscript is submitted and accepted

IPD Sharing Access Criteria

the study will utilize a digital imaging analysis program called the Martell Hip Analysis Suite (HAS, Chicago, IL) as well as Computed Tomography (CT) scans. Patient reported outcomes (HOOS, PROMIS10, Hip stability and return to function) will also be collected at specified intervals. Using CT Scans and HAS analysis allows for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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