Real Time 3D Imaging and Surrogate Bone Model

February 15, 2017 updated by: The Cleveland Clinic

Comparison of Acetabular Shell Position Using 3D Planning vs. Standard Preoperative Planning: A Randomized Clinical Trial

This is an observer-blinded prospective randomized clinical trial to define the efficacy of a new technology developed at the Cleveland Clinic to improve the positioning of the acetabular shell in total hip arthroplasty.The proposed study will enroll patients that have consented to total hip arthroplasty with or without screw fixation for treatment of hip pathology. This treatment is standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. The only difference in treatment between the groups will be the use of a surrogate bone model to help assist the surgeon visualize the ideal placement of the acetabular component. Diagnostic testing performed specifically related to this study consists of obtaining one pre-operative and one post-operative CT scan. The post-operative scan is to be performed within two weeks of surgery.

The investigators predict that those patients with 3D imaging and bone model will have better acetabular shell placement than those with standard preoperative planning.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The plan is enroll 44 subjects (22 in the standard surgery group and 22 in the experimental surgical group) into this randomized clinical trial. All subjects will have the standard of care indications for THA and will give informed consent for both the surgery and participation in this study. Enrollment will occur as part of the routine office evaluation and will be obtained by the treating surgeon or by the research assistant. Four surgeons (Wael Barsoum, Trevor Murray, Carlos Higuera, and Michael Bloomfield) with surgical experience in total hip arthroplasty will perform the procedures in this study. All subjects within each surgeon's practice who qualify for participation in this study will be approached. Subjects will be enrolled at least 10 days prior to the date of surgery. Ten days is the minimum time necessary to obtain a pre-operative CT scan for surgical planning and to manufacture the surrogate bone model. Patients who are not approached during regular office visits will be contacted by phone and if they are interested, they will be scheduled to arrive to the radiology department to sign the informed consent and receive the preoperative CT scan. Subjects will be randomized into either the experimental or control group at the time of consent by the study coordinator. Subjects in the experimental group will have their pre-operative planning done using the 3D surgical simulator and surrogate bone model will be available for the surgeon during surgery. Subjects in the control group will have their pre-operative planning done using plain film x-ray and two-dimensional (2D) templates.

Eligible subjects for inclusion in the study will be able to receive a pelvic CT scan at the Cleveland Clinic. Additionally, we will obtain standard of care pre- and post-operative x-rays (AP view). For subjects randomized into the experimental group, their CT scan DICOM images will be uploaded into the Cleveland Clinic developed surgical simulator specifically designed for THA at least 10 days prior to surgery. For each experimental subject, the Cleveland Clinic pre-operative planning software will be used to define the optimal size and location of the acetabular components (acetabular shell, and the ultra-high molecular weight polyethylene bearing - UHMWPE). The treating surgeon will virtually place the implant in the simulator software. The specification for shell placement will vary depending on the subject's individual pathology and pelvic morphology, but is expected to fall within the range of 10-35 degrees of anteversion and 30-50 degrees of abduction.

In the control group, each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays. To prepare the acetabulum and place the implants on the day of surgery, surgeons will use standard surgical alignment instruments provided by the manufacturer of the implant. For the experimental group, the surgeon will use CT scan and a 3D preoperative planning software to place the implants virtually. The surgeons are provided with a surrogate bone model with a fabricated acetabular implant placed in the same orientation as was planned in the surgical simulator software, and will use standard surgical instruments provided by the manufacturer of the implant.

The images obtained from the post-operative CT scans will be uploaded into the simulator software for 3D reconstruction. The 3D image of the post-operative pelvis with the implants will be superimposed onto the image of the pre-operative pelvis with the virtually placed implants. Using measurement tools within the software we will compare the position of the actual acetabular component placed in the patient with the desired position specified by the plan. The measurements that will be made are for angular orientations in 3D space (anteversion and inclination). Measurements are accurate to within a fraction of a degree.

Study Type

Interventional

Enrollment (Actual)

36

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
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria:
  • Primary, unilateral Total hip arthroplasty (THA)
  • 18 to 85 years old at time of surgery
  • Able to get a pre- and post-operative CT scan at the Cleveland Clinic Main Campus at least 10 days prior to surgery

Exclusion Criteria:

  • Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator.
  • Pregnancy
  • Incarceration
  • Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D imaging, surrogate bone model
3D imaging & surrogate bone model
Device: 3D imaging & surrogate bone model
3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging
No Intervention: Standard of Care Preoperative Imaging
Patients receiving standard of care preoperative planning prior to total hip arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acetabular Shell Version and Inclination
Time Frame: within 2 weeks of surgery
A CT scan of all patients will be obtained within 2 weeks of surgery to measure placement (acetabular version & inclination measured in degrees) of the acetabular shell
within 2 weeks of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Time
Time Frame: time of surgery
Duration of the surgical case
time of surgery

Collaborators and Investigators

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

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Carlos Higuera, MD, The Cleveland Clinic
  • Study Director: Alison Klika, MS, The Cleveland Clinic

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

Helpful Links

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

June 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

July 29, 2014

First Posted (Estimate)

July 30, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

February 15, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-555

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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