An interventional study of 3D imaging & surrogate bone model in Arthritis, sponsored by The Cleveland Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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.
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 36 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
3D imaging \& surrogate bone model
Device: 3D imaging & surrogate bone model
Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
3D imaging \& surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging
Acetabular Shell Version and Inclination
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
Time frame: within 2 weeks of surgery
Operative Time
Duration of the surgical case
Time frame: time of surgery
| Milestone | 3D Imaging, Surrogate Bone Model | Standard of Care Preoperative Imaging |
|---|---|---|
| Started | 18 | 18 |
| Completed | 17 | 17 |
| Not completed | 1 | 1 |
| Withdrew: Surgery canceled | 1 | 1 |
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
| degrees | 3D Imaging, Surrogate Bone Model | Standard of Care Preoperative Imaging |
|---|---|---|
| Inclination | 43.4 (34 to 54) | 39.3 (27 to 55) |
| Anteversion | 27.1 (9 to 48) | 23.3 (9 to 37) |
Duration of the surgical case
| minutes | 3D Imaging, Surrogate Bone Model | Standard of Care Preoperative Imaging |
|---|---|---|
| Operative Time | 128.9 (76 to 179) | 151.2 (82 to 291) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 3D Imaging, Surrogate Bone Model | — | 0/17 (0%) | 0/17 (0%) |
| Standard of Care Preoperative Imaging | — | 0/17 (0%) | 0/17 (0%) |
| Age, Continuous(years) | 3D Imaging, Surrogate Bone Model | Standard of Care Preoperative Imaging | Total |
|---|---|---|---|
| Mean | 65.4 (44 to 80) | 58.6 (41 to 82) | 62.0 (41 to 82) |
| Sex: Female, Male(Participants) | 3D Imaging, Surrogate Bone Model | Standard of Care Preoperative Imaging | Total |
|---|---|---|---|
| Female | 9 | 5 | 14 |
| Male | 8 | 12 | 20 |
Plan to share: No
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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