Trial Outcomes & Findings for Real Time 3D Imaging and Surrogate Bone Model (NCT NCT02204007)

NCT ID: NCT02204007

Last Updated: 2017-03-29

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: within 2 weeks of surgery
• Results posted on: 2017-03-29

Participant Flow

Participant milestones

Measure	3D Imaging, Surrogate Bone Model 3D imaging \& surrogate bone model 3D imaging \& surrogate bone model: 3D imaging \& surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging	Standard of Care Preoperative Imaging Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
Overall Study STARTED	18	18
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	3D Imaging, Surrogate Bone Model 3D imaging \& surrogate bone model 3D imaging \& surrogate bone model: 3D imaging \& surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging	Standard of Care Preoperative Imaging Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
Overall Study Surgery Canceled	1	1

Baseline Characteristics

Real Time 3D Imaging and Surrogate Bone Model

Baseline characteristics by cohort

Measure	3D Imaging, Surrogate Bone Model n=17 Participants 3D imaging \& surrogate bone model 3D imaging \& surrogate bone model: 3D imaging \& surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging	Standard of Care Preoperative Imaging n=17 Participants Patients receiving standard of care preoperative planning prior to total hip arthroplasty.	Total n=34 Participants Total of all reporting groups
Age, Continuous	65.4 years n=5 Participants	58.6 years n=7 Participants	62.0 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	3D Imaging, Surrogate Bone Model n=14 Participants 3D imaging \& surrogate bone model 3D imaging \& surrogate bone model: 3D imaging \& surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging	Standard of Care Preoperative Imaging n=11 Participants Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
Acetabular Shell Version and Inclination Anteversion	27.1 degrees Interval 9.0 to 48.0	23.3 degrees Interval 9.0 to 37.0
Acetabular Shell Version and Inclination Inclination	43.4 degrees Interval 34.0 to 54.0	39.3 degrees Interval 27.0 to 55.0

SECONDARY outcome

Timeframe: time of surgery

Duration of the surgical case

Outcome measures

Measure	3D Imaging, Surrogate Bone Model n=14 Participants 3D imaging \& surrogate bone model 3D imaging \& surrogate bone model: 3D imaging \& surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging	Standard of Care Preoperative Imaging n=11 Participants Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
Operative Time	128.9 minutes Interval 76.0 to 179.0	151.2 minutes Interval 82.0 to 291.0

Adverse Events

3D Imaging, Surrogate Bone Model

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Preoperative Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carlos A Higuera, MD

Cleveland Clinic Foundation

Phone: 2166361136

Email: higuerc@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place