Clinical trial NCT03995290: 3D Modeling to Improve Hip Arthroscopy Outcomes
Official title: The Use of Patient-Specific 3D Printed Anatomic Models in Pre-Operative Planning and Patient Engagement to Improve Hip Arthroscopy Outcomes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Femoroacetabular Impingement
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject will be approached for participation in this study after the subject has made the decision to undergo a hip arthroscopy procedure and will be receiving a standard of care hip CT Scan. Patients who meet all criteria will be offered enrollment into the study.

Brief summary: This study will pilot the use of 3D printed models of the hip, for use in pre-operative planning and patient communication to improve clinical outcomes and patient engagement. This method will be implemented in the setting of femoroacetabular impingement (FAI), with the goal of identifying and measuring specific anatomical pathologies and impingement (range of motion) risks, to communicate a pre-operative plan to both the surgical team, and the patient.

Detailed description: Following a standard of care pre-operative CT scan, a 3D rendering of the CT scan will be completed. The de-identified CT Scan data will be transferred to the Clemson University Bioengineering Department, and a 3D modeling software will convert it to a computer model that will then be 3D printed. During the doctor-patient pre-operative consultation, the 3D Printed model will be used to assist the doctor in describing the patient's pathology and upcoming surgical procedure. In this pilot study, the surgeon will make measurements and estimates of resection for the femoroplasty and acetabuloplasty off of 2D CT scan, MRI, and x-rays. This will then be compared quantitatively to the results of the 3D model/3D printing measurements. Surgeon debriefings will occur postoperatively to determine the benefit of the model and how well it matched up to what the surgeon experienced during the surgery.

FAI involves complex anatomic morphology which can be unique to each patient. A thorough understanding of the type and specifically location of impingement is paramount to successful results if surgery is required. 2D imaging has limitations when analyzing a 3D anatomic lesion. 3D printed hip models have the potential to provide superior preoperative planning and subsequent surgical results. In addition, 3D models can potentially improve patient understanding, expectations, and outcomes.

Eligibility criteria: Inclusion Criteria:

* Surgical candidate for a hip arthroscopy for the treatment of femoroacetabular impingement
* Subject is willing to sign the informed consent.
* Subject is at least 18 years of age.

Exclusion Criteria (n/a)

Primary outcomes:
measure: Resection Measurement Variations
timeFrame: Pre-operative through date of surgery: Resection measurements will be collected intra-operatively and compared to the pre-operative estimations.
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas - Greenville Health System
state: South Carolina
Study officials:
References: