Femoroacetabular Impingement Clinical Trial
Official title:
The Use of Patient-Specific 3D Printed Anatomic Models in Pre-Operative Planning and Patient Engagement to Improve Hip Arthroscopy Outcomes
Verified date | September 2021 |
Source | The Hawkins Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | April 16, 2021 |
Est. primary completion date | April 16, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Steadman Hawkins Clinic of the Carolinas - Greenville Health System | Greenville | South Carolina |
Lead Sponsor | Collaborator |
---|---|
The Hawkins Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resection Measurement Variations | The surgeon will make estimates of resection for the femoroplasty and acetabuloplasty based on standard pre-operative imaging (in millimeters). The surgeon will also make estimates based on the 3D model/3D printing measurements. Actual resection measurements will be collected intra-operatively and compared to the surgeon's pre-operative predictions based on the 3D model and the standard imaging techniques (in millimeters). | Pre-operative through date of surgery: Resection measurements will be collected intra-operatively and compared to the pre-operative estimations. |
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