Femoroacetabular ImpingementNCT03995290
3D Modeling to Improve Hip Arthroscopy Outcomes
An observational study of Femoroacetabular Impingement, run by The Hawkins Foundation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- 3D Hip Model from Pre-operative CT scan
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 16 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Greenville, South Carolina, 29615
About this study
Official title: The Use of Patient-Specific 3D Printed Anatomic Models in Pre-Operative Planning and Patient Engagement to Improve Hip Arthroscopy Outcomes
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.
Read the 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.
- Conditions
- Femoroacetabular Impingement
- Being tested
- 3D Hip Model from Pre-operative CT scan
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Hip Model from Pre-operative CT scanOther
A printed 3D model will be created based off of the patient's standard of care preoperative CT scan.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Pre-operative through date of surgery: Resection measurements will be collected intra-operatively and compared to the pre-operative estimations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start1 Nov 2020
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Why it stopped: Loss of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995290
- Sponsor's protocol ID
- Pro00086834
- Status last verified
- Sep 2021
- First submitted
- 18 Jun 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Patient-Specific 3D Printed Anatomic Models in Pre-Operative Planning and Patient Engagement to Improve Hip Arthroscopy Outcomes
- ClinicalTrials.gov ID
- NCT03995290
- Acronym / sponsor ID
- Pro00086834
- Conditions
- Femoroacetabular Impingement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Loss of funding.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Hip Model from Pre-operative CT scanA printed 3D model will be created based off of the patient's standard of care preoperative CT scan. | Other | – |
Primary outcome
Resection Measurement Variations
Time frame: Pre-operative through date of surgery: Resection measurements will be collected intra-operatively and compared to the pre-operative estimations.
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).
Results and safety
The study was stopped early (reason given: Loss of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoroacetabular Impingement, run by The Hawkins Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Loss of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resection Measurement Variations (time frame: Pre-operative through date of surgery: Resection measurements will be collected intra-operatively and compared to the pre-operative estimations.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.