Femoro Acetabular ImpingementNCT04505020
The Innovation of 3D Printing for Preoperative Planning in Hip Preservation Surgery
A study testing 3D Print + Conventional imaging and Conventional imaging in people with Femoro Acetabular Impingement, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
This is a randomized controlled trial (RCT) to evaluate the introduction of a 3D printed model into the pre and intra-operative planning for arthroscopic femoroacetabular impingement (FAI) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoro Acetabular Impingement
- What is being tested?
- 3D Print + Conventional imaging and Conventional imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2021to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiological proven diagnosis of cam-type femoroacetabular impingement (FAI)
Who cannot join
- Patients with advanced arthritis (Tonnis Grade III or Kellgren-Lawrence Grade III or IV or evidence of less than 2 mm of joint space, as determined by conventional radiographs.)
- Patients with 1cm2 (or greater) of cartilage delamination in the hip
- Patients with type III or IV heterotopic ossification
- Patients with avascular necrosis
- Patients who are unable to provide informed consent
- Patients who are undergoing revision hip arthroscopy
Show all 11Show fewer
- Patients who are pregnant
- Patients who have the presence of local or systemic infection
- Patients with an inability to cooperate with and/or comprehend post-operative instructions
- Patients with nonvascular surgical sites (MRI proven)
- Patients with cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
5955 Veterans' Memorial Lane Room 2106, VMB
Halifax, Nova Scotia, B3H 2E1
About this study
This is a randomized controlled trial (RCT) to evaluate the introduction of a 3D printed model into the pre and intra-operative planning for arthroscopic femoroacetabular impingement (FAI) surgery. The RCT will look to place patients into one of two treatment groups: 1) conventional preoperative imaging (X-ray, CT, and MRI) only and 2) those that have had a 3D printed model created in addition to the conventional imaging.
Read the detailed description
In this study, we investigate the use of 3D models during pre and intra-operative planning could improve the success of hip arthroscopy and reduce the incidence of revision cases. By adding an adjunct to the common suite of pre-operative imaging modalities (X-ray, MRI and CT), we can change the surgeon's understanding of each patient's individual morphology with a tactile physical model. This study will compare the success of hip arthroscopy in patients with or without 3D printed models (in addition to traditional pre-operative imaging).
This will be a single-center, blinded observer, randomized controlled trial of 80 patients performed at the Halifax Infirmary, Queen Elizabeth II Health Sciences Center in Halifax, Nova Scotia. Patients with cam-type FAI involved in the study will be approached by the surgeon, Dr. Ivan Wong, or a delegate regarding the study during a pre-operative visit. Following a detailed discussion of the risks/benefits/alternatives of this study, the patient will be provided with a copy of the informed consent to review, if they demonstrate an interest in the study. If the patient wishes to be enrolled in the study, the research team will obtain patient consent for the study according to the Division of Orthopaedic Surgery and Nova Scotia Health Authority (NSHA) institutional protocols.
In the pre-operative period, there will be no additional time requirements for the participant, except for the informed consent process for the study. Routine X-ray radiographs, as well as a pre-operative MRI and CT scan, will be obtained for all subjects undergoing FAI surgery. The participants will not be exposed to any additional radiation. Subjects will complete a structured clinical examination conducted by a sports medicine fellowship-trained orthopaedic consultant. The patient will also complete pre-operative questionnaires.
Patients that have consented to the study will be randomized into two groups with a 50% chance of being in either group. Randomization will be done with a computer random number generator. Both groups will undergo routine pre-operative imaging but one group will also have a 3D print made from the 3D CT reconstruction. All patient groups will undergo hip arthroscopy for the treatment of their FAI.
- Conditions
- Femoro Acetabular Impingement
- Being tested
- 3D Print + Conventional imaging, Conventional imaging
- Keywords
- Femoroacetabular Impingement, Cam lesion, 3D printing, Pre-operative planning
- 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 Print + Conventional imagingOther
This group will have a 3D reconstruction of their hip printed using a 3D printer so that the PI can use it in their pre and intra-operative planning along with traditional imaging.
Conventional imagingOther
This group will have CT, MRI and X-Ray imaging completed so that the PI can use it in their pre and intra-operative planning.
| Study group | Role | What they receive |
|---|---|---|
| 3D Print + Conventional imaging | Experimental | Patients in this group allocation will receive a 3D reconstruction of their hip in addition to conventional preoperative imaging (X-ray, CT, and MRI) only for the use of pre-operative and intra-operative planning for their hip arthroscopy (FAI) procedure. Receives: Other: 3D Print + Conventional imaging |
| Conventional Imaging | Other | Patients in this group allocation will receive conventional preoperative imaging (X-ray, CT, and MRI) only for the use of pre-operative and intra-operative planning for their hip arthroscopy (FAI) procedure. Receives: Other: Conventional imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of CAM resection
Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.
Measured: Change in Pre-op measurements compared to 2 weeks post-operatively
Measure of CAM resection
Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.
Measured: Change in Pre-op measurements compared to 6 months post-operatively
Measure of CAM resection
Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.
Measured: Change in Pre-op measurements compared to 24 months post-operatively
Secondary outcomes (7)
Differences in post-operative patient reported outcomes: iHOT-33
The secondary outcome is the differences in post-operative patient reported outcomes for the international hip outcome tool (iHOT-33) when compared to a pre-operative baseline. (Scores for the International hip outcome tool range from 0-100 where higher values represent better outcomes)
Measured: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: NAHS
The secondary outcome is the differences in post-operative patient reported outcomes for the Non-arthritic Hip Score (NAHS) when compared to a pre-operative baseline. (Scores for the Non-arthritic Hip Score range from 0-80 where higher values represent better outcomes).
Measured: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: EQ5D
The secondary outcome is the differences in post-operative patient reported outcomes for the European Quality of Life Questionnaire (EQ-5D) when compared to a pre-operative baseline. (Scores for EQ-5D range from 1-5 in 5 categories where lower values represent better outcomes in each category).
Measured: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: EQ5D-VAS
The secondary outcome is the differences in post-operative patient reported outcomes for the European Quality of Life Questionnaire-Visual Analog Scale (EQ-5D-VAS) when compared to a pre-operative baseline. (Scores for EQ-5D-VAS range from 0-100 where higher values represent better outcomes).
Measured: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: VR-12
The secondary outcome is the differences in post-operative patient reported outcomes for the Veteran's RAND 12 Item Health Survey (VR-12) when compared to a pre-operative baseline. (Scores for VR-12 range from 0-100 where higher values represent better outcomes).
Measured: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: HOS-Usual Activities
The secondary outcome is the differences in post-operative patient reported outcomes for the Hip Outcome Score for usual activities (HOS-UA) when compared to a pre-operative baseline. (Scores for HOS range from 0-68 where higher values represent better outcomes).
Measured: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: HOS-Sport
The secondary outcome is the differences in post-operative patient reported outcomes for the Hip Outcome Score for sports (HOS-S) when compared to a pre-operative baseline. (Scores for HOS range from 0-30 where higher values represent better outcomes).
Measured: Change in outcomes 24 months post operatively compared to Pre-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Jan 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoro Acetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients that have consented to the study will be randomized into four groups with a 50% chance of being in either group. The two treatment groups are 1) conventional preoperative imaging (X-ray, CT, and MRI) only 2) those that have had a 3D printed model created in addition to conventional imaging. There will be 40 patients in each group. Randomization will be done with a computer random number generator. Both groups will undergo routine pre-operative imaging but one group will also have a 3D print made from the 3D CT reconstruction. Both patient groups will undergo hip arthroscopy for treatment of their FAI.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Wong, MD, Nova Scotia Health Authority
- Investigators
- Ivan Wong, Dr., Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505020
- Sponsor's protocol ID
- 3DPRINT
- Status last verified
- Feb 2025
- First submitted
- 30 Apr 2020
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Innovation of 3D Printing for Preoperative Planning in Hip Preservation Surgery
- ClinicalTrials.gov ID
- NCT04505020
- Acronym / sponsor ID
- 3DPRINT
- Conditions
- Femoro Acetabular Impingement
- Keywords
- Femoroacetabular Impingement, Cam lesion, 3D printing, Pre-operative planning
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Aug 2020 (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 is a randomized controlled trial (RCT) to evaluate the introduction of a 3D printed model into the pre and intra-operative planning for arthroscopic femoroacetabular impingement (FAI) surgery. The RCT will look to place patients into one of two treatment groups: 1) conventional preoperative imaging (X-ray, CT, and MRI) only and 2) those that have had a 3D printed model created in addition to the conventional imaging.
Detailed description
In this study, we investigate the use of 3D models during pre and intra-operative planning could improve the success of hip arthroscopy and reduce the incidence of revision cases. By adding an adjunct to the common suite of pre-operative imaging modalities (X-ray, MRI and CT), we can change the surgeon's understanding of each patient's individual morphology with a tactile physical model. This study will compare the success of hip arthroscopy in patients with or without 3D printed models (in addition to traditional pre-operative imaging).
This will be a single-center, blinded observer, randomized controlled trial of 80 patients performed at the Halifax Infirmary, Queen Elizabeth II Health Sciences Center in Halifax, Nova Scotia. Patients with cam-type FAI involved in the study will be approached by the surgeon, Dr. Ivan Wong, or a delegate regarding the study during a pre-operative visit. Following a detailed discussion of the risks/benefits/alternatives of this study, the patient will be provided with a copy of the informed consent to review, if they demonstrate an interest in the study. If the patient wishes to be enrolled in the study, the research team will obtain patient consent for the study according to the Division of Orthopaedic Surgery and Nova Scotia Health Authority (NSHA) institutional protocols.
In the pre-operative period, there will be no additional time requirements for the participant, except for the informed consent process for the study. Routine X-ray radiographs, as well as a pre-operative MRI and CT scan, will be obtained for all subjects undergoing FAI surgery. The participants will not be exposed to any additional radiation. Subjects will complete a structured clinical examination conducted by a sports medicine fellowship-trained orthopaedic consultant. The patient will also complete pre-operative questionnaires.
Patients that have consented to the study will be randomized into two groups with a 50% chance of being in either group. Randomization will be done with a computer random number generator. Both groups will undergo routine pre-operative imaging but one group will also have a 3D print made from the 3D CT reconstruction. All patient groups will undergo hip arthroscopy for the treatment of their FAI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients that have consented to the study will be randomized into four groups with a 50% chance of being in either group. The two treatment groups are 1) conventional preoperative imaging (X-ray, CT, and MRI) only 2) those that have had a 3D printed model created in addition to conventional imaging. There will be 40 patients in each group. Randomization will be done with a computer random number generator. Both groups will undergo routine pre-operative imaging but one group will also have a 3D print made from the 3D CT reconstruction. Both patient groups will undergo hip arthroscopy for treatment of their FAI.
| Arm | Type | Receives |
|---|---|---|
| 3D Print + Conventional imaging | Experimental | Other: 3D Print + Conventional imagingPatients in this group allocation will receive a 3D reconstruction of their hip in addition to conventional preoperative imaging (X-ray, CT, and MRI) only for the use of pre-operative and intra-operative planning for their hip arthroscopy (FAI) procedure. |
| Conventional Imaging | Other | Other: Conventional imagingPatients in this group allocation will receive conventional preoperative imaging (X-ray, CT, and MRI) only for the use of pre-operative and intra-operative planning for their hip arthroscopy (FAI) procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Radiological proven diagnosis of cam-type femoroacetabular impingement (FAI)
Key exclusion criteria (11 listed)
- Patients with advanced arthritis (Tonnis Grade III or Kellgren-Lawrence Grade III or IV or evidence of less than 2 mm of joint space, as determined by conventional radiographs.)
- Patients with 1cm2 (or greater) of cartilage delamination in the hip
- Patients with type III or IV heterotopic ossification
- Patients with avascular necrosis
- Patients who are unable to provide informed consent
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 Print + Conventional imagingThis group will have a 3D reconstruction of their hip printed using a 3D printer so that the PI can use it in their pre and intra-operative planning along with traditional imaging. | Other | 3D Print + Conventional imaging |
| Conventional imagingThis group will have CT, MRI and X-Ray imaging completed so that the PI can use it in their pre and intra-operative planning. | Other | Conventional Imaging |
Primary outcome
Measure of CAM resection
Time frame: Change in Pre-op measurements compared to 2 weeks post-operatively
Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.
Measure of CAM resection
Time frame: Change in Pre-op measurements compared to 6 months post-operatively
Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.
Measure of CAM resection
Time frame: Change in Pre-op measurements compared to 24 months post-operatively
Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.
7 secondary outcomes
Differences in post-operative patient reported outcomes: iHOT-33
Time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: NAHS
Time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: EQ5D
Time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: EQ5D-VAS
Time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: VR-12
Time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: HOS-Usual Activities
Time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
Differences in post-operative patient reported outcomes: HOS-Sport
Time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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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.
Ivan Wong, Dr. principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Print + Conventional imaging and Conventional imaging in people with Femoro Acetabular Impingement, run by Nova Scotia Health Authority at 1 site in Canada.
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 1 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 17 Feb 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Measure of CAM resection (time frame: Change in Pre-op measurements compared to 2 weeks post-operatively). The study lists 3 primary outcomes in all. 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 17 Feb 2025.