Clinical trial NCT04505020: The Innovation of 3D Printing for Preoperative Planning in Hip Preservation Surgery
Official title: The Innovation of 3D Printing for Preoperative Planning in Hip Preservation Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Femoro Acetabular Impingement
Keywords: Femoroacetabular Impingement
Cam lesion
3D printing
Pre-operative planning
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Radiological proven diagnosis of cam-type femoroacetabular impingement (FAI)

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Measure of CAM resection
timeFrame: Change in Pre-op measurements compared to 2 weeks post-operatively
measure: Measure of CAM resection
timeFrame: Change in Pre-op measurements compared to 6 months post-operatively
measure: Measure of CAM resection
timeFrame: Change in Pre-op measurements compared to 24 months post-operatively
Secondary outcomes:
measure: Differences in post-operative patient reported outcomes: iHOT-33
timeFrame: Change in outcomes 24 months post operatively compared to Pre-operatively
measure: Differences in post-operative patient reported outcomes: NAHS
timeFrame: Change in outcomes 24 months post operatively compared to Pre-operatively
measure: Differences in post-operative patient reported outcomes: EQ5D
timeFrame: Change in outcomes 24 months post operatively compared to Pre-operatively
measure: Differences in post-operative patient reported outcomes: EQ5D-VAS
timeFrame: Change in outcomes 24 months post operatively compared to Pre-operatively
measure: Differences in post-operative patient reported outcomes: VR-12
timeFrame: Change in outcomes 24 months post operatively compared to Pre-operatively
measure: Differences in post-operative patient reported outcomes: HOS-Usual Activities
timeFrame: Change in outcomes 24 months post operatively compared to Pre-operatively
measure: Differences in post-operative patient reported outcomes: HOS-Sport
timeFrame: Change in outcomes 24 months post operatively compared to Pre-operatively
Other outcomes:
measure: The number of times conventional imaging and 3D prints are referenced intra-operatively.
timeFrame: During surgery only
Locations:
city: Halifax
country: Canada
facility: 5955 Veterans' Memorial Lane Room 2106, VMB
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Ivan Wong, Dr.
role: PRINCIPAL_INVESTIGATOR
References: