Patient Specific Instrumentation (PSI) Referencing Osteotomy Technological Transfer - a Randomized Control Trial (RCT)
- Conditions
- Randomized Controlled TrialOsteotomy
- Interventions
- Procedure: 3D printed patient specific metal jigs (PSI jig)Procedure: HTO with navigation
- Registration Number
- NCT04000672
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
Medial open wedge high tibial osteotomy is a surgery performed to treat knee osteoarthritis in young patients.Recently with our department advance of technology, the investigators performed computed tomography for the patient's lower limb and 3D reconstruct the image. Based on the 3D image, the investigators planned our planned osteotomy cut on computer software Materialize 3 and the investigators then 3D printed a metal jig that has a slot to produce the osteotomy and also protected the neurovascular bundles. Therefore these metal jigs are specific to each patients. The investigators have performed a few cases of HTO under this extra metal jig protection and guidance and noted it has improved accuracy and safety clinically. However, whether it has scientific significance difference in accuracy is not known.
- Detailed Description
Medial open wedge high tibial osteotomy is a surgery performed to treat knee osteoarthritis in young patients. Currently the investigators perform high tibial osteotomy under the guidance of computer navigation to achieve the required alignment. During conventional high tibial osteotomy the bone cut is done by free hand cutting, there are risks of cutting into the posterior proximal tibia compartment and transect the neurovascular bundles which is a surgical disaster and may then lead to loss of limb. And the accuracy of free hand cutting is limited by experience of surgeons. In our conventional high tibial osteotomy transection of neurovascular bundles has never happened given our meticulous surgical technique but the investigators believe an extra protection is always beneficial to our patients. Recently with our department advance of technology, the investigators performed computed tomography for the patient's lower limb and 3D reconstruct the image. Based on the 3D image, the investigators planned our planned osteotomy cut on computer software Materialize 3 and the investigators then 3D printed a metal jig that has a slot to produce the osteotomy and also protected the neurovascular bundles. Therefore these metal jigs are specific to each patients. The investigators have performed a few cases of HTO under this extra metal jig protection and guidance and noted it has improved accuracy and safety clinically. However, whether it has scientific significance difference in accuracy is not known.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- symptomatic patient with medial compartment knee OA
- medial compartment OA was grade 3 or milder according to Kellgren-Lawrence classification
- lateral compartment OA
- symptomatic patellofemoral compartment OA,
- inflammatory arthritis,
- significant loss of knee joint range in flexion (less than 100°) or in extension (less than - 10°),
- ligamentous instability,
- obesity with a body mass index greater than 30,
- significant psychological disorder
- inability to communicate in Chinese or English language
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HTO with navigation + PSI jig HTO with navigation 3D printed patient specific metal jigs (PSI jig) are created based on the pre-operative CT image. After that, calibrated osteotome is used to achieve the desired correction with the use of navigation for overall lower limb alignment, which is the same as the "Active Comparator" group. HTO with navigation HTO with navigation High Tibial Osteotomy is offered to patients with symptomatic medial compartment knee osteoarthritis (OA) HTO with navigation + PSI jig 3D printed patient specific metal jigs (PSI jig) 3D printed patient specific metal jigs (PSI jig) are created based on the pre-operative CT image. After that, calibrated osteotome is used to achieve the desired correction with the use of navigation for overall lower limb alignment, which is the same as the "Active Comparator" group.
- Primary Outcome Measures
Name Time Method Pain Visual Analog Scale (VAS) score 2 year post-op The VAS is a psychometric response scale and a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The VAS pain ranges 0-10, with 10 representing the most pain.
Measurement of knee displacement 1 year after surgery Measure the displacement (in cm) between femoral head and tibial head on a secured computer using CT scan images and scanogram images
Knee Society knee score 2 year post-op Clinical and functional scores, on a 100-point scale; Knee Society score (KSS) has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. "Excellent" for score 80-100, "Good" for score 70-79, "Fair" for score 60-69, "Poor" for score below 60.
Knee Society function score 2 year post-op Clinical and functional scores, on a 100-point scale; Knee Society score (KSS) has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. "Excellent" for score 80-100, "Good" for score 70-79, "Fair" for score 60-69, "Poor" for score below 60.
Oxford Knee Score 2 year post-op Clinical and functional scores
Range of motion 2 year post-op Evaluated using a manual goniometer
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Prince of Wales Hospital & Alice Ho Miu Ling Nethersole Hospital
🇭🇰Sha Tin, Hong Kong