ProtectedHTO: Patient Specific Instrumentation (PSI) Referencing Osteotomy Technological Transfer - a Randomized Control Trial (RCT)

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT04000672

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteotomy Randomized Controlled Trial	Procedure: 3D printed patient specific metal jigs (PSI jig) Procedure: HTO with navigation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Control group: High tibial osteotomy with navigation Intervention group: High tibial osteotomy with navigation and PSI jigControl group: High tibial osteotomy with navigation Intervention group: High tibial osteotomy with navigation and PSI jig

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Randomization will be accomplished by computer-generated randomization sequence using serially numbered opaque, sealed envelopes with patients assigned either to intervention or control groups. All investigators, research staff, patients except the surgeon performing the HTO will be blinded to the group assignment of the subjects. Nor they will be aware of the regimen prescribed during the study and evaluation periods. A randomization code will be allocated to each included subjects to maintain blindness. Randomization code will be broken only after the database had been locked. Patient rehabilitation, post-operative assessment and Data analysis are conducted by personnel blinded to the patients' randomization assignment.

Primary Purpose:

Treatment

Official Title:

Patient Specific Instrumentation (PSI) Referencing Osteotomy Technological Transfer and Education - a PSI High Tibial Osteotomy, Double-blinded, Randomized Controlled Trial - the PROTECTED HTO (High Tibial Osteotomy) Trial

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HTO with navigation High Tibial Osteotomy is offered to patients with symptomatic medial compartment knee osteoarthritis (OA)	Procedure: HTO with navigation In brief, an incision is made in the midway between posteromedial border of the tibia and medial aspect of the tibial tuberosity. Sartorius fascia is cut and retracted medially to expose the medial collateral ligament (MCL). Two to three K-wires are placed 4 cm below the medial joint line toward the safe zone (an area between the tip of the fibular head and the remnant of fibular head epiphysis line) of the lateral cortex under fluoroscopy and osteotomy is done below and parallel to the k-wires using an oscillating saw leaving the lateral 10 mm intact.
Experimental: HTO with navigation + 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.	Procedure: 3D printed patient specific metal jigs (PSI jig) PSI jig is created based on the pre-operative CT image. Standard medial open wedge osteotomy described previously is performed. Incision is made in the midway between posteromedial border of the tibia and medial aspect of the tibial tuberosity. Sartorius fascia is cut and retracted medially to expose the medial collateral ligament (MCL). Then the PSI jig is positioned onto the tibia. Due to the jig patient specific design (individually based on each patient's CT image), it can fit closely to the proximal tibia. The slot opening on the PSI jig corresponds to 4 cm below the medial joint line and the slot design allow the sawblade cut direction toward the safe zone of the lateral cortex under fluoroscopy. The PSI Jig is removed after the bone cut completed and would not retain in patient's body. Procedure: HTO with navigation In brief, an incision is made in the midway between posteromedial border of the tibia and medial aspect of the tibial tuberosity. Sartorius fascia is cut and retracted medially to expose the medial collateral ligament (MCL). Two to three K-wires are placed 4 cm below the medial joint line toward the safe zone (an area between the tip of the fibular head and the remnant of fibular head epiphysis line) of the lateral cortex under fluoroscopy and osteotomy is done below and parallel to the k-wires using an oscillating saw leaving the lateral 10 mm intact.

Arm

Intervention/Treatment

Active Comparator: HTO with navigation

High Tibial Osteotomy is offered to patients with symptomatic medial compartment knee osteoarthritis (OA)

Procedure: HTO with navigation

In brief, an incision is made in the midway between posteromedial border of the tibia and medial aspect of the tibial tuberosity. Sartorius fascia is cut and retracted medially to expose the medial collateral ligament (MCL). Two to three K-wires are placed 4 cm below the medial joint line toward the safe zone (an area between the tip of the fibular head and the remnant of fibular head epiphysis line) of the lateral cortex under fluoroscopy and osteotomy is done below and parallel to the k-wires using an oscillating saw leaving the lateral 10 mm intact.

Experimental: HTO with navigation + 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.

Procedure: 3D printed patient specific metal jigs (PSI jig)

PSI jig is created based on the pre-operative CT image. Standard medial open wedge osteotomy described previously is performed. Incision is made in the midway between posteromedial border of the tibia and medial aspect of the tibial tuberosity. Sartorius fascia is cut and retracted medially to expose the medial collateral ligament (MCL). Then the PSI jig is positioned onto the tibia. Due to the jig patient specific design (individually based on each patient's CT image), it can fit closely to the proximal tibia. The slot opening on the PSI jig corresponds to 4 cm below the medial joint line and the slot design allow the sawblade cut direction toward the safe zone of the lateral cortex under fluoroscopy. The PSI Jig is removed after the bone cut completed and would not retain in patient's body.

Procedure: HTO with navigation

Outcome Measures

Primary Outcome Measures

Knee Society knee score [1 week before surgery]
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 knee score [6 months 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 knee score [1 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 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 [1 week before surgery]
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 [6 months 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 [1 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 [1 week before surgery]
Clinical and functional scores
Oxford Knee Score [6 months post-op]
Clinical and functional scores
Oxford Knee Score [1 year post-op]
Clinical and functional scores
Oxford Knee Score [2 year post-op]
Clinical and functional scores
Range of motion [1 week before surgery]
Evaluated using a manual goniometer
Range of motion [1 week before discharge]
Evaluated using a manual goniometer
Range of motion [3 months post-op]
Evaluated using a manual goniometer
Range of motion [6 months post-op]
Evaluated using a manual goniometer
Range of motion [1 year post-op]
Evaluated using a manual goniometer
Range of motion [2 year post-op]
Evaluated using a manual goniometer
Pain Visual Analog Scale (VAS) score [1 week before surgery]
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.
Pain Visual Analog Scale (VAS) score [1 week before discharge]
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.
Pain Visual Analog Scale (VAS) score [3 months 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.
Pain Visual Analog Scale (VAS) score [6 months 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.
Pain Visual Analog Scale (VAS) score [1 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.
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 week before surgery]
Measure the displacement (in cm) between femoral head and tibial head on a secured computer using CT scan images and scanogram images
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

symptomatic patient with medial compartment knee OA
medial compartment OA was grade 3 or milder according to Kellgren-Lawrence classification

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital & Alice Ho Miu Ling Nethersole Hospital	Sha Tin		Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lawrence CM Lau, Principle Investigator, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT04000672

Other Study ID Numbers:

2019.050

First Posted:

Jun 27, 2019

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lawrence CM Lau, Principle Investigator, Chinese University of Hong Kong

Patient Specific Instrumentation

Randomized controlled trial

High Tibial Osteotomy

Study Results

No Results Posted as of Mar 15, 2022