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

NCT ID: NCT04000672

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2023-12-06

Brief Summary

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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

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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.

Conditions

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Osteotomy Randomized Controlled Trial

Keywords

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Patient Specific Instrumentation Randomized controlled trial High Tibial Osteotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control group: High tibial osteotomy with navigation Intervention group: High tibial osteotomy with navigation and PSI jig
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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HTO with navigation

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

Group Type ACTIVE_COMPARATOR

HTO with navigation

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

3D printed patient specific metal jigs (PSI jig)

Intervention Type PROCEDURE

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.

HTO with navigation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Lawrence CM Lau

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prince of Wales Hospital & Alice Ho Miu Ling Nethersole Hospital

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Lau LCM, Chui ECS, Fan JCH, Man GCW, Hung YW, Ho KKW, Chung KY, Wan SYC, Chau JWW, Yung PSH, Bhandari M. Patient-specific instrumentation (PSI) Referencing High Tibial Osteotomy Technological Transfer and Education: protocol for a double-blind, randomised controlled trial (PROTECTED HTO Trial). BMJ Open. 2021 Feb 5;11(2):e041129. doi: 10.1136/bmjopen-2020-041129.

Reference Type DERIVED
PMID: 33550239 (View on PubMed)

Other Identifiers

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2019.050

Identifier Type: -

Identifier Source: org_study_id