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

NCT04000672 | Completed

• 1 other identifier: 2019.050
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteotomy; Randomized Controlled Trial

Keywords

Patient Specific Instrumentation; Randomized controlled trial; High Tibial Osteotomy

Outcome Measures

Primary Outcomes (26)

• Knee Society knee score

  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.

  1 week before surgery

• Knee Society knee score

  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.

  6 months post-op

• Knee Society knee score

  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.

  1 year post-op

• Knee Society knee score

  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.

  2 year post-op

• Knee Society function score

  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.

  1 week before surgery

• Knee Society function score

  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.

  6 months post-op

• Knee Society function score

  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.

  1 year post-op

• Knee Society function score

  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.

  2 year post-op

• Oxford Knee Score

  Clinical and functional scores

  1 week before surgery

• Oxford Knee Score

  Clinical and functional scores

  6 months post-op

• Oxford Knee Score

  Clinical and functional scores

  1 year post-op

• Oxford Knee Score

  Clinical and functional scores

  2 year post-op

• Range of motion

  Evaluated using a manual goniometer

  1 week before surgery

• Range of motion

  Evaluated using a manual goniometer

  1 week before discharge

• Range of motion

  Evaluated using a manual goniometer

  3 months post-op

• Range of motion

  Evaluated using a manual goniometer

  6 months post-op

• Range of motion

  Evaluated using a manual goniometer

  1 year post-op

• Range of motion

  Evaluated using a manual goniometer

  2 year post-op

• Pain Visual Analog Scale (VAS) score

  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.

  1 week before surgery

• Pain Visual Analog Scale (VAS) score

  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.

  1 week before discharge

• Pain Visual Analog Scale (VAS) score

  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.

  3 months post-op

• Pain Visual Analog Scale (VAS) score

  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.

  6 months post-op

• Pain Visual Analog Scale (VAS) score

  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.

  1 year post-op

• Pain Visual Analog Scale (VAS) score

  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.

  2 year post-op

• Measurement of knee displacement

  Measure the displacement (in cm) between femoral head and tibial head on a secured computer using CT scan images and scanogram images

  1 week before surgery

• Measurement of knee displacement

  Measure the displacement (in cm) between femoral head and tibial head on a secured computer using CT scan images and scanogram images

  1 year after surgery

Study Arms (2)

HTO with navigation

ACTIVE COMPARATOR

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

Procedure: HTO with navigation

HTO with navigation + PSI jig

EXPERIMENTAL

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); Procedure: HTO with navigation

Interventions

3D printed patient specific metal jigs (PSI jig) 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 + PSI jig

HTO with navigation 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; HTO with navigation + PSI jig

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital & Alice Ho Miu Ling Nethersole Hospital

Shatin, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 33550239 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

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

Study Record Dates

• First Submitted: June 22, 2019
• First Posted: June 27, 2019
• Study Start: July 1, 2019
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after study completes
• Access Criteria: Data and resources will be shared with other eligible investigators through academically established means. The protocol and datasets used and/or analysed in this study will be available from the corresponding author on reasonable request.

Locations

HK (1)