OsteotomyProtectedHTONCT04000672
Patient Specific Instrumentation (PSI) Referencing Osteotomy Technological Transfer - a Randomized Control Trial (RCT)
A study testing 3D printed patient specific metal jigs (PSI jig) and HTO with navigation in people with Osteotomy and Randomized Controlled Trial, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteotomy, Randomized Controlled Trial
- What is being tested?
- 3D printed patient specific metal jigs (PSI jig) and HTO with navigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2019to 6 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic patient with medial compartment knee OA
- medial compartment OA was grade 3 or milder according to Kellgren-Lawrence classification
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Prince of Wales Hospital & Alice Ho Miu Ling Nethersole Hospital
Shatin
About this study
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
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.
Read the 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.
- Conditions
- Osteotomy, Randomized Controlled Trial
- Being tested
- 3D printed patient specific metal jigs (PSI jig), HTO with navigation
- Keywords
- Patient Specific Instrumentation, Randomized controlled trial, High Tibial Osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed patient specific metal jigs (PSI jig)Procedure or surgery
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 navigationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| HTO with navigation | Active comparator | High Tibial Osteotomy is offered to patients with symptomatic medial compartment knee osteoarthritis (OA) Receives: 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. Receives: Procedure: 3D printed patient specific metal jigs (PSI jig); Procedure: HTO with navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 year post-op
Oxford Knee Score
Clinical and functional scores
Measured: 1 week before surgery
Oxford Knee Score
Clinical and functional scores
Measured: 6 months post-op
Oxford Knee Score
Clinical and functional scores
Measured: 1 year post-op
Oxford Knee Score
Clinical and functional scores
Measured: 2 year post-op
Range of motion
Evaluated using a manual goniometer
Measured: 1 week before surgery
Range of motion
Evaluated using a manual goniometer
Measured: 1 week before discharge
Range of motion
Evaluated using a manual goniometer
Measured: 3 months post-op
Range of motion
Evaluated using a manual goniometer
Measured: 6 months post-op
Range of motion
Evaluated using a manual goniometer
Measured: 1 year post-op
Range of motion
Evaluated using a manual goniometer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Jul 2019
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteotomyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group: High tibial osteotomy with navigation Intervention group: High tibial osteotomy with navigation and PSI jig
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence CM Lau, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000672
- Sponsor's protocol ID
- 2019.050
- Acronym
- ProtectedHTO
- Status last verified
- Dec 2023
- First submitted
- 22 Jun 2019
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33550239
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04000672
- Acronym / sponsor ID
- ProtectedHTO / 2019.050
- Conditions
- Osteotomy, Randomized Controlled Trial
- Keywords
- Patient Specific Instrumentation, Randomized controlled trial, High Tibial Osteotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Control group: High tibial osteotomy with navigation Intervention group: High tibial osteotomy with navigation and PSI jig
| Arm | Type | Receives |
|---|---|---|
| HTO with navigation | Active comparator | Procedure: HTO with navigationHigh Tibial Osteotomy is offered to patients with symptomatic medial compartment knee osteoarthritis (OA) |
| HTO with navigation + PSI jig | Experimental | Procedure: 3D printed patient specific metal jigs (PSI jig), Procedure: HTO with navigation3D 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic patient with medial compartment knee OA
- medial compartment OA was grade 3 or milder according to Kellgren-Lawrence classification
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | HTO with navigation + PSI jig |
| HTO with navigationIn 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. | Procedure or surgery | HTO with navigation, HTO with navigation + PSI jig |
Primary outcome
Knee Society knee score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 week before surgery
Clinical and functional scores
Oxford Knee Score
Time frame: 6 months post-op
Clinical and functional scores
Oxford Knee Score
Time frame: 1 year post-op
Clinical and functional scores
Oxford Knee Score
Time frame: 2 year post-op
Clinical and functional scores
Range of motion
Time frame: 1 week before surgery
Evaluated using a manual goniometer
Range of motion
Time frame: 1 week before discharge
Evaluated using a manual goniometer
Range of motion
Time frame: 3 months post-op
Evaluated using a manual goniometer
Range of motion
Time frame: 6 months post-op
Evaluated using a manual goniometer
Range of motion
Time frame: 1 year post-op
Evaluated using a manual goniometer
Range of motion
Time frame: 2 year post-op
Evaluated using a manual goniometer
Pain Visual Analog Scale (VAS) score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 33550239Lau 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed patient specific metal jigs (PSI jig) and HTO with navigation in people with Osteotomy and Randomized Controlled Trial, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society knee score (time frame: 1 week before surgery). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04000672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.