Hallux ValgusNCT05602844
Clinical Trial on Patient-Specific-Instrumentation Assisted Lapidus Fusion for Hallux Valgus
A study testing PSI Lapidus and Conventional Lapidus in people with Hallux Valgus and Bunion, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
RCT to compare the effectiveness of PSI assisted Lapidus surgery vs conventional Lapidus surgery in hallux valgus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus, Bunion, Patient Spe
- What is being tested?
- PSI Lapidus and Conventional Lapidus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2023to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic Hallux Valgus
- hallux valgus angle >20
- 1,2 Inter-metatarsal angle >9
Who cannot join
- Individuals with (1) disabilities (both physical and mental) which may impair the adherence of the rehabilitation, (2) revision HV surgery, (3) concomitantly undergone additional procedures on the same foot (e.g. claw toe surgery), (4) the use of medications that may influence bone turnover (e.g. chemotherapy, osteoporotic medications) in recent 3 months, (5) medical comorbidity leading to contraindication for surgery, (6) the inability to understand written Chinese/English, (7) who are mentally/physically unable to consent will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial Comparing the Outcome of the 3D-Printed Patient-Specific-Instrument Assisted Lapidus Fusion vs Conventional Lapidus Fusion for Surgical Correction of Hallux Valgus Deformity
RCT to compare the effectiveness of PSI assisted Lapidus surgery vs conventional Lapidus surgery in hallux valgus.
Read the detailed description
Hallux valgus (HV) affects up to 30% of the population. Lapidus surgery, a combination of 1st tarsal-metatarsal joint arthrodesis is one of the most common surgical options for HV. Despite its popularity, the current method alone is not without complications. This will be the world's first Lapidus arthrodesis surgery utilising patient-specific instruments (PSI) as an assistive tool. We hypothesise that PSI will enhance surgical precision, accelerate fusion rates, decrease non-unions, and reduce the need to use bone grafts.
Methods and analysis:
This is a single-blinded, parallel-group, randomised controlled trial comparing the outcome of the 3D-Printed PSI Assisted Lapidus Fusion (n=27) vs Conventional Lapidus Fusion (n=27) for HV deformity. Both groups will receive indentical post-operative rehabilitation of protected weight bearing and splinting. Outcomes measured will include foot function scores, radiological alignment and arthrodesis site assessment with X-ray and High-Resolution Peripheral Quantitative-Computed Tomography, and foot pressure analysis.
- Conditions
- Hallux Valgus, Bunion, Patient Spe
- Being tested
- PSI Lapidus, Conventional Lapidus
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSI LapidusProcedure or surgery
Design of PSI: DICOM files will be imported into the Model Intestinal Microflora in Computer Simulation (MIMICS 21.0) 3D image processing software (Materialize, Belgium) for 3D rendering. The segmented bone images will be used for design of the computer-aided modelling (CAM) surgical jigs. 3D printing of PSI jig. PSI-assisted Lapidus Surgery.
Conventional LapidusProcedure or surgery
exposure of the 1TMTJ via a 3-5cm medial longitudinal skin incision and capsulotomy. Freehand creation of the fusion surface with fluoroscopic assistance. Fixation of the Lapidus arthrodesis will be performed with two 3.5mm headless compression screws
| Study group | Role | What they receive |
|---|---|---|
| PSI Lapidus | Experimental | Design of PSI, 3D printing of PSI, PSI-assisted Lapidus Surgery. Receives: Procedure: PSI Lapidus |
| Conventional Lapidus | Active comparator | Lapidus Surgery: exposure of the 1TMTJ via a 3-5cm medial longitudinal skin incision and capsulotomy. Freehand creation of the fusion surface with fluoroscopic assistance. Fixation of the Lapidus arthrodesis will be performed with two 3.5mm headless compression screws. Receives: Procedure: Conventional Lapidus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Function
The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.
Measured: 0 week
Foot Function
The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.
Measured: 12 week
Foot Function
The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.
Measured: 26 week
Foot Function
The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.
Measured: 52 week
Time to Radiological Fusion
Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.
Measured: 2 week
Time to Radiological Fusion
Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.
Measured: 6 week
Time to Radiological Fusion
Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.
Measured: 12 week
Time to Radiological Fusion
Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.
Measured: 26 week
Time to Radiological Fusion
Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.
Measured: 52 week
High-resolution peripheral quantitive-Computed Tomography
HR pQCT allows us to visualize the bony micro-architecture at the Lapidus fusion site and is a more accurate assessment of bone growth compared to X-rays. A rectangular region of interest (ROI) will be established at the fusion surface, inner callus, and external callus area. The volumetric changes in bone mineral density (BMD) in each region will be analyzed.
Measured: 6 week
Secondary outcomes (9)
Deformity severity
Radiology can provide an objective outcome measurement, the 1,2 intermetatarsal angle (IMA) and hallux valgus angle (HVA) will be measured using dorsal-planar weight-bearing X-rays of the foot. The IMA is defined by drawing an angle from lines bisecting the 1st metatarsal and 2nd metatarsal shaft. A normal IMA is <9°, while the more severe the deformity, the larger the angle. The HVA is defined by drawing an angle from the bisecting lines of the 1st proximal phalanx shaft and the 1st metatarsal shaft. A normal HVA is <20° with a larger angle signifying a more severe deformity.
Measured: 0 week
Deformity severity
Radiology can provide an objective outcome measurement, the 1,2 intermetatarsal angle (IMA) and hallux valgus angle (HVA) will be measured using dorsal-planar weight-bearing X-rays of the foot. The IMA is defined by drawing an angle from lines bisecting the 1st metatarsal and 2nd metatarsal shaft. A normal IMA is <9°, while the more severe the deformity, the larger the angle. The HVA is defined by drawing an angle from the bisecting lines of the 1st proximal phalanx shaft and the 1st metatarsal shaft. A normal HVA is <20° with a larger angle signifying a more severe deformity.
Measured: 12 week
Deformity severity
Radiology can provide an objective outcome measurement, the 1,2 intermetatarsal angle (IMA) and hallux valgus angle (HVA) will be measured using dorsal-planar weight-bearing X-rays of the foot. The IMA is defined by drawing an angle from lines bisecting the 1st metatarsal and 2nd metatarsal shaft. A normal IMA is <9°, while the more severe the deformity, the larger the angle. The HVA is defined by drawing an angle from the bisecting lines of the 1st proximal phalanx shaft and the 1st metatarsal shaft. A normal HVA is <20° with a larger angle signifying a more severe deformity.
Measured: 26 week
Deformity severity
Radiology can provide an objective outcome measurement, the 1,2 intermetatarsal angle (IMA) and hallux valgus angle (HVA) will be measured using dorsal-planar weight-bearing X-rays of the foot. The IMA is defined by drawing an angle from lines bisecting the 1st metatarsal and 2nd metatarsal shaft. A normal IMA is <9°, while the more severe the deformity, the larger the angle. The HVA is defined by drawing an angle from the bisecting lines of the 1st proximal phalanx shaft and the 1st metatarsal shaft. A normal HVA is <20° with a larger angle signifying a more severe deformity.
Measured: 52 week
Delayed union rate
Delayed union was defined as greater than 50% lucency on either the AP and lateral radiographs or broken hardware at the fusion site 12 weeks post-surgery. If lucency, sclerosis, or lack of trabeculation extended more than one-half the length of the fusion site on either the dorsal-plantar or lateral radiograph, a radiographic delayed-union was declared
Measured: 12 week
Non-union rate
Non-union was defined as greater than 50% lucency on either the AP and lateral radiographs or broken hardware at the fusion site at 26 weeks post-surgery. If lucency, sclerosis, or lack of trabeculation extended more than one-half the length of the fusion site on either the dorsal-plantar or lateral radiograph, a radiographic non-union was declared
Measured: 26 week
Plantar pressure distribution
The Tekscan Matscan (Tekscan Inc., Boston MA) system will be used to measure the plantar pressure at different anatomical regions during the gait cycle
Measured: 0 week
Plantar pressure distribution
The Tekscan Matscan (Tekscan Inc., Boston MA) system will be used to measure the plantar pressure at different anatomical regions during the gait cycle
Measured: 26 week
Plantar pressure distribution
The Tekscan Matscan (Tekscan Inc., Boston MA) system will be used to measure the plantar pressure at different anatomical regions during the gait cycle
Measured: 52 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- single-blinded, parallel-group, randomised controlled trial will be conducted to compare the outcome of the 3D-Printed PSI Assisted Lapidus Fusion (n=27) vs Conventional Lapidus Fusion (n=27) for Surgical Correction of HV Deformity
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel KK Ling, Chinese University of Hong Kong
- Investigators
- Samuel Ling, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602844
- Sponsor's protocol ID
- HV PSI Lapidus
- Status last verified
- Sep 2023
- First submitted
- 28 Oct 2022
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not shared
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing the Outcome of the 3D-Printed Patient-Specific-Instrument Assisted Lapidus Fusion vs Conventional Lapidus Fusion for Surgical Correction of Hallux Valgus Deformity
- ClinicalTrials.gov ID
- NCT05602844
- Acronym / sponsor ID
- HV PSI Lapidus
- Conditions
- Hallux Valgus, Bunion, Patient Spe
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Nov 2022 (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.
RCT to compare the effectiveness of PSI assisted Lapidus surgery vs conventional Lapidus surgery in hallux valgus.
Detailed description
Hallux valgus (HV) affects up to 30% of the population. Lapidus surgery, a combination of 1st tarsal-metatarsal joint arthrodesis is one of the most common surgical options for HV. Despite its popularity, the current method alone is not without complications. This will be the world's first Lapidus arthrodesis surgery utilising patient-specific instruments (PSI) as an assistive tool. We hypothesise that PSI will enhance surgical precision, accelerate fusion rates, decrease non-unions, and reduce the need to use bone grafts.
Methods and analysis:
This is a single-blinded, parallel-group, randomised controlled trial comparing the outcome of the 3D-Printed PSI Assisted Lapidus Fusion (n=27) vs Conventional Lapidus Fusion (n=27) for HV deformity. Both groups will receive indentical post-operative rehabilitation of protected weight bearing and splinting. Outcomes measured will include foot function scores, radiological alignment and arthrodesis site assessment with X-ray and High-Resolution Peripheral Quantitative-Computed Tomography, and foot pressure analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- single-blinded, parallel-group, randomised controlled trial will be conducted to compare the outcome of the 3D-Printed PSI Assisted Lapidus Fusion (n=27) vs Conventional Lapidus Fusion (n=27) for Surgical Correction of HV Deformity
| Arm | Type | Receives |
|---|---|---|
| PSI Lapidus | Experimental | Procedure: PSI LapidusDesign of PSI, 3D printing of PSI, PSI-assisted Lapidus Surgery. |
| Conventional Lapidus | Active comparator | Procedure: Conventional LapidusLapidus Surgery: exposure of the 1TMTJ via a 3-5cm medial longitudinal skin incision and capsulotomy. Freehand creation of the fusion surface with fluoroscopic assistance. Fixation of the Lapidus arthrodesis will be performed with two 3.5mm headless compression screws. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic Hallux Valgus
- hallux valgus angle >20
- 1,2 Inter-metatarsal angle >9
Key exclusion criteria (1 listed)
- Individuals with (1) disabilities (both physical and mental) which may impair the adherence of the rehabilitation, (2) revision HV surgery, (3) concomitantly undergone additional procedures on the same foot (e.g. claw toe surgery), (4) the use of medications that may influence bone turnover (e.g. chemotherapy, osteoporotic medications) in recent 3 months, (5) medical comorbidity leading to contraindication for surgery, (6) the inability to understand written Chinese/English, (7) who are mentally/physically unable to consent will be excluded.
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 |
|---|---|---|
| PSI LapidusDesign of PSI: DICOM files will be imported into the Model Intestinal Microflora in Computer Simulation (MIMICS 21.0) 3D image processing software (Materialize, Belgium) for 3D rendering. The segmented bone images will be used for design of the computer-aided modelling (CAM) surgical jigs. 3D printing of PSI jig. PSI-assisted Lapidus Surgery. | Procedure or surgery | PSI Lapidus |
| Conventional Lapidusexposure of the 1TMTJ via a 3-5cm medial longitudinal skin incision and capsulotomy. Freehand creation of the fusion surface with fluoroscopic assistance. Fixation of the Lapidus arthrodesis will be performed with two 3.5mm headless compression screws | Procedure or surgery | Conventional Lapidus |
Primary outcome
Foot Function
Time frame: 0 week
The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.
Foot Function
Time frame: 12 week
The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.
Foot Function
Time frame: 26 week
The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.
Foot Function
Time frame: 52 week
The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.
Time to Radiological Fusion
Time frame: 2 week
Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.
Time to Radiological Fusion
Time frame: 6 week
Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.
Time to Radiological Fusion
Time frame: 12 week
Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.
Time to Radiological Fusion
Time frame: 26 week
Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.
Time to Radiological Fusion
Time frame: 52 week
Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.
High-resolution peripheral quantitive-Computed Tomography
Time frame: 6 week
HR pQCT allows us to visualize the bony micro-architecture at the Lapidus fusion site and is a more accurate assessment of bone growth compared to X-rays. A rectangular region of interest (ROI) will be established at the fusion surface, inner callus, and external callus area. The volumetric changes in bone mineral density (BMD) in each region will be analyzed.
9 secondary outcomes
Deformity severity
Time frame: 0 week
Deformity severity
Time frame: 12 week
Deformity severity
Time frame: 26 week
Deformity severity
Time frame: 52 week
Delayed union rate
Time frame: 12 week
Non-union rate
Time frame: 26 week
Plantar pressure distribution
Time frame: 0 week
Plantar pressure distribution
Time frame: 26 week
Plantar pressure distribution
Time frame: 52 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No. Not shared
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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.
Samuel Ling principal investigator
CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSI Lapidus and Conventional Lapidus in people with Hallux Valgus and Bunion, 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Sep 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?
Results are not available in the source record.
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?
Foot Function (time frame: 0 week). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2023.