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Clinical Trial on Patient-Specific-Instrumentation Assisted Lapidus Fusion for Hallux Valgus

Primary Purpose

Hallux Valgus, Bunion, Patient Spe

Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
PSI Lapidus
Conventional Lapidus
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Symptomatic Hallux Valgus hallux valgus angle >20 1,2 Inter-metatarsal angle >9 Exclusion Criteria: 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.

Sites / Locations

  • CUHK

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PSI Lapidus

Conventional Lapidus

Arm Description

Design of PSI, 3D printing of PSI, PSI-assisted Lapidus Surgery.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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
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
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
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
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

Full Information

First Posted
October 28, 2022
Last Updated
September 21, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05602844
Brief Title
Clinical Trial on Patient-Specific-Instrumentation Assisted Lapidus Fusion for Hallux Valgus
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Bunion, Patient Spe

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Outcome assessment will be performed by orthopaedic surgeons from the Foot and Ankle team; the patient and the outcome assessor will be blinded while the surgeon will not.
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PSI Lapidus
Arm Type
Experimental
Arm Description
Design of PSI, 3D printing of PSI, PSI-assisted Lapidus Surgery.
Arm Title
Conventional Lapidus
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PSI Lapidus
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Lapidus
Intervention Description
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
Primary Outcome Measure Information:
Title
Foot Function
Description
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 Frame
0 week
Title
Foot Function
Description
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 Frame
12 week
Title
Foot Function
Description
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 Frame
26 week
Title
Foot Function
Description
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 Frame
52 week
Title
Time to Radiological Fusion
Description
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 Frame
2 week
Title
Time to Radiological Fusion
Description
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 Frame
6 week
Title
Time to Radiological Fusion
Description
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 Frame
12 week
Title
Time to Radiological Fusion
Description
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 Frame
26 week
Title
Time to Radiological Fusion
Description
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 Frame
52 week
Title
High-resolution peripheral quantitive-Computed Tomography
Description
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.
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Deformity severity
Description
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.
Time Frame
0 week
Title
Deformity severity
Description
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.
Time Frame
12 week
Title
Deformity severity
Description
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.
Time Frame
26 week
Title
Deformity severity
Description
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.
Time Frame
52 week
Title
Delayed union rate
Description
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
Time Frame
12 week
Title
Non-union rate
Description
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
Time Frame
26 week
Title
Plantar pressure distribution
Description
The Tekscan Matscan (Tekscan Inc., Boston MA) system will be used to measure the plantar pressure at different anatomical regions during the gait cycle
Time Frame
0 week
Title
Plantar pressure distribution
Description
The Tekscan Matscan (Tekscan Inc., Boston MA) system will be used to measure the plantar pressure at different anatomical regions during the gait cycle
Time Frame
26 week
Title
Plantar pressure distribution
Description
The Tekscan Matscan (Tekscan Inc., Boston MA) system will be used to measure the plantar pressure at different anatomical regions during the gait cycle
Time Frame
52 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic Hallux Valgus hallux valgus angle >20 1,2 Inter-metatarsal angle >9 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Ling
Organizational Affiliation
CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
CUHK
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not shared

Learn more about this trial

Clinical Trial on Patient-Specific-Instrumentation Assisted Lapidus Fusion for Hallux Valgus

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