An interventional study of PSI Lapidus and Conventional Lapidus in Hallux Valgus, Bunion and Patient Spe, sponsored by Chinese University of Hong Kong. Active, not recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
RCT to compare the effectiveness of PSI assisted Lapidus surgery vs conventional Lapidus surgery in hallux valgus.
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.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 54 is close to the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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 for surgery, (6) the inability to understand written Chinese/English, (7) who are mentally/physically unable to consent will be excluded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Design of PSI, 3D printing of PSI, PSI-assisted Lapidus Surgery.
Procedure: PSI Lapidus
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.
Procedure: Conventional Lapidus
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.
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
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 frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 52 week
Plan to share: No — Not shared
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