Clinical trial NCT05602844: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hallux Valgus
Bunion
Patient Spe
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Foot Function
timeFrame: 0 week
measure: Foot Function
timeFrame: 12 week
measure: Foot Function
timeFrame: 26 week
measure: Foot Function
timeFrame: 52 week
measure: Time to Radiological Fusion
timeFrame: 2 week
measure: Time to Radiological Fusion
timeFrame: 6 week
measure: Time to Radiological Fusion
timeFrame: 12 week
measure: Time to Radiological Fusion
timeFrame: 26 week
measure: Time to Radiological Fusion
timeFrame: 52 week
measure: High-resolution peripheral quantitive-Computed Tomography
timeFrame: 6 week
Secondary outcomes:
measure: Deformity severity
timeFrame: 0 week
measure: Deformity severity
timeFrame: 12 week
measure: Deformity severity
timeFrame: 26 week
measure: Deformity severity
timeFrame: 52 week
measure: Delayed union rate
timeFrame: 12 week
measure: Non-union rate
timeFrame: 26 week
measure: Plantar pressure distribution
timeFrame: 0 week
measure: Plantar pressure distribution
timeFrame: 26 week
measure: Plantar pressure distribution
timeFrame: 52 week
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: CUHK
Study officials:
affiliation: CUHK
name: Samuel Ling
role: PRINCIPAL_INVESTIGATOR
References: