FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients

Study Overview
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Brief Summary
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The FASTFORWARDTM Bunion Correction system has been cleared by the United States Food and Drug Administration for sale. This study is to investigate the clinical outcome of MedShape FASTFORWARDTM Bunion Correction system in treating hallux valgus patients at CMUH. Criteria-There will be 12 subjects with a painful bunion and hallux valgus between 20 and 65 years of age and an adequate range of movement. Patients with rheumatoid arthritis, failed previous hallux valgus surgery and symptomatic and/or radiological arthritis of the MTP joint will be excluded. Protocol-The PI and SC explain the detail and purpose of the project to the patient to the language to the patient is comfortable with. The explanation has to be at least 1 hour. Be sure the patients understand the full detail before the surgery. Computer tomography scan, gait analysis and blood biochemical analysis will be taken in 1-2 weeks after patient is enrolled in the subject. Before surgery, the titration bone tether plate designed to match patent's second metatarsal contour will be manufactured using 3D printing technology. Printed titanium plate and PEEK screws used to secure tethering suture tape in the first metatarsal will be sterilized prior implantation. The surgery time, recovery period and effectiveness after implantation will be recorded. To observing the recovery situation, patients will back to out-patient clinic at 1st, 2nd, 3rd, 4th, 6th, 12th, 24th weeks. During these period, physical examination, wound dressing, VAS, X-ray scan will be arranged. The detail arrangements below: 1.1st week: physical examination, wound dressing, VAS 2.2nd week: physical examination, wound dressing, VAS 3.3rd week: physical examination, wound dressing, VAS, X-ray scan, remove stiches 4.4th week: physical examination, VAS 5.6th week: physical examination, VAS, X-ray scan 6.12th week: physical examination, VAS, X-ray scan 7.24th week: physical examination, VAS, X-ray scan, CT scan, gait analysis

Official Title
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Clinical Study of MedShape FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients

Conditions
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Hallux Valgus and Bunion (Disorder)

Intervention / Treatment
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* Device: FASTFORWARDTM Bunion
* Procedure: Conventional surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a painful bunion and hallux valgus between 20 and 65 years of age and an adequate range of movement Exclusion Criteria: Patients with rheumatoid arthritis, failed previous hallux valgus surgery and symptomatic and/or radio-logical arthritis of the MTP joint

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FASTFORWARDTM Bunion<br>The participants are treated with FASTFORWARDTM Bunion Correction system. The FASTFORWARDTM Bunion Correction system employed 3D printed titanium bone tether plate at second metatarsal. Due to the merit of 3D printing technology, the plate is designed to broadly distribute forces across bone to secure mechanical integrity of the bone. The FASTFORWARDTM Bunion Correction system has been cleared by the United States Food and Drug Administration. | Device: FASTFORWARDTM Bunion<br>* The participants will be assign to implantation of FASTFORWARDTM Bunion correction system surgery as a experimental group.<br>|
| Active Comparator: Conventional Surgery<br>The participants are treated with fusion surgery. This procedures is a standard treatment for 1st metatarsal hallux valgus by cutting, realigning and fusing the 1st metatarsal or fusing the metatarsal-cuneiform joint. | Procedure: Conventional surgery<br>* The participants will assign to conventional surgery as a control group, the procedure is a standard treatment for the 1st metatarsal hallux valgus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intermetatarsal 1-2 angle postoperative | Evaluating the angle among the 1st and the 2nd metatarsal assess by X-ray scan and CT scan | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment Foot Pressure | Foot pressure assess by gait analysis | 6 month | 
| Pain using a visual analog scale | Evaluating pain level by using visual analog scale | 6 month | 
| Intermetatarsal 1-2 angle | Evaluating the angle among the first metatarsal and the first phalanx assess by X-ray scan | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hallux valgus and Bunion