FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients
NCT ID: NCT03594292
Last Updated: 2018-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2018-05-31
2019-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FASTFORWARDTM Bunion
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.
FASTFORWARDTM Bunion
The participants will be assign to implantation of FASTFORWARDTM Bunion correction system surgery as a experimental group.
Conventional Surgery
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.
Conventional surgery
The participants will assign to conventional surgery as a control group, the procedure is a standard treatment for the 1st metatarsal hallux valgus.
Interventions
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FASTFORWARDTM Bunion
The participants will be assign to implantation of FASTFORWARDTM Bunion correction system surgery as a experimental group.
Conventional surgery
The participants will assign to conventional surgery as a control group, the procedure is a standard treatment for the 1st metatarsal hallux valgus.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
65 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Chien-Chung Kuo
Attending Physician, Department of Orthopedics
Principal Investigators
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Chien-Chung Kuo
Role: PRINCIPAL_INVESTIGATOR
China Medical University Hospital
Locations
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China Medical University Hospital
Taichung, Beitun District, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMUH105-REC2-075
Identifier Type: -
Identifier Source: org_study_id
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