Hallux Valgus and Bunion (Disorder) Clinical Trial
Official title:
Clinical Study of MedShape FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial
|
N/A | |
| Completed |
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