Hallux Valgus and Bunion (Disorder)
Conditions
Keywords
hallux valgus and Bunion
Brief summary
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
Interventions
DEVICEFASTFORWARDTM Bunion
The participants will be assign to implantation of FASTFORWARDTM Bunion correction system surgery as a experimental group.
PROCEDUREConventional surgery
The participants will assign to conventional surgery as a control group, the procedure is a standard treatment for the 1st metatarsal hallux valgus.
Sponsors
China Medical University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intermetatarsal 1-2 angle postoperative | 6 month | Evaluating the angle among the 1st and the 2nd metatarsal assess by X-ray scan and CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment Foot Pressure | 6 month | Foot pressure assess by gait analysis |
| Pain using a visual analog scale | 6 month | Evaluating pain level by using visual analog scale |
| Intermetatarsal 1-2 angle | 6 month | Evaluating the angle among the first metatarsal and the first phalanx assess by X-ray scan |
Countries
Taiwan
Contacts
Primary ContactHsuan-Fang Ho
Backup ContactTuan-Ti Hsu
Outcome results
None listed