Clinical trial NCT03594292: FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients
Official title: Clinical Study of MedShape FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hallux Valgus and Bunion (Disorder)
Keywords: hallux valgus and Bunion
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Intermetatarsal 1-2 angle postoperative
timeFrame: 6 month
Secondary outcomes:
measure: Assessment Foot Pressure
timeFrame: 6 month
measure: Pain using a visual analog scale
timeFrame: 6 month
measure: Intermetatarsal 1-2 angle
timeFrame: 6 month
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: Beitun District
Study officials:
affiliation: China Medical University Hospital
name: Chien-Chung Kuo
role: PRINCIPAL_INVESTIGATOR
References: