FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients

China Medical University

Status: Unknown

Conditions: Hallux Valgus and Bunion (Disorder)

Treatments: Device: FASTFORWARDTM Bunion; Procedure: Conventional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03594292

CMUH105-REC2-075

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

FASTFORWARDTM Bunion

Experimental group

Description:

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.

Treatment:

Device: FASTFORWARDTM Bunion

Conventional Surgery

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional surgery