FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients

Hallux Valgus and Bunion (Disorder) Clinical Trial

Official title:

Clinical Study of MedShape FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03594292
• Other study ID #: CMUH105-REC2-075
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: China Medical University Hospital
• Contact: Hsuan-Fang Ho
• Phone: 886-4-2296-7979
• Email: hlucy0630[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus
• Hallux Valgus and Bunion (Disorder)

Intervention

Device:
• FASTFORWARDTM Bunion
The participants will be assign to implantation of FASTFORWARDTM Bunion correction system surgery as a experimental group.

Procedure:
• 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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung	Beitun District

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intermetatarsal 1-2 angle postoperative	Evaluating the angle among the 1st and the 2nd metatarsal assess by X-ray scan and CT scan	6 month
Secondary	Assessment Foot Pressure	Foot pressure assess by gait analysis	6 month
Secondary	Pain using a visual analog scale	Evaluating pain level by using visual analog scale	6 month
Secondary	Intermetatarsal 1-2 angle	Evaluating the angle among the first metatarsal and the first phalanx assess by X-ray scan	6 month