FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients

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

Study Overview

• Status: Unknown
• Conditions: Hallux Valgus and Bunion (Disorder)
• Intervention / Treatment: Device: FASTFORWARDTM Bunion; Procedure: Conventional surgery

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Beitun District
    • Taichung, Beitun District, Taiwan, 404
      • Recruiting
      • China Medical University Hospital
      • Contact: Hsuan-Fang Ho; Phone Number: 3714 886-4-2296-7979; Email: hlucy0630@gmail.com
      • Contact: Tuan-Ti Hsu; Phone Number: 3703 886-4-2296-7979; Email: nakohsu@gmail.com
      • Principal Investigator: Chien-Chung Kuo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FASTFORWARDTM Bunion; 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.	Device: FASTFORWARDTM Bunion; The participants will be assign to implantation of FASTFORWARDTM Bunion correction system surgery as a experimental group.
Active Comparator: Conventional Surgery; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment Foot Pressure	Foot pressure assess by gait analysis	6 month
Pain using a visual analog scale	Evaluating pain level by using visual analog scale	6 month
Intermetatarsal 1-2 angle	Evaluating the angle among the first metatarsal and the first phalanx assess by X-ray scan	6 month

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Chien-Chung Kuo, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 24, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: hallux valgus and Bunion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion
• Other Study ID Numbers: CMUH105-REC2-075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes