FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients
Clinical Study of MedShape FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients
1 other identifier
interventional
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2018
CompletedFirst Submitted
Initial submission to the registry
June 24, 2018
CompletedFirst Posted
Study publicly available on registry
July 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 20, 2018
January 1, 2018
8 months
June 24, 2018
July 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Assessment Foot Pressure
6 month
Pain using a visual analog scale
6 month
Intermetatarsal 1-2 angle
6 month
Study Arms (2)
FASTFORWARDTM Bunion
EXPERIMENTALThe 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.
Conventional Surgery
ACTIVE COMPARATORThe 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.
Interventions
The participants will be assign to implantation of FASTFORWARDTM Bunion correction system surgery as a experimental group.
The participants will assign to conventional surgery as a control group, the procedure is a standard treatment for the 1st metatarsal hallux valgus.
Eligibility Criteria
You may qualify if:
- Patients with a painful bunion and hallux valgus between 20 and 65 years of age and an adequate range of movement
You may not qualify if:
- Patients with rheumatoid arthritis, failed previous hallux valgus surgery and symptomatic and/or radio-logical arthritis of the MTP joint
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, Beitun District, 404, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chien-Chung Kuo
China Medical University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician, Department of Orthopedics
Study Record Dates
First Submitted
June 24, 2018
First Posted
July 20, 2018
Study Start
May 31, 2018
Primary Completion
February 1, 2019
Study Completion
December 1, 2019
Last Updated
July 20, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share