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Trial record 25 of 3030 for:    China Medicine University Hospital

FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients

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ClinicalTrials.gov Identifier: NCT03594292
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Chien-Chung Kuo, China Medical University Hospital

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


Condition or disease Intervention/treatment Phase
Hallux Valgus and Bunion (Disorder) Device: FASTFORWARDTM Bunion Procedure: Conventional surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of MedShape FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Intermetatarsal 1-2 angle postoperative [ Time Frame: 6 month ]
    Evaluating the angle among the 1st and the 2nd metatarsal assess by X-ray scan and CT scan


Secondary Outcome Measures :
  1. Assessment Foot Pressure [ Time Frame: 6 month ]
    Foot pressure assess by gait analysis

  2. Pain using a visual analog scale [ Time Frame: 6 month ]
    Evaluating pain level by using visual analog scale

  3. Intermetatarsal 1-2 angle [ Time Frame: 6 month ]
    Evaluating the angle among the first metatarsal and the first phalanx assess by X-ray scan



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594292


Contacts
Contact: Hsuan-Fang Ho 886-4-2296-7979 ext 3714 hlucy0630@gmail.com
Contact: Tuan-Ti Hsu 886-4-2296-7979 ext 3703 nakohsu@gmail.com

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Beitun District, Taiwan, 404
Contact: Hsuan-Fang Ho    886-4-2296-7979 ext 3714    hlucy0630@gmail.com   
Contact: Tuan-Ti Hsu    886-4-2296-7979 ext 3703    nakohsu@gmail.com   
Principal Investigator: Chien-Chung Kuo         
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Chien-Chung Kuo China Medical University Hospital

Responsible Party: Chien-Chung Kuo, Attending Physician, Department of Orthopedics, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03594292     History of Changes
Other Study ID Numbers: CMUH105-REC2-075
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Chien-Chung Kuo, China Medical University Hospital:
hallux valgus and Bunion

Additional relevant MeSH terms:
Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired