Hallux Valgus and Bunion (Disorder)NCT03594292
FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients
A study testing FASTFORWARDTM Bunion and Conventional surgery in people with Hallux Valgus and Bunion (Disorder), run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hallux Valgus and Bunion (Disorder)
- What is being tested?
- FASTFORWARDTM Bunion and Conventional surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 May 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a painful bunion and hallux valgus between 20 and 65 years of age and an adequate range of movement
Who cannot join
- Patients with rheumatoid arthritis, failed previous hallux valgus surgery and symptomatic and/or radio-logical arthritis of the MTP joint
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, Beitun District, 404
Hsuan-Fang Ho, 886-4-2296-7979 ext. 3714, hlucy0630@gmail.com
Tuan-Ti Hsu, 886-4-2296-7979 ext. 3703, nakohsu@gmail.com
About this study
Official title: 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.
Read more
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
- Conditions
- Hallux Valgus and Bunion (Disorder)
- Being tested
- FASTFORWARDTM Bunion, Conventional surgery
- Keywords
- hallux valgus and Bunion
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FASTFORWARDTM BunionDevice
The participants will be assign to implantation of FASTFORWARDTM Bunion correction system surgery as a experimental group.
Conventional surgeryProcedure or surgery
The participants will assign to conventional surgery as a control group, the procedure is a standard treatment for the 1st metatarsal hallux valgus.
| Study group | Role | What they receive |
|---|---|---|
| FASTFORWARDTM Bunion | Experimental | 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. Receives: Device: FASTFORWARDTM Bunion |
| Conventional Surgery | Active comparator | 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. Receives: Procedure: Conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermetatarsal 1-2 angle postoperative
Evaluating the angle among the 1st and the 2nd metatarsal assess by X-ray scan and CT scan
Measured: 6 month
Secondary outcomes (3)
Assessment Foot Pressure
Foot pressure assess by gait analysis
Measured: 6 month
Pain using a visual analog scale
Evaluating pain level by using visual analog scale
Measured: 6 month
Intermetatarsal 1-2 angle
Evaluating the angle among the first metatarsal and the first phalanx assess by X-ray scan
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start31 May 2018
- Primary completionFeb 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus and Bunion (Disorder)Studies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Chung Kuo, China Medical University Hospital
- Investigators
- Chien-Chung Kuo, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594292
- Sponsor's protocol ID
- CMUH105-REC2-075
- Status last verified
- Jan 2018
- First submitted
- 24 Jun 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of MedShape FASTFORWARDTM Bunion Correction System in Treating Hallux Valgus Patients
- ClinicalTrials.gov ID
- NCT03594292
- Acronym / sponsor ID
- CMUH105-REC2-075
- Conditions
- Hallux Valgus and Bunion (Disorder)
- Keywords
- hallux valgus and Bunion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FASTFORWARDTM Bunion | Experimental | Device: FASTFORWARDTM BunionThe 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 comparator | Procedure: Conventional surgeryThe 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a painful bunion and hallux valgus between 20 and 65 years of age and an adequate range of movement
Key exclusion criteria (1 listed)
- Patients with rheumatoid arthritis, failed previous hallux valgus surgery and symptomatic and/or radio-logical arthritis of the MTP joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FASTFORWARDTM BunionThe participants will be assign to implantation of FASTFORWARDTM Bunion correction system surgery as a experimental group. | Device | FASTFORWARDTM Bunion |
| Conventional surgeryThe participants will assign to conventional surgery as a control group, the procedure is a standard treatment for the 1st metatarsal hallux valgus. | Procedure or surgery | Conventional Surgery |
Primary outcome
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
3 secondary outcomes
Assessment Foot Pressure
Time frame: 6 month
Pain using a visual analog scale
Time frame: 6 month
Intermetatarsal 1-2 angle
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Hallux Valgus and Bunion (Disorder)
Active, not recruiting
LSTR in Chevron Osteotomy
Bunion
Not yet recruiting
Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities
Hallux Valgus and Bunion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Chung Kuo principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FASTFORWARDTM Bunion and Conventional surgery in people with Hallux Valgus and Bunion (Disorder), run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsuan-Fang Ho (886-4-2296-7979 ext. 3714, hlucy0630@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intermetatarsal 1-2 angle postoperative (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.