First Metatarsophalangeal Joint ArthritisNCT03290586
Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis
An observational study of First Metatarsophalangeal Joint Arthritis, run by JEM Research Institute at 1 site in United States.
Trial summary
This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \and hardware complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First Metatarsophalangeal Joint Arthritis
- What is being tested?
- Flower Cube
- Type of treatment
- Medical device
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2017to 3 Apr 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from the surgeons' private practices. These patients have already met the criteria for surgical intervention and have agreed to undergo the operative procedure and postoperative management.
Who may be able to join
- Painful Hallux Limitus or Rigidus
- Painful Geriatric Hallux Valgus
- Failed prior 1st MTP joint arthroplasty (hemi-total)
- Arthritis of any etiology other than degenerative causes
Who cannot join
- Age less than 18 years
- Pregnant Females
- Active or prior infection at the target joint
- Immunocompromised patients
- Patients unwilling to sign informed consent
- Patient's unwilling to participate the in study protocol
- Subject with known sensitivity to titanium implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis; the Evaluation of a Novel, Single Use Sterile, Disposable Delivery System
This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \and hardware complications.
- Being tested
- Flower Cube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flower CubeDevice
single use, sterile disposable fixation construct
What is being measured
The primary outcome is the main question the study is designed to answer.
Union Rates
Confirm union rates comparable to existing outcomes complications with our proposed construct.
Measured: 12 months
Hardware Failures
Evaluate hardware failures with our proposed construct.
Measured: 12 months
Complications
Evaluate complications with the procedure
Measured: 12 months
Secondary outcomes (1)
Cost Data
Review cost data using the Flower Orthopedics single use, sterile disposable fixation construct performed in an outpatient surgical setting compared to in patient hospital setting.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start16 Feb 2017
- Primary completion3 Apr 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Metatarsophalangeal Joint ArthritisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- JEM Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Flower Orthopedics
- Responsible party
- Principal investigator, John Levin, JEM Research Institute
- Investigators
- John Levin, DPM, Principal investigator, JEM Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290586
- Sponsor's protocol ID
- FLO-001
- Status last verified
- Aug 2019
- First submitted
- 18 Sep 2017
- Last updated
- 8 Aug 2019
- 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 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis; the Evaluation of a Novel, Single Use Sterile, Disposable Delivery System
- ClinicalTrials.gov ID
- NCT03290586
- Acronym / sponsor ID
- FLO-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- JEM Research InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Flower Orthopedics
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 25 Sep 2017 (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.
This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \and hardware complications.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the surgeons' private practices. These patients have already met the criteria for surgical intervention and have agreed to undergo the operative procedure and postoperative management.
Key inclusion criteria (4 listed)
- Painful Hallux Limitus or Rigidus
- Painful Geriatric Hallux Valgus
- Failed prior 1st MTP joint arthroplasty (hemi-total)
- Arthritis of any etiology other than degenerative causes
Key exclusion criteria (7 listed)
- Age less than 18 years
- Pregnant Females
- Active or prior infection at the target joint
- Immunocompromised patients
- Patients unwilling to sign informed consent
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 |
|---|---|---|
| Flower Cubesingle use, sterile disposable fixation construct | Device | – |
Primary outcome
Union Rates
Time frame: 12 months
Confirm union rates comparable to existing outcomes complications with our proposed construct.
Hardware Failures
Time frame: 12 months
Evaluate hardware failures with our proposed construct.
Complications
Time frame: 12 months
Evaluate complications with the procedure
1 secondary outcome
Cost Data
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: No
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.
John Levin, DPM principal investigator
JEM Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First Metatarsophalangeal Joint Arthritis, run by JEM Research Institute at 1 site in United States.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 8 Aug 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Union Rates (time frame: 12 months). The study lists 3 primary outcomes in all. 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 8 Aug 2019.