Adult-acquired Flatfoot Disorder (AAFD)WBCTNCT01868789
Weightbearing Assessment of Tarsal Instability
A study testing Weightbearing CT in people with Adult-acquired Flatfoot Disorder (AAFD), run by Orthopedic Foot and Ankle Center, Ohio at 1 site in United States.
Trial summary
The purpose of this study is to compare the average joint motion and joint axis orientation of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder (AAFD) and a control group of patients without foot deformity, using weight-bearing CT technology. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult-acquired Flatfoot Disorder (AAFD)
- What is being tested?
- Weightbearing CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. adult patients (ages 18 -80 years old) diagnosed with Stage 2 AAFD
- 1. adult patients (ages 18 -80 years old) without foot deformity
Who cannot join
- previous surgery
- infection
- tumor in the affected foot
- pregnancy
- Control group:
- history of previous foot and ankle surgery
Show all 9Show fewer
- foot deformity
- known foot and ankle pathology
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopedic Foot and Ankle Center
Westerville, Ohio, 43082
About this study
Official title: In-Vivo Physiologic Weight-Bearing Assessment of Tarsal Instability: Three-Dimensional Cone-Beam Computed Tomography Analysis
The purpose of this study is to compare the average joint motion and joint axis orientation of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder (AAFD) and a control group of patients without foot deformity, using weight-bearing CT technology.
- Conditions
- Adult-acquired Flatfoot Disorder (AAFD)
- Being tested
- Weightbearing CT
- Keywords
- Adult-acquired flatfoot disorder (AAFD), flexible flatfoot, computed tomography (CT)
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weightbearing CTRadiation
| Study group | Role | What they receive |
|---|---|---|
| Weightbearing CT (AAFD group) | Experimental | Weightbearing CT scan of affected foot Receives: Radiation: Weightbearing CT |
| Weightbearing CT (control group) | Active comparator | Weightbearing CT scan of normal foot Receives: Radiation: Weightbearing CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular
Relative motion, which is the position of the full weightbearing (FWB, greater that 75-100% body weight) navicular in comparison to the touch down weightbearing (TDWB, 25-50% body weight) navicular position, will be determined by comparing the joint orientation across these two points on one CT scan. The difference between the two positions is reported below.
Measured: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing
Relative motion across joint segments will be determined by comparing the joint orientation across two time points: touch-down bearing (TDWB, 25-50% body weight) and full-weight bearing (FWB, greater that 75-100% body weight) as measured on CT.
Measured: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult-acquired Flatfoot Disorder (AAFD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopedic Foot and Ankle Center, Ohio
- Sponsor type
- University, hospital or other
- Collaborators
- CurveBeam LLC
- Responsible party
- Sponsor
- Investigators
- Gregory C Berlet, MD, Principal investigator, Orthopedic Foot and Ankle Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868789
- Sponsor's protocol ID
- OH1-12-00397
- Acronym
- WBCT
- Status last verified
- Jan 2018
- First submitted
- 24 May 2013
- Last updated
- 1 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vivo Physiologic Weight-Bearing Assessment of Tarsal Instability: Three-Dimensional Cone-Beam Computed Tomography Analysis
- ClinicalTrials.gov ID
- NCT01868789
- Acronym / sponsor ID
- WBCT / OH1-12-00397
- Conditions
- Adult-acquired Flatfoot Disorder (AAFD)
- Keywords
- Adult-acquired flatfoot disorder (AAFD), flexible flatfoot, computed tomography (CT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Orthopedic Foot and Ankle Center, OhioUniversity, hospital or other
- Collaborators
- CurveBeam LLC
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Posted 18 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the average joint motion and joint axis orientation of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder (AAFD) and a control group of patients without foot deformity, using weight-bearing CT technology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weightbearing CT (AAFD group) | Experimental | Radiation: Weightbearing CTWeightbearing CT scan of affected foot |
| Weightbearing CT (control group) | Active comparator | Radiation: Weightbearing CTWeightbearing CT scan of normal foot |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. adult patients (ages 18 -80 years old) diagnosed with Stage 2 AAFD
- 1. adult patients (ages 18 -80 years old) without foot deformity
Key exclusion criteria (9 listed)
- previous surgery
- infection
- tumor in the affected foot
- pregnancy
- history of previous foot and ankle surgery
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 |
|---|---|---|
| Weightbearing CT | Radiation | Weightbearing CT (AAFD group), Weightbearing CT (control group) |
Primary outcome
Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular
Time frame: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
Relative motion, which is the position of the full weightbearing (FWB, greater that 75-100% body weight) navicular in comparison to the touch down weightbearing (TDWB, 25-50% body weight) navicular position, will be determined by comparing the joint orientation across these two points on one CT scan. The difference between the two positions is reported below.
Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing
Time frame: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
Relative motion across joint segments will be determined by comparing the joint orientation across two time points: touch-down bearing (TDWB, 25-50% body weight) and full-weight bearing (FWB, greater that 75-100% body weight) as measured on CT.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Adult-acquired Flatfoot Disorder (AAFD)
RecruitingPhase 4
Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult Acquired Flatfoot Deformity
Acquired Adult Flatfoot Deformity, Flat Foot
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.
Gregory C Berlet, MD principal investigator
Orthopedic Foot and Ankle Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weightbearing CT in people with Adult-acquired Flatfoot Disorder (AAFD), run by Orthopedic Foot and Ankle Center, Ohio 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 2 inclusion and 9 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 1 Mar 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 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?
Yes. Results are posted in the registry (first posted 18 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular (time frame: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing). The study lists 2 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 1 Mar 2018.