Hallux ValgusNCT02074748
Measurement of Arch Motion After Bunion Surgery
An observational study of Hallux Valgus and Instability of the Foot Arch, run by University of Minnesota at 1 site in United States.
Trial summary
This study is an observational "change from baseline" outcome measures design. Data is collected for the sake of evaluating treatment (fusion surgery) performed as standard medical care, but the investigator does not assign specific interventions to any participants in this study. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus, Instability of the Foot Arch
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2015
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients having bunion will be recruited from the surgical practice of the Co-I. The surgeon will screen the patients, and invite those to participate identified as having an unstable arch as a complication of bunion deformity. Controls will be recruited from the community, group matched for age. Controls must have normal foot posture and display no evidence of an unstable arch.
Who may be able to join
- Age 18 or older.
- Women.
- Able to comprehend the risks associated with the study.
- Able to complete the paperwork required for enrollment.
- Able to walk without assistance of another individual.
Who cannot join
- Pregnancy
- History of great toe, forefoot or arch surgery, or severe traumatic injury.
- Reduced ankle or great toe motion that impairs the ability to walk.
- Observed evidence of foot deformity other than bunion.
- Insensate to skin sensation testing which could indicate neuropathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: First Ray Kinematics Following Lapidus Bunion Surgery: A Fluoroscopic Gait Study
This study is an observational "change from baseline" outcome measures design. Data is collected for the sake of evaluating treatment (fusion surgery) performed as standard medical care, but the investigator does not assign specific interventions to any participants in this study.
Read the detailed description
Device/fluoroscopy measurements of arch motion and questionnaire data will be acquired on 10 women undergoing surgery for bunion, and 10 controls. Surgery will implant hardware to fuse (stabilize) the arch. Methods will evaluate the patient's problems associated with bunion and satisfaction with surgery, and assess the effectiveness of surgery in reducing motion of the arch. The hypotheses are that patients treated with surgery will demonstrate improvement in function, and that surgery will reduce motion of the arch postoperatively (posttest measures acquired 6 months after surgery), and in comparison to measures taken on a control group.
The data collected will come from a comprehensive examination. Methods will include the measurement of arch motion made by an examiner using a device and a fluoroscopic gait examination procedure, and completion of two medical questionnaires. The fluoroscopic acquisition of the digital images will be analyzed across the specified time dimensions of the gait cycle.
Device and fluoroscopy of measures of arch motion will be made at 2 time points on patients enrolled in this study: presurgery (baseline) and 6 months postsurgery. The questionnaire measurements of self-reported pain and function will be made at 4 time points: presurgery (baseline) and again at 3 months, 6 months, and 12 months postsurgery. Outcome measurements will be collected on control subjects at one time point only, on the day of their enrollment into the study.
Prospective studies have not characterized outcomes in patients receiving this type surgical fusion as part of the corrective treatment for bunion. Results have potential to improve surgical treatment outcomes and, improve upon the current methods of fluoroscopic motion analysis.
- Conditions
- Hallux Valgus, Instability of the Foot Arch
- Keywords
- Bunion, Foot Arch, Instability
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Bunion | Patients being treated for foot bunion with surgery. | |
| Controls (normal foot) | Participants in this group will not undergo surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoroscopy Examination of the Foot.
Fluoroscopic examination will image the foot during the roll-over phase of the gait. The participant will step in slow motion in front of the fluoroscopic x-ray beam to record the change in the position of the arch at specified gait-event time dimensions. Image acquisition will be at 25 frames per second lasting no longer than 2 seconds. All participants will wear leaded clothing in accordance with a protocol approved by the Univ of Minnesota Department of Health and Safety, Radiation Protection Division.
Fluoroscopy "change in outcome measures" of arch motion will be made at 2 time points on all patients who participate: presurgery (baseline) and again 6 months postsurgery.
Fluoroscopy measures will be acquired on control subjects at one time point only, on the day of their enrollment into the study.
Measured: Change in Outcome Measurement [presurgery (baseline) and again 6 months postsurgery]
Secondary outcomes (1)
Device Measurement of Arch Motion.
Device measurement of arch motion will be acquired using the device built for this one purpose. Device measurements will be made on the both feet.
Device "change in outcome measurement" of arch motion will be made a 2 time points on all patients: presurgery (baseline) and again 6 months postsurgery.
Device measures of arch motion will be acquired on control subjects at one time point only, on the day their enrollment into the study.
Measured: Change in Outcome Measurement. [presurgery (baseline) and again 6 months postsurgery]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Surgeons chose not to provide patients for testing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ward M Glasoe, PhD, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074748
- Sponsor's protocol ID
- 1401M47629
- Status last verified
- Oct 2019
- First submitted
- 18 Feb 2014
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Ray Kinematics Following Lapidus Bunion Surgery: A Fluoroscopic Gait Study
- ClinicalTrials.gov ID
- NCT02074748
- Acronym / sponsor ID
- 1401M47629
- Conditions
- Hallux Valgus, Instability of the Foot Arch
- Keywords
- Bunion, Foot Arch, Instability
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Surgeons chose not to provide patients for testing
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Feb 2014 (estimated)
- 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 study is an observational "change from baseline" outcome measures design. Data is collected for the sake of evaluating treatment (fusion surgery) performed as standard medical care, but the investigator does not assign specific interventions to any participants in this study.
Detailed description
Device/fluoroscopy measurements of arch motion and questionnaire data will be acquired on 10 women undergoing surgery for bunion, and 10 controls. Surgery will implant hardware to fuse (stabilize) the arch. Methods will evaluate the patient's problems associated with bunion and satisfaction with surgery, and assess the effectiveness of surgery in reducing motion of the arch. The hypotheses are that patients treated with surgery will demonstrate improvement in function, and that surgery will reduce motion of the arch postoperatively (posttest measures acquired 6 months after surgery), and in comparison to measures taken on a control group.
The data collected will come from a comprehensive examination. Methods will include the measurement of arch motion made by an examiner using a device and a fluoroscopic gait examination procedure, and completion of two medical questionnaires. The fluoroscopic acquisition of the digital images will be analyzed across the specified time dimensions of the gait cycle.
Device and fluoroscopy of measures of arch motion will be made at 2 time points on patients enrolled in this study: presurgery (baseline) and 6 months postsurgery. The questionnaire measurements of self-reported pain and function will be made at 4 time points: presurgery (baseline) and again at 3 months, 6 months, and 12 months postsurgery. Outcome measurements will be collected on control subjects at one time point only, on the day of their enrollment into the study.
Prospective studies have not characterized outcomes in patients receiving this type surgical fusion as part of the corrective treatment for bunion. Results have potential to improve surgical treatment outcomes and, improve upon the current methods of fluoroscopic motion analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bunion | – | –Patients being treated for foot bunion with surgery. |
| Controls (normal foot) | – | –Participants in this group will not undergo surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having bunion will be recruited from the surgical practice of the Co-I. The surgeon will screen the patients, and invite those to participate identified as having an unstable arch as a complication of bunion deformity. Controls will be recruited from the community, group matched for age. Controls must have normal foot posture and display no evidence of an unstable arch.
Key inclusion criteria (5 listed)
- Age 18 or older.
- Women.
- Able to comprehend the risks associated with the study.
- Able to complete the paperwork required for enrollment.
- Able to walk without assistance of another individual.
Key exclusion criteria (5 listed)
- Pregnancy
- History of great toe, forefoot or arch surgery, or severe traumatic injury.
- Reduced ankle or great toe motion that impairs the ability to walk.
- Observed evidence of foot deformity other than bunion.
- Insensate to skin sensation testing which could indicate neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fluoroscopy Examination of the Foot.
Time frame: Change in Outcome Measurement [presurgery (baseline) and again 6 months postsurgery]
Fluoroscopic examination will image the foot during the roll-over phase of the gait. The participant will step in slow motion in front of the fluoroscopic x-ray beam to record the change in the position of the arch at specified gait-event time dimensions. Image acquisition will be at 25 frames per second lasting no longer than 2 seconds. All participants will wear leaded clothing in accordance with a protocol approved by the Univ of Minnesota Department of Health and Safety, Radiation Protection Division. Fluoroscopy "change in outcome measures" of arch motion will be made at 2 time points on all patients who participate: presurgery (baseline) and again 6 months postsurgery. Fluoroscopy measures will be acquired on control subjects at one time point only, on the day of their enrollment into the study.
1 secondary outcome
Device Measurement of Arch Motion.
Time frame: Change in Outcome Measurement. [presurgery (baseline) and again 6 months postsurgery]
Results and safety
The study was stopped early (reason given: Surgeons chose not to provide patients for testing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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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.
Ward M Glasoe, PhD, PT principal investigator
University of Minnesota
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 Hallux Valgus and Instability of the Foot Arch, run by University of Minnesota 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Nov 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 was stopped early (reason given: Surgeons chose not to provide patients for testing). Results are not available in the source record.
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?
Fluoroscopy Examination of the Foot. (time frame: Change in Outcome Measurement [presurgery (baseline) and again 6 months postsurgery]). 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 Nov 2019.