Clinical trial NCT02074748: Measurement of Arch Motion After Bunion Surgery
Official title: First Ray Kinematics Following Lapidus Bunion Surgery: A Fluoroscopic Gait Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hallux Valgus
Instability of the Foot Arch
Keywords: Bunion
Foot Arch
Instability
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fluoroscopy Examination of the Foot.
timeFrame: Change in Outcome Measurement [presurgery (baseline) and again 6 months postsurgery]
Secondary outcomes:
measure: Device Measurement of Arch Motion.
timeFrame: Change in Outcome Measurement. [presurgery (baseline) and again 6 months postsurgery]
Other outcomes:
measure: Medical Questionnaires.
timeFrame: Change in Outcome Measurements. [presurgery (baseline) and again at 3 months, 6 months, and 12 months postsurgery]
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ward M Glasoe, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: