Measurement of Arch Motion After Bunion Surgery

NCT ID: NCT02074748

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-12-31

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.

Conditions

Hallux Valgus; Instability of the Foot Arch

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Bunion

Patients being treated for foot bunion with surgery.

No interventions assigned to this group

Controls (normal foot)

Participants in this group will not undergo surgery.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ward M Glasoe, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1401M47629

Identifier Type: -

Identifier Source: org_study_id