Treatment for Hallux Valgus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Foot and Ankle Center of Iowa, Des Moines, IA
Hallux Valgus
Eligibility
18+
All Sexes
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Study Summary

The goal of the study is to gather sufficient patient data to assess real world postoperative function after a first metatarsophalangeal (MTP) joint arthrodesis done in conjunction with first tarsometatarsal arthrodesis (TMT) (double fusion). Many studies have demonstrated the success of a first MTP joint arthrodesis in eliminating pain and reducing the intermetatarsal angle. Very little research has been published to assess the outcomes of double arthrodesis. Limited research has specifically assessed patients' everyday function and gait following MTP arthrodesis and no studies are available to assess real world function following double arthrodesis. More data that includes patient reported function during activities of daily living is needed to understand the benefits and draw backs of combined first MTP/TMT joint arthrodesis used to treat and correct first ray deformity.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hallux Valgus

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 6 weeks to 12 months

0-12 weeks
Time to start of weight-bearing in shoe
0-3 weeks
Time to start of weight-bearing in boot
12 months post procedure
Patient reported level of activity and satisfaction based on functional surveys
6 months post procedure
Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis
Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis
Radiographic Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis
Radiographic Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis
Month 12
Time to return to full unrestricted activity
Month 6
Comparison of Pre-Operative and Post-Operative Radiographic Alignment

Trial Safety

Safety Progress

1 of 3

Other trials for Hallux Valgus

Trial Design

0 Treatment Group

75 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks to 12 months
Closest Location: Foot and Ankle Center of Iowa · Des Moines, IA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Hallux Valgus
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Previous double joint arthrodesis procedure (Lapiplasty® Procedure) between 2017-2021.
The procedure has been completed at least 12 months from the onset of the study.
You have a double joint arthrodesis procedure performed at least 6 months prior to this report.
You are willing to answer the Post-Operative Functional and Satisfaction Questionnaire via phone call.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.