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N/A

Patient reported function of daily ADL's post combined first MTP/TMT joint arthrodesis for Bunions

N/A
Waitlist Available
Led By Paul M Dayton DPM FACFAS
Research Sponsored by Midwest Bunion Center, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks to 12 months
Awards & highlights

Study Summary

This trial is assessing the feasibility of conducting a larger study to compare the outcomes of two different surgical procedures for treating a deformity in the foot.

Eligible Conditions
  • Bunions

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient reported level of activity and satisfaction based on functional surveys
Secondary outcome measures
Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis
Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis
Comparison of Pre-Operative and Post-Operative Radiographic Alignment
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patient reported function of daily ADL's post combined first MTP/TMT joint arthrodesisExperimental Treatment1 Intervention
Patients that meet the inclusion criteria will be contacted for participation in the study. If the patient agrees to participate in the study, informed consent will be obtained. The retrospective study will consist of a chart review and baseline radiographic analysis. The prospective follow-up will consist of the patient completing the Post-Operative Function and Satisfaction Survey via phone call with study staff. Radiographic images will be analyzed by a single central radiologist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lapiplasty
2022
N/A
~40

Find a Location

Who is running the clinical trial?

Midwest Bunion Center, LLCLead Sponsor
Paul M Dayton DPM FACFASPrincipal InvestigatorFoot & Ankle Center of Iowa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my eligibility in accordance with the parameters of this trial?

"To qualify for this clinical trial, applicants must have hallux valgus and be aged 18 to 80. A total of 75 participants are required in order to move forward with the study."

Answered by AI

Is this experiment currently seeking participants?

"Indeed, the clinicaltrials.gov website attests to the fact that this medical experiment is actively looking for participants. It was posted on March 29th 2022 and has been revised more recently on September 1st 2022. Specifically, 75 individuals need to be sourced from a single test site."

Answered by AI

How many individuals are currently taking part in the research?

"Affirmative. The information hosted on clinicaltrials.gov establishes that this research project is actively seeking participants, which was first posted on March 29th 2022 and recently updated September 1st 2022. 75 individuals will be selected from one medical site for the trial."

Answered by AI

Does this trial include participants of a younger demographic?

"This trial requires that participants are aged between 18 and 80. For those below the age of consent, there are 3 studies available, whereas 15 have been specifically designed for older patients over 65 years old."

Answered by AI
~10 spots leftby Apr 2025