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NCT05527197 · ClinicalTrials.gov registry record · NA
Patient Reported Function Following Combined First MTP and First TMT Arthrodesis.
A NA study of Hallux Valgus, sponsored by Midwest Bunion Center.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT05527197: Completed NA study of Hallux Valgus, sponsored by Midwest Bunion Center.
NCT05527197 is a NA study of Hallux Valgus that has completed, run by Midwest Bunion Center. The registered enrollment target is 31 participants, below the 76-participant average among 4 other Hallux Valgus trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05527197, a NA study of Hallux Valgus, has completed, sponsored by Midwest Bunion Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Patient responses in the Double Arthrodesis Sports Activities Related to Operative Foot Questionnaire and Sports Activities Related to Operative Foot Questionnaire
Conditions Studied
Interventions
- DEVICE Lapiplasty
Study Locations (1)
Iowa
- Foot and Ankle Center of Iowa - Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-03-29 |
| Est. Completion | 2023-08-30 |
| Phase | NA |
What the finished NCT05527197 record still lists
NCT05527197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 76-participant average among 4 other Hallux Valgus trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Hallux Valgus appearing as the primary indexed condition, and to 1 intervention - of which Lapiplasty is the first listed.
NCT05527197 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT05527197 about?
NCT05527197 is a clinical study titled "Patient Reported Function Following Combined First MTP and First TMT Arthrodesis.". 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...
What is the current status of trial NCT05527197?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2022-03-29. Estimated completion is 2023-08-30.
What conditions does trial NCT05527197 study?
This clinical trial studies the following conditions: Hallux Valgus.
What interventions are being tested in trial NCT05527197?
The interventions under investigation include: Lapiplasty (DEVICE).
Who is sponsoring clinical trial NCT05527197?
This trial is sponsored by Midwest Bunion Center, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05527197 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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