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Clinical Trials/NCT04949685
NCT04949685
Completed
Not Applicable

Evaluation of Clinical and Functional Results After Operative Correction of Lesser Toe Deformities

National Taiwan University Hospital1 site in 1 country18 target enrollmentNovember 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Plantar Plate Tear
Sponsor
National Taiwan University Hospital
Enrollment
18
Locations
1
Primary Endpoint
Lesser Metatarsophalangeal-Interphalangeal Scale from the Americans Orthopedic Foot and Ankle Society (AOFAS) forefoot score (0-100 points)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The plantar plate is an important static stabilizer of lesser metatarsophalangeal joints, and disruptions of the plantar plate can lead to significant instability and lesser toe deformities.Our study proposes an inexpensive and versatile method for plantar plate repair

Detailed Description

A torn plantar plate is small and difficult to access using regular instruments in a restricted operative field. A unique method for plantar plate repairs was used to repair various configurations of plantar plate tears with standard operative instruments that is available in most operating rooms. A retrospective study was performed on patients who underwent operations for lesser MTPJ instability between September 2015 and December 2019. The outcome analysis included the Lesser Metatarsophalangeal-Interphalangeal Scale from the American Orthopedic Foot and Ankle Society (AOFAS) forefoot score, the Visual Analogue Scale score for pain and satisfaction, and answering the question "Would you recommend this procedure to other patients?"

Registry
clinicaltrials.gov
Start Date
November 25, 2019
End Date
November 24, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of lesser metatarsophalangeal joint instability
  • Clinical diagnosis of metatarsalgia
  • Lesser metatarsophalangeal joint instability clinical grades of II to III, which were determined using the drawer test.

Exclusion Criteria

  • Previous operatve treatment of the affected lesser metatarsophalangeal joint.
  • Rheumatioid arthritis.
  • Neurologic disorders (e.g., parkinsonism, Charcot's neuroarthropathy...etc.).
  • Postoperative follow-ups of less than 12 months

Outcomes

Primary Outcomes

Lesser Metatarsophalangeal-Interphalangeal Scale from the Americans Orthopedic Foot and Ankle Society (AOFAS) forefoot score (0-100 points)

Time Frame: post-operative >12 months

One of the most widely used PRO measures for foot and ankle conditions is the American Orthopedic Foot and Ankle Society Score (AOFAS). Developed in 1994, the clinician-based AOFAS covers four different regions of the foot: The ankle-hindfoot, midfoot, metatarsophalangeal (MTP)-interphalangeal (IP) for the hallux, and MTP-IP for the lesser toes. These four anatomic regions have their own version of the AOFAS survey. Each c is designed to be used independent of the others. However, each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points.

Visual Analogue Scale score (VAS) for pain (0-10 points)

Time Frame: pre-opreative and post-operative >12 months

The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this study, pre-operative VAS score and post-operative score for pain were obtained for evaluating the clinical outcome. "0" means no pain; "10" means very painful.

Visual Analogue Scale score for satisfaction (0-10 points)

Time Frame: post-operative >12 months

The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this study, pre-operative VAS score and post-operative score for satisfaction were obtained for evaluating the clinical outcome. "0" means unsatisfied ; "10" means very satisfied.

Secondary Outcomes

  • hallux valgus angle (degree)(pre-opreative and post-operative >12 months)
  • 1-2 intermetatarsal angle (degree)(pre-opreative and post-operative >12 months)
  • Metatarsophalangeal joint angle( for lesser toes, degree)(pre-opreative and post-operative >12 months)

Study Sites (1)

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