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NCT Number: NCT04949685

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

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

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Key information

Conditions

Plantar Plate Tear Foot Deformities Foot Diseases Hammer Toe Hammer Toe Syndrome Joint Diseases Lesser Metatarsophalangeal Joint Instability Metatarsalgia Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Plantar Plate Repair Signs and Symptoms Surgery

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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?"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

plantar plate repair

Procedure

surgical repair via dorsal approach of lesser metatarsophalangeal joint general anesthesia

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. hallux valgus angle (degree)

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

    Hallux valgus angle is the angle between the axis of the 1st metatarsal and the axis of the proximal phalanx of the 1st toe. It can only be measured on a radiograph performed whilst weight bearing.

    In this study, pre-operative and post-operative hallux valgus angle were obtained for evaluating the operative outcome.

  2. 1-2 intermetatarsal angle (degree)

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

    1-2 intermetatarsal angle is the angle between the axis of the 1st metatarsal and the axis of the 2nd metatarsal. It can only be measured on a radiograph performed whilst weight bearing.

    In this study, pre-operative and post-operative hallux valgus angle were obtained for evaluating the operative outcome.

  3. Metatarsophalangeal joint angle( for lesser toes, degree)

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

    Metatarsophalangeal joint angle is the angle between the axis of the metatarsal and the axis of the proximal phalanx of the lesser toe. It can only be measured on a radiograph performed whilst weight bearing. positive angle indicates a lateral inclination, and negative angle denotes a varus inclination.

    In this study, pre-operative and post-operative hallux valgus angle were obtained for evaluating the operative outcome.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2021
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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