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

December 20, 2021 updated by: National Taiwan University Hospital
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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?"

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent operations for lesser metatarsophalangeal joint instability between September 2015 and December 2019.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
symptomatic plantar plate rupture
plantar plate repair operation for symptomatic lesser metatarsophalangeal joint instability
Procedure: plantar plate repair
surgical repair via dorsal approach of lesser metatarsophalangeal joint general anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
post-operative >12 months
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.
pre-opreative and post-operative >12 months
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.
post-operative >12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
pre-opreative and post-operative >12 months
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.
pre-opreative and post-operative >12 months
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.
pre-opreative and post-operative >12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 24, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201909030RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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