Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04949685
Recruitment Status : Recruiting
First Posted : July 2, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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

Condition or disease Intervention/treatment
Plantar Plate Tear Metatarsalgia Lesser Metatarsophalangeal Joint Instability Hammer Toe Surgery Plantar Plate Repair Procedure: 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?"

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of Clinical and Functional Results After Operative Correction of Lesser Toe Deformities
Actual Study Start Date : November 25, 2019
Estimated Primary Completion Date : November 24, 2021
Estimated Study Completion Date : November 24, 2021

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent operations for lesser metatarsophalangeal joint instability between September 2015 and December 2019.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04949685


Contacts
Layout table for location contacts
Contact: Pei-Yu Chen, MD,PhD +88623123456 ext 2137 f92548050@gmail.com
Contact: Shun-Min Chang, MD +886935039300 dtorth758@gmail.com

Locations
Layout table for location information
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Pei-Yu Chen, MD,PhD    +88623123456 ext 2137    f92548050@gmail.com   
Contact: Shun-Min Chang, MD    +886935039300    dtorth758@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Publications of Results:
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04949685    
Other Study ID Numbers: 201909030RIND
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Instability
Metatarsalgia
Hammer Toe Syndrome
Joint Diseases
Musculoskeletal Diseases
Foot Diseases
Pain
Neurologic Manifestations
Foot Deformities