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

Study Overview

• Status: Completed
• Conditions: Surgery; Metatarsalgia; Hammer Toe; Plantar Plate Tear; Lesser Metatarsophalangeal Joint Instability; Plantar Plate Repair
• Intervention / Treatment: 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?"

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure	Measure Description	Time Frame
hallux valgus angle (degree)	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)	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)	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

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• Coughlin MJ. Crossover second toe deformity. Foot Ankle. 1987 Aug;8(1):29-39. doi: 10.1177/107110078700800108.
• Weil L Jr, Sung W, Weil LS Sr, Malinoski K. Anatomic plantar plate repair using the Weil metatarsal osteotomy approach. Foot Ankle Spec. 2011 Jun;4(3):145-50. doi: 10.1177/1938640010397342. Epub 2011 Mar 18.
• Chang SM, Huang PJ, Farn CJ, Lin SY, Wang CC, Wang CL, Chen PY. A versatile method for dorsal-approach plantar plate repair using standard operative instruments. BMC Musculoskelet Disord. 2022 Jan 3;23(1):11. doi: 10.1186/s12891-021-04951-w.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): November 24, 2021

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Foot Deformities; Joint Instability; Hammer Toe Syndrome; Metatarsalgia
• Other Study ID 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