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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949685
• Other study ID #: 201909030RIND
• Status: Completed
• Start date: November 25, 2019
• Est. completion date: November 24, 2021

Study information

• Verified date: October 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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?"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 24, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hammer Toe
• Joint Instability
• Metatarsalgia
• Plantar Plate Tear
• Surgery

Intervention

Procedure:
• plantar plate repair
surgical repair via dorsal approach of lesser metatarsophalangeal joint general anesthesia

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Coughlin MJ. Crossover second toe deformity. Foot Ankle. 1987 Aug;8(1):29-39. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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