Surgery Clinical Trial
Official title:
Evaluation of Clinical and Functional Results After Operative Correction of Lesser Toe Deformities
Verified date | October 2020 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
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
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 |
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