Clinical trial NCT04949685: Evaluation of Clinical and Functional Results After Operative Correction of Lesser Toe Deformities
Official title: Evaluation of Clinical and Functional Results After Operative Correction of Lesser Toe Deformities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plantar Plate Tear
Metatarsalgia
Lesser Metatarsophalangeal Joint Instability
Hammer Toe
Surgery
Plantar Plate Repair
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent operations for lesser metatarsophalangeal joint instability between September 2015 and December 2019.

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

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?"

Eligibility 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

Primary outcomes:
measure: Lesser Metatarsophalangeal-Interphalangeal Scale from the Americans Orthopedic Foot and Ankle Society (AOFAS) forefoot score (0-100 points)
timeFrame: post-operative >12 months
measure: Visual Analogue Scale score (VAS) for pain (0-10 points)
timeFrame: pre-opreative and post-operative >12 months
measure: Visual Analogue Scale score for satisfaction (0-10 points)
timeFrame: post-operative >12 months
Secondary outcomes:
measure: hallux valgus angle (degree)
timeFrame: pre-opreative and post-operative >12 months
measure: 1-2 intermetatarsal angle (degree)
timeFrame: pre-opreative and post-operative >12 months
measure: Metatarsophalangeal joint angle( for lesser toes, degree)
timeFrame: pre-opreative and post-operative >12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
citation: Coughlin MJ. Crossover second toe deformity. Foot Ankle. 1987 Aug;8(1):29-39. doi: 10.1177/107110078700800108.
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.
citation: 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.