Clinical trial NCT05170698: Management of Pes Planovalgus With Talocalcaneal Coalition ,Osteotomy vs Arthroereisis
Official title: Coalition Excision and Corrective Osteotomies vs Coalition Excision and Arthroereisis in Management of Pes Planovalgus With Talocalcaneal Coalition in Adolescent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Talocalcaneal Bar
Pes Planus
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups one with the first intervention arthroereisis and bar excision the second with bar excision and osteotomies it may be one or multiple
Primary purpose: TREATMENT

Brief summary: the investigators compare the corrective osteotomies vs arthroereisis in management of talcalcaneal coalition in adolescents as regard the outcome to provide the best intervention for the patient

Detailed description: In talocalcaneal coalition management is controversial so in this study the invstigators try to compare techniques other than coalition excision only or fusion only by using two types of intervention including first coalition excision and multiple corrective osteotomies according to deformity as evans ,medial displacement calcaneal osteotomy and cotton osteotomy vs coalition excision and arthroereisis the investigators compare functional and radiological outcomes and complication to provide the best management for these patients .

Eligibility criteria: Inclusion Criteria:

* flat foot due to talocalcaneal coalition Symptomatic patient Resectable coalition Age between 10 and 20

Exclusion Criteria:

* flat foot of other etiology Age more than 20 Concurrent knee deformity unless corrected before surgery Extensive coalition more than 50 %of posterior facet

Primary outcomes:
measure: Degree of deformity valgus
timeFrame: preoperative
measure: Degree of deformity valgus
timeFrame: three months
measure: Degree of deformity valgus
timeFrame: six months
measure: Degree of deformity valgus
timeFrame: one year postoperative
measure: Degree of deformity valgus
timeFrame: two year postoperative
measure: Subtalar range of motion
timeFrame: preoperative
measure: Subtalar range of motion
timeFrame: three months
measure: Subtalar range of motion
timeFrame: six months
measure: Subtalar range of motion
timeFrame: one year postoperative
measure: Subtalar range of motion
timeFrame: two year postoperative
Secondary outcomes:
measure: functional outcome
timeFrame: preoperative
measure: Patient satisfaction
timeFrame: preoperative
measure: functional outcome
timeFrame: three months
measure: Patient satisfaction
timeFrame: three months
measure: functional outcome
timeFrame: six months
measure: Patient satisfaction
timeFrame: six months
measure: functional outcome
timeFrame: one year
measure: functional outcome
timeFrame: two year
measure: Patient satisfaction
timeFrame: one year
measure: Patient satisfaction
timeFrame: two year
Other outcomes:
measure: AOFAS
timeFrame: preoperative
measure: AOFAS
timeFrame: three months
measure: AOFAS
timeFrame: six months
measure: AOFAS
timeFrame: one year
measure: AOFAS
timeFrame: two year
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: Ain Shams University
name: ayman m howeidy, professor
role: STUDY_CHAIR
References:
citation: El Shazly O, Mokhtar M, Abdelatif N, Hegazy M, El Hilaly R, El Zohairy A, Tawfik E. Coalition resection and medial displacement calcaneal osteotomy for treatment of symptomatic talocalcaneal coalition: functional and clinical outcome. Int Orthop. 2014 Dec;38(12):2513-7. doi: 10.1007/s00264-014-2535-3. Epub 2014 Sep 25.
citation: Siddiqui NA, Lamm BM. Digital planning for foot and ankle deformity correction: Evans osteotomy. J Foot Ankle Surg. 2014 Nov-Dec;53(6):700-5. doi: 10.1053/j.jfas.2014.04.011. Epub 2014 Jun 6.