Management of Pes Planovalgus With Talocalcaneal Coalition ,Osteotomy vs Arthroereisis

Coalition Excision and Corrective Osteotomies vs Coalition Excision and Arthroereisis in Management of Pes Planovalgus With Talocalcaneal Coalition in Adolescent

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

Study Overview

• Status: Completed
• Conditions: Pes Planus; Talocalcaneal Bar
• Intervention / Treatment: Procedure: Coaltion excision and arthroereisis; Procedure: Coalition excision and corrective osteotomies

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 .

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: coalition excision and arthroereisis; Talocalcaneal bar excision is done and then arthroereisis implant is applied in subtalar joint to correct rigid pes planovalgus in adolescent	Procedure: Coaltion excision and arthroereisis; Both done to treat rigid flat foot with talocalcaneal coalition. Talocalcaneal coalition excision and management of rigid pes planovalgus in adolescent; Other Names: Coalition excision and corrective osteotomies
Experimental: coalition excision and corrective osteotomies; Talocalcaneal bar excision is done and then according to degree of deformity either medial displacement calcaneal osteotomy or evans or cotton osteotomy is done or combined together to correct rigid pes planovalgus in adolescents	Procedure: Coalition excision and corrective osteotomies; Both done to treat rigid flat foot with talocalcaneal coalition. Talocalcaneal coalition excision and management of rigid pes planovalgus in adolescent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of deformity valgus	By goniometer	preoperative
Degree of deformity valgus	By goniometer	three months
Degree of deformity valgus	By goniometer	six months
Degree of deformity valgus	By goniometer	one year postoperative
Degree of deformity valgus	By goniometer	two year postoperative
Subtalar range of motion	By geniometer for inversion and eversion	preoperative
Subtalar range of motion	By geniometer for inversion and eversion	three months
Subtalar range of motion	By geniometer for inversion and eversion	six months
Subtalar range of motion	By geniometer for inversion and eversion	one year postoperative
Subtalar range of motion	By geniometer for inversion and eversion	two year postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional outcome	By foot ankle ability measurement score	preoperative
Patient satisfaction	By foot and ankle disability score	preoperative
functional outcome	By foot ankle ability measurement score	three months
Patient satisfaction	By foot and ankle disability score	three months
functional outcome	By foot ankle ability measurement score	six months
Patient satisfaction	By foot and ankle disability score	six months
functional outcome	By foot ankle ability measurement score	one year
functional outcome	By foot ankle ability measurement score	two year
Patient satisfaction	By foot and ankle disability score	one year
Patient satisfaction	By foot and ankle disability score	two year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
AOFAS	he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function	preoperative
AOFAS	he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function	three months
AOFAS	he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function	six months
AOFAS	he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function	one year
AOFAS	he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function	two year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: ayman m howeidy, professor, Ain Shams University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2018
• Primary Completion (Actual): December 18, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: 0000017585

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