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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05170698
Other study ID # 0000017585
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 18, 2018
Est. completion date December 30, 2021

Study information

Verified date June 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 .


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 30, 2021
Est. primary completion date December 18, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 20 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Egypt Ain shams university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other AOFAS he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function preoperative
Other AOFAS he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function three months
Other AOFAS he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function six months
Other AOFAS he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function one year
Other AOFAS he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function two year
Primary Degree of deformity valgus By goniometer preoperative
Primary Degree of deformity valgus By goniometer three months
Primary Degree of deformity valgus By goniometer six months
Primary Degree of deformity valgus By goniometer one year postoperative
Primary Degree of deformity valgus By goniometer two year postoperative
Primary Subtalar range of motion By geniometer for inversion and eversion preoperative
Primary Subtalar range of motion By geniometer for inversion and eversion three months
Primary Subtalar range of motion By geniometer for inversion and eversion six months
Primary Subtalar range of motion By geniometer for inversion and eversion one year postoperative
Primary Subtalar range of motion By geniometer for inversion and eversion two year postoperative
Secondary functional outcome By foot ankle ability measurement score preoperative
Secondary Patient satisfaction By foot and ankle disability score preoperative
Secondary functional outcome By foot ankle ability measurement score three months
Secondary Patient satisfaction By foot and ankle disability score three months
Secondary functional outcome By foot ankle ability measurement score six months
Secondary Patient satisfaction By foot and ankle disability score six months
Secondary functional outcome By foot ankle ability measurement score one year
Secondary functional outcome By foot ankle ability measurement score two year
Secondary Patient satisfaction By foot and ankle disability score one year
Secondary Patient satisfaction By foot and ankle disability score two year
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