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Management of Pes Planovalgus With Talocalcaneal Coalition ,Osteotomy vs Arthroereisis

Primary Purpose

Talocalcaneal Bar, Pes Planus

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Coaltion excision and arthroereisis
Coalition excision and corrective osteotomies
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Talocalcaneal Bar

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ain shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

coalition excision and arthroereisis

coalition excision and corrective osteotomies

Arm Description

Talocalcaneal bar excision is done and then arthroereisis implant is applied in subtalar joint to correct rigid pes planovalgus in adolescent

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

Outcomes

Primary Outcome Measures

Degree of deformity valgus
By goniometer
Degree of deformity valgus
By goniometer
Degree of deformity valgus
By goniometer
Degree of deformity valgus
By goniometer
Degree of deformity valgus
By goniometer
Subtalar range of motion
By geniometer for inversion and eversion
Subtalar range of motion
By geniometer for inversion and eversion
Subtalar range of motion
By geniometer for inversion and eversion
Subtalar range of motion
By geniometer for inversion and eversion
Subtalar range of motion
By geniometer for inversion and eversion

Secondary Outcome Measures

functional outcome
By foot ankle ability measurement score
Patient satisfaction
By foot and ankle disability score
functional outcome
By foot ankle ability measurement score
Patient satisfaction
By foot and ankle disability score
functional outcome
By foot ankle ability measurement score
Patient satisfaction
By foot and ankle disability score
functional outcome
By foot ankle ability measurement score
functional outcome
By foot ankle ability measurement score
Patient satisfaction
By foot and ankle disability score
Patient satisfaction
By foot and ankle disability score

Full Information

First Posted
June 27, 2021
Last Updated
June 1, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05170698
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2018 (Actual)
Primary Completion Date
December 18, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Talocalcaneal Bar, Pes Planus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
coalition excision and arthroereisis
Arm Type
Experimental
Arm Description
Talocalcaneal bar excision is done and then arthroereisis implant is applied in subtalar joint to correct rigid pes planovalgus in adolescent
Arm Title
coalition excision and corrective osteotomies
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Coaltion excision and arthroereisis
Other Intervention Name(s)
Coalition excision and corrective osteotomies
Intervention Description
Both done to treat rigid flat foot with talocalcaneal coalition. Talocalcaneal coalition excision and management of rigid pes planovalgus in adolescent
Intervention Type
Procedure
Intervention Name(s)
Coalition excision and corrective osteotomies
Intervention Description
Both done to treat rigid flat foot with talocalcaneal coalition. Talocalcaneal coalition excision and management of rigid pes planovalgus in adolescent
Primary Outcome Measure Information:
Title
Degree of deformity valgus
Description
By goniometer
Time Frame
preoperative
Title
Degree of deformity valgus
Description
By goniometer
Time Frame
three months
Title
Degree of deformity valgus
Description
By goniometer
Time Frame
six months
Title
Degree of deformity valgus
Description
By goniometer
Time Frame
one year postoperative
Title
Degree of deformity valgus
Description
By goniometer
Time Frame
two year postoperative
Title
Subtalar range of motion
Description
By geniometer for inversion and eversion
Time Frame
preoperative
Title
Subtalar range of motion
Description
By geniometer for inversion and eversion
Time Frame
three months
Title
Subtalar range of motion
Description
By geniometer for inversion and eversion
Time Frame
six months
Title
Subtalar range of motion
Description
By geniometer for inversion and eversion
Time Frame
one year postoperative
Title
Subtalar range of motion
Description
By geniometer for inversion and eversion
Time Frame
two year postoperative
Secondary Outcome Measure Information:
Title
functional outcome
Description
By foot ankle ability measurement score
Time Frame
preoperative
Title
Patient satisfaction
Description
By foot and ankle disability score
Time Frame
preoperative
Title
functional outcome
Description
By foot ankle ability measurement score
Time Frame
three months
Title
Patient satisfaction
Description
By foot and ankle disability score
Time Frame
three months
Title
functional outcome
Description
By foot ankle ability measurement score
Time Frame
six months
Title
Patient satisfaction
Description
By foot and ankle disability score
Time Frame
six months
Title
functional outcome
Description
By foot ankle ability measurement score
Time Frame
one year
Title
functional outcome
Description
By foot ankle ability measurement score
Time Frame
two year
Title
Patient satisfaction
Description
By foot and ankle disability score
Time Frame
one year
Title
Patient satisfaction
Description
By foot and ankle disability score
Time Frame
two year
Other Pre-specified Outcome Measures:
Title
AOFAS
Description
he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function
Time Frame
preoperative
Title
AOFAS
Description
he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function
Time Frame
three months
Title
AOFAS
Description
he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function
Time Frame
six months
Title
AOFAS
Description
he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function
Time Frame
one year
Title
AOFAS
Description
he American Orthopaedic Foot & Ankle Society (AOFAS) score up to 100 the higher the score the better function
Time Frame
two year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayman m howeidy, professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Ain shams university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25248861
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.
Results Reference
background
PubMed Identifier
24909804
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.
Results Reference
background

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Management of Pes Planovalgus With Talocalcaneal Coalition ,Osteotomy vs Arthroereisis

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