Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis

Not Applicable

Completed

• Conditions: Knee Deformity
• Interventions: Procedure: Eight plate hemiepiphysiodesis

• Registration Number: NCT03689959
• Lead Sponsor: Assiut University

Brief Summary

The study aims to assess the effectiveness of hemiephysiodesis using eight plates in correction of fixed knee flexion deformities in children.

Detailed Description

Flexion contractures of the knee are quite disabling. They produce deleterious effects on knee biomechanics, quadriceps function, energy expenditure during gait and the overall ability to ambulate. These deformities occur secondary to a number of different etiologies including; congenital, traumatic, inflammatory and neuromuscular disorders with cerebral palsy (CP) being on the top of the list.

The main aim of correction of sagittal plane deformities of the knee is to restore the range of motion. Surgical options available for correction of knee flexion contractures include soft tissue modification, acute correction by osteotomies, gradual correction by external fixators and growth modulation by hemiephysiodesis.Extensive soft tissue surgery may be needed for correction of knee deformities with potential risk of neurovascular damage and wound complications. Supracondylar extension osteotomies have been widely used, however prolonged immobilization and associated neurovascular insults have always been major concerns. External fixators are cumbersome and may produce muscle tethering and pin tract infections.

There are few studies in the literature reporting the use of anterior hemiepiphysiodesis for correction of knee flexion contracture.

Our study question can be summarized as follows; Is hemiepiphysiodesis by eight plates effective for correction of fixed knee flexion deformities in children ?

Study Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Study Start: 2018-11-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Fixed knee flexion deformity more than 10°
• Unilateral or bilateral cases
• 12 months or more predicted growth remaining
• No response to non-operative treatment (physical therapy, bracing, casting);
• Recurrent cases

Exclusion Criteria

• Dynamic deformities due to spasticity
• Deformities responding to conservative treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Eight plate hemiepiphysiodesis	13 child with fixed knee flexion deformity more than 10° on one or both sides with 12 months or more predicted growth remaining subjected to eight plate hemiepiphysiodesis of the distal femur

Primary Outcome Measures

Name	Time	Method
Degree of flexion deformity	One year	The angle between the anterior borders of thigh and leg measured clinically with a goniometer

Secondary Outcome Measures

Name	Time	Method
Complications	One year	Wound complications, metal failure
Rate of correction	One year	Time needed for correction of deformity

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt