Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis
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|ClinicalTrials.gov Identifier: NCT03689959|
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Knee Deformity||Procedure: Eight plate hemiepiphysiodesis||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||February 2022|
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
Procedure: Eight plate hemiepiphysiodesis
Patient is positioned in a classic supine position. Under fluoroscopic guidance and tourniquet hemostasis, the distal femoral physis is identified. Two 3-cm incisions are made, one on either side of the patella, centred at the level of the physis. The capsule and synovium are opened to visualize the sulcus and place the plates just outside the articular portion of the joint surface, medially and laterally. Care is taken not to damage the periosteum and a needle is inserted into the physis. The 8-plate, which has a central hole, is slipped over the needle and screws inserted. After wound closure, a soft dressing is used, and the patient is allowed to ambulate as tolerated.
Other Name: Guided growth
- Degree of flexion deformity [ Time Frame: One year ]The angle between the anterior borders of thigh and leg measured clinically with a goniometer
- Complications [ Time Frame: One year ]Wound complications, metal failure
- Rate of correction [ Time Frame: One year ]Time needed for correction of deformity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689959
|Contact: Mohamed Y. Hassanein, M.Sc.||+firstname.lastname@example.org|
|Assiut University Hospital||Recruiting|
|Assiut, Egypt, 71111|
|Contact: Mohamed Y. Hassanein, Msc. +201008084749 email@example.com|
|Principal Investigator:||Mohamed Y. Hassanein, M.Sc.||Assiut University|