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Completed

NCT Number: NCT03689959

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

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

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Key information

Conditions

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, 71111, Egypt

About this study

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 ?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eight plate hemiepiphysiodesis

Procedure

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 names: Guided growth

Primary outcomes

  1. Degree of flexion deformity

    Time frame: One year

    The angle between the anterior borders of thigh and leg measured clinically with a goniometer

Secondary outcomes

  1. Complications

    Time frame: One year

    Wound complications, metal failure

  2. Rate of correction

    Time frame: One year

    Time needed for correction of deformity

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 1, 2018
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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