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

July 18, 2023 updated by: Mohamed Yahya Abdel Azeem Hassanein, Assiut University
The study aims to assess the effectiveness of hemiephysiodesis using eight plates in correction of fixed knee flexion deformities in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
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 Names:
  • Guided growth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of flexion deformity
Time Frame: One year
The angle between the anterior borders of thigh and leg measured clinically with a goniometer
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: One year
Wound complications, metal failure
One year
Rate of correction
Time Frame: One year
Time needed for correction of deformity
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohamed Y. Hassanein, M.Sc., Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMIN000018950

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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