Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis
Primary Purpose
Knee Deformity
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Eight plate hemiepiphysiodesis
Sponsored by
About this trial
This is an interventional treatment trial for Knee Deformity focused on measuring knee, flexion deformity, hemiepiphysiodesis, eight plate, children
Eligibility Criteria
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
Sites / Locations
- Assiut University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
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
Outcomes
Primary Outcome Measures
Degree of flexion deformity
The angle between the anterior borders of thigh and leg measured clinically with a goniometer
Secondary Outcome Measures
Complications
Wound complications, metal failure
Rate of correction
Time needed for correction of deformity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03689959
Brief Title
Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis
Official Title
Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 ?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Deformity
Keywords
knee, flexion deformity, hemiepiphysiodesis, eight plate, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Eight plate hemiepiphysiodesis
Other Intervention Name(s)
Guided growth
Intervention Description
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.
Primary Outcome Measure Information:
Title
Degree of flexion deformity
Description
The angle between the anterior borders of thigh and leg measured clinically with a goniometer
Time Frame
One year
Secondary Outcome Measure Information:
Title
Complications
Description
Wound complications, metal failure
Time Frame
One year
Title
Rate of correction
Description
Time needed for correction of deformity
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Y. Hassanein, M.Sc.
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
22307752
Citation
Spiro AS, Stenger P, Hoffmann M, Vettorazzi E, Babin K, Lipovac S, Kolb JP, Novo de Oliveira A, Rueger JM, Stuecker R. Treatment of fixed knee flexion deformity by anterior distal femoral stapling. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2413-8. doi: 10.1007/s00167-012-1915-8. Epub 2012 Feb 4.
Results Reference
background
PubMed Identifier
18724198
Citation
Klatt J, Stevens PM. Guided growth for fixed knee flexion deformity. J Pediatr Orthop. 2008 Sep;28(6):626-31. doi: 10.1097/BPO.0b013e318183d573.
Results Reference
result
PubMed Identifier
21102213
Citation
Spiro AS, Babin K, Lipovac S, Rupprecht M, Meenen NM, Rueger JM, Stuecker R. Anterior femoral epiphysiodesis for the treatment of fixed knee flexion deformity in spina bifida patients. J Pediatr Orthop. 2010 Dec;30(8):858-62. doi: 10.1097/BPO.0b013e3181f10297.
Results Reference
result
PubMed Identifier
6511897
Citation
Heydarian K, Akbarnia BA, Jabalameli M, Tabador K. Posterior capsulotomy for the treatment of severe flexion contractures of the knee. J Pediatr Orthop. 1984 Nov;4(6):700-4. doi: 10.1097/01241398-198411000-00009.
Results Reference
result
PubMed Identifier
25075896
Citation
Inan M, Sarikaya IA, Yildirim E, Guven MF. Neurological complications after supracondylar femoral osteotomy in cerebral palsy. J Pediatr Orthop. 2015 Apr-May;35(3):290-5. doi: 10.1097/BPO.0000000000000264.
Results Reference
result
PubMed Identifier
18427750
Citation
Carbonell PG, Valero JV, Fernandez PD, Vicente-Franqueira JR. Monolateral external fixation for the progressive correction of neurological spastic knee flexion contracture in children. Strategies Trauma Limb Reconstr. 2007 Dec;2(2-3):91-7. doi: 10.1007/s11751-007-0026-4. Epub 2007 Dec 4.
Results Reference
result
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Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis
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