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

NCT ID: NCT03689959

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2023-03-01

Brief Summary

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

Detailed Description

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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 ?

Conditions

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Knee Deformity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Eight plate hemiepiphysiodesis

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Guided growth

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Yahya Abdel Azeem Hassanein

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Y. Hassanein, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 22307752 (View on PubMed)

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.

Reference Type RESULT
PMID: 18724198 (View on PubMed)

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.

Reference Type RESULT
PMID: 21102213 (View on PubMed)

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.

Reference Type RESULT
PMID: 6511897 (View on PubMed)

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.

Reference Type RESULT
PMID: 25075896 (View on PubMed)

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.

Reference Type RESULT
PMID: 18427750 (View on PubMed)

Other Identifiers

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UMIN000018950

Identifier Type: -

Identifier Source: org_study_id

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