NCT03689959

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

4.3 years

First QC Date

September 27, 2018

Last Update Submit

July 18, 2023

Conditions

Knee Deformity

Keywords

kneeflexion deformityhemiepiphysiodesiseight platechildren

Outcome Measures

Primary Outcomes (1)

  • Degree of flexion deformity

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

    One year

Secondary Outcomes (2)

  • Complications

    One year

  • Rate of correction

    One year

Study Arms (1)

Patients

EXPERIMENTAL

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

Interventions

Eight plate hemiepiphysiodesisPROCEDURE

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.

Also known as: Guided growth
Patients

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Fixed knee flexion deformity more than 10°
  • Unilateral or bilateral cases
  • months or more predicted growth remaining
  • No response to non-operative treatment (physical therapy, bracing, casting);
  • Recurrent cases

You may not qualify if:

  • Dynamic deformities due to spasticity
  • Deformities responding to conservative treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71111, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 22307752BACKGROUND

  • 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.

    PMID: 18724198RESULT

  • 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.

    PMID: 21102213RESULT

  • 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.

    PMID: 6511897RESULT

  • 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.

    PMID: 25075896RESULT

  • 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.

    PMID: 18427750RESULT

Study Officials

  • Mohamed Y. Hassanein, M.Sc.

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 1, 2018

Study Start

November 1, 2018

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

EG(1)