Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201705002240283 Date of Approval: 28/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Surgical treatment of posttraumatic physeal injury around the knee in children
Official scientific title Surgical treatment of posttraumatic physeal injury around the knee in children
Brief summary describing the background and objectives of the trial Posttraumatic Physeal injuries around the knee are a quite common injury in children. It represents approximately 5 % of growth plate injuries. Approximately 80% of physeal injuries will occur between the ages of 10 and 16 years, with a median age of 13 years. Salter and Harris described a classification for physeal injuries based on radiographic findings. The system predicts the prognosis for any given injury and guides treatment choice. Physeal growth arrest in the knee region results in malalignment in lower limb axis and length discrepancy problems. The pediatric skeleton differs from that of an adult in that the bones are more elastic and they contain growth plates (physes). A basic understanding of the anatomy and physiology of the physis is mandatory in order that injuries to the growth plate can be managed effectively Different Modalities of treatment exist such as corrective osteotomies, epiphysiodesis, ilizarov external fixator and phseal bar excision .Choosing the appropriate modality of intervention is challenged by many factor according to age, potentiality of the physis to grow, severity of deformity.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) cohort
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Paediatrics,posttraumatic physeal injury around the knee,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/05/2017
Actual trial start date 01/05/2017
Anticipated date of last follow up 30/04/2020
Actual Last follow-up date 30/04/2020
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group physeal bar excision once 1 year Bar excision when less than 50% of thephysis is involved and when at least 2.5 cm of growth remains. Simultaneous corrective osteotomy should be performed when the angular deformity exceeds 20 degrees 5
Experimental Group Epiphysiodesis 0nce till correction of deformity or limb lenght dicrepancy Epiphysiodesis is indicated for contralteral side in mild to moderate LLD (2¿5 cm), actual or predicted leg length discrepancy in a skeletally immature child with adequate growth remaining and an acceptable final height at skeletal maturity 10
Experimental Group Ilizarov external fixator once till correction of deformity or limb lenght discrepancy Ilizarov external fixator is indicated for correction of sever deformity with the risk of neurovascular insult if done acute and also for gradual lengthening of limb length discrepancy if present after correction of the deformity by osteotomy or epiphysiodesis 5
Experimental Group corrective osteotomy once acute correction of deformity corrective osteotomy should be performed when the angular deformity exceeds 20 degrees and no the risk of neurovascular insult if done acute 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Chronic physeal injury in distal femur and proximal tibia at least after 6 weeks of trauma. Age up to 16 Patients operated by Osteotomies,epiphysiodesis, ilizarov external fixator and phseal bar excision . Written consent, free and informed Acute physeal injury less than 6 weeks Above the age of 16 Epiphyseal dysplasia Associated ligamentous injury physeal abrasion injury with sever soft tissue loss Unfit 1 Year(s) 16 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/04/2017 assiut university faculty of medicine ethics committee
Ethics Committee Address
Street address City Postal code Country
assuit university faculty of medicine assiut 17511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of cases scored excellent on follow up visits using Knee Society Score (KSS) and Lysholm Knee Scoring Scale 2 weeks 3 months 6 months 9 months 1 year
Secondary Outcome Alignment of mechanical and anatomical axes of the knee 3 months 6 months 9 months 1 year
Secondary Outcome limb length discrepancy 1 day 3 months 6 months 9 months 1 year
Secondary Outcome bone union after correction 6 weeks 3 months 6 months 9 months 1 year
Secondary Outcome detection of physeal bar recurrence 3 months 6 months 9 months 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut university hospital orthopedic departmentpediatric unit Asiuit university hospital Assiut 17511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor assiut university hospital assiut university hospital assiut 17511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abdel-Khalek Hafez Ibrahim Assiut university hospital Orthopedics & Traumatology Department Assiut 17511
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdel-Khalek Ibrahim Ortho2015@yahoo.com 01222302088 assiut university hospital Orthopedics Department
City Postal code Country Position/Affiliation
assiut 71511 Egypt emirtus professror
Role Name Email Phone Street address
Public Enquiries Nariman Abol Oyoun Aboloyoun@yahoo.com 02 01222302343 assiut university hospital Orthopedics Department
City Postal code Country Position/Affiliation
assiut 71511 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Mohamed Hassan mohammedkhaledortho@gmail.com 02 01026161155 assiut university hospital Orthopedics Department
City Postal code Country Position/Affiliation
assiut 71511 Egypt lecturer
REPORTING
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