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.: PACTR202312819351504 Date of Approval: 01/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title How Safe and Technical Is Modified Dunn Osteotomy in the Management of Patients with Slipped Capital Femoral Epiphysis (SCFE): A Clinical Trial with Short-Term Followup
Official scientific title How Safe and Technical Is Modified Dunn Osteotomy in the Management of Patients with Slipped Capital Femoral Epiphysis (SCFE): A Clinical Trial with Short-Term Followup
Brief summary describing the background and objectives of the trial Although pinning in-situ is still the standard and preferred option for the majority of surgeons worldwide in the management of all stages of SCFE, recent trends towards finding the optimum technique and osteotomy to restore anatomical alignment and prevention of deformity have been widely utilized. Several proximal femoral osteotomies have been described at the subcapital, basicervical, intertrochanteric and subtrochanteric levels. The percentage of osteonecrosis reported reached 10% to 100% following various operative approaches, and a combination of osteonecrosis and chondrolysis were reported in up to 42% of the patients This study's rationale was to share our experience in evaluation of the functional and radiological outcomes of modified Dunn osteotomy in management of adolescents with moderate and severe SCFE. This included stable and unstable cases and tries to determine its safety and applicability for routine practice. Primary Objectives:- • Assessment of the clinical outcome of modified Dunn osteotomy in the management of moderate and severe SCFE • Assessment of the radiological outcome of modified Dunn osteotomy in the management of moderate and severe SCFE Secondary Objectives:- • Review the updates on SCFE including different methods of management. • Assessment of iHOT 12 as new simplified tool for scoring clinical outcome of adolescent and adult hips • Reflect on any difference noticed in outcome of patients attending Suez Canal University Hospital
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/02/2017
Actual trial start date 15/02/2017
Anticipated date of last follow up 10/06/2021
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants) 24
Recruitment status Completed
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
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Modified Dunn Osteotomy 1 year followup Safe surgical hip dislocation, originally described by Ganz, preserves the physeal blood supply and allows subcapital osteotomy and complete removal of the posterior callus after peeling off the retinacular flap, complete correction of the slip angle and restoration of the normal anatomy (modified Dunn osteotomy). 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all adolescents with moderate and severe SCFE presented to our hospital, including both stable and unstable cases Previous osteotomy Closure of physis Refusal of participation Unfit for surgery Adolescent: 13 Year-18 Year 12 Year(s) 16 Year(s) Male
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 18/07/2018 Research Ethics Committee Faculty of Medicine Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Ring Road Ismailia Egypt Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The study would add to the literature after achieving its aim through the assessment of modified Dunn osteotomy after surgical hip dislocation in the management of moderate and severe SCFE showing promising results in achieving the optimal functional and radiological outcomes for the patients. preoperative, postoperative at 3, 6 and 12 months
Secondary Outcome Although we came across AVN in 16.7% of cases, all occurring in unstable hips, we believe this complication is due to the primary irreversible vascular insult rather than any technical issue whilst operating. 3, 6 and 12 months postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospital Ring road ismailia 411151 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Authors self funded 24th October Ismailia 411151 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University Ring Road Ismailia 411151 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amro Elsiofy amro_elsiofy@med.suez.edu.eg +447459358854 24th of October
City Postal code Country Position/Affiliation
Ismailia 411151 Egypt Suez Canal University
Role Name Email Phone Street address
Public Enquiries Amro Elsiofy amro_elsiofy@med.suez.edu.eg +447459358854 24th of October
City Postal code Country Position/Affiliation
Ismailia 411151 Egypt Suez Canal University
Role Name Email Phone Street address
Scientific Enquiries Amro Elsiofy amro_elsiofy@med.suez.edu.eg +447459358854 24th of October
City Postal code Country Position/Affiliation
Ismailia Egypt Suez Canal University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I have summarized all Baseline characteristics, study results, Adverse events and Outcome measures in a mastersheet A link to that mastersheet can be accessed through the following link: DOI 10.5281/zenodo.7964134 Clinical Study Report 1 year It is an open access to everyone to review the mastersheet of all the study population
URL Results Available Results Summary Result Posting Date First Journal Publication Date
DOI 10.5281/zenodo.7964134 Yes 19/11/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/11/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information