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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202204468763535 Date of Registration: 06/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessment of Modified Kocher-Langenbeck Surgical Approach Compared with Conventional Kocher-Langenbeck Surgical Approach in Treatment of Simple Posterior Wall Acetabular Fractures
Official scientific title Assessment of Modified Kocher-Langenbeck Surgical Approach Compared with Conventional Kocher-Langenbeck Surgical Approach in Treatment of Simple Posterior Wall Acetabular Fractures
Brief summary describing the background and objectives of the trial Displaced fractures of the acetabulum are best treated with anatomic reduction and rigid internal fixation. The Kocher–Langenbeck approach is the most commonly used surgical exposure for the stabilization of displaced posterior wall fractures of the acetabulum. Varying results have been reported by different authors by using posterior and extensile approaches. Complications include iatrogenic nerve palsies, wound infections, deep vein thrombosis/pulmonary embolism avascular necrosis of the femoral head, heterotopic ossification and posttraumatic osteoarthritis of the hip. The conventional surgical exposure by the Kocher–Langenbeck approach involves the division of short rotators of the hip while the modified Kocher–Langenbeck surgical approach provide a posterior surgical technique with preservation of short rotators of hip. In this study we will compare between the modified Kocher-Langenbeck surgical approach and the conventional Kocher–Langenbeck surgical approach to reach a suitable surgical technique in treatment of simple fractures of posterior wall of acetabulum with less complication and maintain the anatomical stability of hip joint
Type of trial RCT
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 10/06/2019
Actual trial start date 23/07/2019
Anticipated date of last follow up 23/07/2021
Actual Last follow-up date 01/10/2021
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 36
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Orthopedic Surgical approach 1 year Modified Kocher-Langenbeck minimal invasive posterior acetabular approach with sparing of hip lateral rotators 18
Control Group Orthopedic Surgical approach 1 year Conventional Kocher-Langenbek acetabular surgical approach 18 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who have acetabular fractures and indicated for posterior acetabular fixation are : 1) Adult age group (18-60 year old). 2) Both sexes. 3) Simple displaces fractures of posterior wall of acetabulum 1) Marginal impacted fractures. 2) Multi-fragmented fractures. 3) Open fractures. 4) Other types of posterior acetabular fractures (eg, posterior column, posterior wall and column). 5) Superior acetabular region. 6) Fracture high in greater sciatic notch. 7) Medical contra-indications. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 03/10/2021 research ethics committee of faculty of medicine at Suez Canal university
Ethics Committee Address
Street address City Postal code Country
Ring road 4.5 km Ismailia 41111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Radiological and functional 1 year
Secondary Outcome Complications and surgery time 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal university hospitals Ring road 4.5 km Ismailia 41111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Suez Canal university 4.5 km Ring road Ismailia 41111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Suez Canal university Ring road 4.5 km Ismailia 41111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Atef Mahmoudatef@med.suez.edu.eg +201008765710 58 Salah Salem St., Ismailia 1
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Lecturer of orthopedic surgery at faculty of medicine Suez Canal university
Role Name Email Phone Street address
Public Enquiries Ayman Henawy Ayman_henawy@med.suez.edu.eg +201222773034 42 shbeen St., Ismailia 2
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Assistant professor of orthopedic surgery at faculty of medicine Suez Canal university
Role Name Email Phone Street address
Principal Investigator Mohamed Mahmoud MohamedGamal@med.suez.edu.eg +201274877337 3 main St. Port Fouad
City Postal code Country Position/Affiliation
Port Said 42523 Egypt Orthopedic surgery resident at Suez Canal authority hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available that underline the results reported in this article after deidentification (text, tables, figures and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years This is a randomized control trial study conducted to assess the outcome of posterior acetabular approaches for fixation of posterior wall acetabular fractures for anyone who wishes to access the data with analysis of data for any purpose by (SPSS) for Windows programe version 22.0 and excel software for windows
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information