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.: PACTR201702002036337 Date of Approval: 13/02/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Less invasive approaches in anterior associated types of acetabular fractures
Official scientific title Less invasive approaches in anterior associated types of acetabular fractures
Brief summary describing the background and objectives of the trial Acetabular fractures are severe injuries, most frequently caused by a high-energy trauma. Fractures of the extremities, head injuries, chest, abdomen and pelvic ring injuries are the most commonly associated injuries [1]. Acetabular fractures are relatively uncommon injuries. Within approximate annual incidence of 3 cases per 100,000 inhabitants, they constitute 0.3-6% of all fractures. They are usually seen in the context of multiple trauma patients, the most common cause of which is traffic accidents. Management of acetabular fractures remains a challenge for orthopedic surgeons [11]. The treatment options for acetabular fractures range from non-operative treatment for un-displaced fractures to operative fixation with extensile approaches [10,12]. Judet and Letournel were pioneers in the surgical treatment of displaced acetabular fractures [13, 14]. Open anatomical reduction of the articular surface in displaced acetabular fractures, rigid internal fixation and early mobilization has become a standard treatment for these injuries [15, 16]. The ilioinguinal approach allows direct access to the anterior column, Modifications have been developed to broaden traditional approaches to the acetabulum and mitigate complications. An understanding of the advantages and limitations of each echnique can enable surgeons to choose the proper exposure for anatomic reduction and fracture fixation. Less invasive approaches as modified stoppa , pararectus and minipararectus
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied approaches for acetabular fractures,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2016
Actual trial start date 01/01/2016
Anticipated date of last follow up 01/02/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ethics committees at assiut university
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)
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not 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
Control Group moddified stoppa 15 1 year moddified stoppa approaches 15 Active-Treatment of Control Group
Experimental Group pararectus 15 1year pararectus approach 15
Experimental Group minipararectus 10 1 year minipararectus approach 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-all skeletally mature patients(above 18 years old) 2-patients with anterior associated types of acetabular fractures(T shape ,associated both column and anterior with posterior transverse) 3-closed fractures 1-all skeletally immature patients(below 18 years old) 2-anterior wall and column acetabulum fractures and posterior actabular fractures 3-open fractures 18 Year(s) 65 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 28/02/2017 facult of medicine assuit university ethics committee
Ethics Committee Address
Street address City Postal code Country
university street -facult of medicine -assiut assiut 7111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduction of fractures assessment of redaction by matta scores Anatomical 0-1mm displacement Imperfect 2-3mm Poor >3mm
Secondary Outcome assessment function of patient Harris hip scores Excellent result: 90-100 points Good result: 80-89 points Average earnings: 70-79 points Bad result : <70 points
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
orthopadic department assiut university hospital university street-assiut assuit 7111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine assiut university university street-assiut assuit 7111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine assiut university university street-assiut assuit 7111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ali fergany abd el rhaim orthopadic department assuit university hospital street-assiut assuit 7111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faisal Fahmy Adam Adam_ffa@yahoo.com 01021216968 orthopadic department assiut university hospital
City Postal code Country Position/Affiliation
assuit 7111 Egypt head of department
Role Name Email Phone Street address
Public Enquiries Osama Ahmed Farouk osama_farouk@yahoo.com 01222443531 orthopadic department assiut university hospital
City Postal code Country Position/Affiliation
assuit 7111 Egypt Director of the Central Administration for assiut university hospitals
Role Name Email Phone Street address
Scientific Enquiries Aly mohamadean Wegaly1999@yahoo.com 01223460704 orthopadic department assiut university hospital
City Postal code Country Position/Affiliation
assuit 7111 Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information