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.: PACTR201702001930102 Date of Registration: 23/12/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study between arthroscopic suturing versus open reduction and internal fixation in PCL tibial avulsion fracture
Official scientific title PCL management
Brief summary describing the background and objectives of the trial An avulsion fracture of the posterior cruciate ligament (PCL) from its tibial insertion is a rare injury in the Western world. In comparison, its incidence is much higher in countries such as India, China and because of the more frequent motorbike related injuries. According to current literature, early surgical treatment of displaced bony avulsion of the PCL is regarded as necessary to restore knee stability. However, the optimal surgical treatment for isolated tibial avulsion fractures of the PCL has caused considerable controversy. Several operative techniques have been described and recommended. Open reduction with internal fixation through a posterior approach has been reported and indicated as suitable for the achievement of stability. Given the deep location of the PCL and the complexity of the anatomy, minimally invasive approaches including microendoscopy-assisted and arthroscopic techniques have been developed. Despite good clinical results with open refixation of the bony avulsion, there is no general agreement regarding either the approach or the optimal fixation technique, even though biomechanical studies have shown comparable results
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied management of posterior cruciate ligament tibial avulsion fracture,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2016
Actual trial start date 01/04/2016
Anticipated date of last follow up 28/02/2017
Actual Last follow-up date 01/03/2017
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Recruiting
Publication URL Comparative study between arthroscopic suturing versus open reduction and internal fixation in PCL tibial avulsion fracture
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 Randomised Simple randomisation using a randomisation table from a statistics book Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group arthroscopic suturing 2 hours arthroscopic suturing 10
Experimental Group open fixation of PCL tibial avulsion fractures 1 hour open fixation of PCL tibial avulsion fractures 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. Inclusion criteria: 1- Patient with displaced PCL tibial avulsion fracture >2 mm 2- Patients with isolated PCL avulsion 3- Patients with acute PCL avulsion less than 6 weeks b. Exclusion criteria: 1-Associated ligamentus injury 2-Old PCL avulsion more than 6 weeks 3-presence of joint arthritis 4-presence of joint infection 20 Year(s) 50 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
No 13/12/2017 ethics committee of faculty of medicine ,assiut university
Ethics Committee Address
Street address City Postal code Country
assiut university, faculty of medicine , ethics committe assiut Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome better technique favorable result
Secondary Outcome economic results cheapest
Secondary Outcome time outcome shortest
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
assiut university hospitals assiut university hospitals , assiut 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
orthopedic department assiut university hospitals , assiut 71515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor orthopedic department assiut university hospitals , assiut 71515 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
mohamed abd el radi assiut university hospitals , assiut 71515 Egypt
ayman farouk assiut university hospitals, orthopedic department assiut 71515 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hisham Abdelraheem Elkady Mohamed Mohamed Abdelhamid Morsy Hishamkady@hotmail.com 01005211797 assiut university orthopedic department
City Postal code Country Position/Affiliation
assiut Egypt
Role Name Email Phone Street address
Public Enquiries Mohamed Mohamed Abdelhamid Morsy m.abdelhamid68@gmail.com 01111230095 assiut university orthopedic department
City Postal code Country Position/Affiliation
assiut Egypt
Role Name Email Phone Street address
Scientific Enquiries Islam Kramallah Ramadan I_karam@yahoo.com 01222213247 assiut university orthopedic department
City Postal code Country Position/Affiliation
assiut Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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