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.: PACTR201709002108128 Date of Approval: 17/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Arthroscopic Quadriceps Tendon Anterior Cruciate Ligament Graft Fixed By Interference Screws Versus Press Fit Technique
Official scientific title Arthroscopic Quadriceps Tendon Anterior Cruciate Ligament Graft Fixed By Interference Screws Versus Press Fit Technique
Brief summary describing the background and objectives of the trial The rate of ACL injuries are increasing overtime and therefore ACL reconstruction is now considered one of the most common procedures in orthopedic surgeries worldwide. Different techniques have been described over the years for ACL reconstructions. Controversies over the graft materials and the method of graft fixation push the surgeons towards further biomechanical and clinical studies aiming at a better outcome of this surgical procedure
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anterior Cruciate Ligament,Injury, Occupational Diseases, Poisoning,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2013
Actual trial start date 02/03/2013
Anticipated date of last follow up 01/06/2015
Actual Last follow-up date 01/10/2015
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Stopped early/ terminated
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 Randomised simple randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Interference Screws 2 years Arthroscopic Quadriceps Tendon Anterior Cruciate Ligament Graft Fixed By Interference Screws 25
Experimental Group Press Fit Technique 2 years Arthroscopic Quadriceps Tendon Anterior Cruciate Ligament Graft Fixed By Press Fit Technique 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with symptomatic isolated torn ACL complaining of instability with or without menisceal injury patients with combined ligamentous injury patients with degenerative changes on pre-operative X ray patients with previous ACL reconstruction 18 Year(s) 42 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 01/01/2016 Beni suef university
Ethics Committee Address
Street address City Postal code Country
MOkbel st. Bani suef 62111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome knee stability,rang of motion 18 monthes
Secondary Outcome Return to pre injury level of activity 18 monthes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bani suef faculty of medicin Mokbel st. Beni suef 62111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Beni suef university Mokbel st. Beni suef 62111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni suef university Mokbel st. Beni suef 62111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
faculty of medicin Mokbel st. Beni suef 62111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator emad elbana elbanaemad@yahoo.com 01224531801 abd el salam aref st.
City Postal code Country Position/Affiliation
bani suef 62111 Egypt
Role Name Email Phone Street address
Public Enquiries atef morsy morsyatef@yahoo.com 01204419600 el horya compound
City Postal code Country Position/Affiliation
bani suef 62111 Egypt
Role Name Email Phone Street address
Scientific Enquiries ahmed mostafa ahmed_91177_gaber@yahoo.com 01063198906 19 port saed st.
City Postal code Country Position/Affiliation
bani suef 62111 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