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.: PACTR201804003237309 Date of Approval: 21/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Acute Quadriceps Tendon Rupture: outcome of early mobilisation after suture anchor versus end-to-end repair with wire reinforcement in 12 patients
Official scientific title Acute Quadriceps Tendon Rupture: outcome of early mobilisation after suture anchor versus end-to-end repair with wire reinforcement in 12 patients
Brief summary describing the background and objectives of the trial Acute Quadriceps Tendon Rupture: outcome of early mobilisation after suture anchor versus end-to-end repair with wire reinforcement in 12 patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,sports related trauma,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 02/08/2012
Actual trial start date 02/08/2012
Anticipated date of last follow up 30/09/2016
Actual Last follow-up date 30/09/2016
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 12
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised consecutive simple randomisation Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group anchor suture repair surgical intervention 6
Control Group end to end repair with cerclage reinforcement 6 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Failure of active knee extension radiological evidence of complete Quadriceps tendon rupture history of recent trauma < 7 days Neglected or chronic ruptures history of previous failed repair patella fractures or associated fractures of the ipsilateral limb 25 Year(s) 48 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 13/05/2015 Commitee Scientifique et recherche clinique,CHU Hassan II
Ethics Committee Address
Street address City Postal code Country
Avenue Hrazeem,BP atlas Fes 30000 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Active flexion 2 weeks 4wks 6weeks 8weeks 10 weeks 12 weeks 14 weeks 16 weeks 6months 8months 10months 12months 24months 36months 48months
Secondary Outcome lysholm rating 12months 24months 36months 48months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
centre hospitalier universitaire Hassan II Avenue Hrazeem Fes 30000 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
Not applicable
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty de Medicine et de Pharmacie,Université Sidi Mohamed BenAbdellah Avenue Hrazeem Fes 30000 Morocco University
COLLABORATORS
Name Street address City Postal code Country
Department of Public Health and Scientific Research,Sidi Mohamed BenAbdellah University Avenue Hrazeem Fes 30000 Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amine Marzouki doc.marzouki@hotmail.com 00212661261022 Avenue Hrazeem
City Postal code Country Position/Affiliation
Fes 30000 Morocco Consultant Department of Trauma and Orthopedic Surgery
Role Name Email Phone Street address
Public Enquiries Abdulrazak Saeed saeed.abdulrazzak95@gmail.com +212660417317 Avenue Hrazeem
City Postal code Country Position/Affiliation
fes 30000 Morocco Resident
Role Name Email Phone Street address
Scientific Enquiries Boutayeb Fawzi boutayeb_fawzi@yahoo.fr +212661480022 Avenue Hrazeem
City Postal code Country Position/Affiliation
Fes 30000 Morocco Registrar
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