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.: PACTR201403000801118 Date of Approval: 27/03/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Articular cartilage changes following meniscectomy
Official scientific title Evaluation of early changes of cartilage biomarkers following arthroscopic partial meniscectomy in young adults
Brief summary describing the background and objectives of the trial The metabolic imbalance in the articular cartilage following meniscectomy includes both an increase in cartilage degradation and an insufficient reparative or anabolic response resulting in structural, biochemical and mechanical changes. Remarkably, cartilage affected by trauma or disease can progress from pre-clinical, to pre-radiographic, to radiographic damage. Considerable changes occur before the development of the first radiographic abnormalities; for example, >10% of knee cartilage volume is lost and a >40% prevalence of knee cartilage defects is observed by the time the earliest radiographic changes are present. Objective: to evaluate combinations of imaging and biochemical biomarkers for cartilage breakdown, synthesis and quantity in the early period postarthroscopic meniscectomy. Such combinations may yield complementary information from the individual markers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,post-arthroscopic meniscectomy,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/01/2013
Actual trial start date 01/03/2013
Anticipated date of last follow up 31/01/2014
Actual Last follow-up date 31/01/2014
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size =4) and the block size was not variable Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Imaging and Biochemical analysis imaging twice, Biochemical analysis trice imaging 6 months apart, biochemical analysis 3 months apart Diagnostic & prognostic 20
Control Group Imaging and Biochemical analysis imaging one, Biochemical analysis once 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
young adults who underwent unilateral arthroscopic partial meniscectomy with stable knees. General criteria for exclusion from the study will be as follows: - Age older than 50 years at the time of evaluation (to exclude idiopathic osteoarthritis according to the ACR criteria). -The presence of inflammatory arthritides. -Surgery at any joint before. -Diabetes mellitus. -Varicose veins of the lower limbs. - Neurological or muscular disease (because these comorbid conditions will affect the patient relevant outcome). - Any contraindication to MRI examination. Knee- specific criteria for exclusion (either knee) will be: Previous knee surgery (other than meniscus surgery). Osteochondritis dissecans. Osteochondromatosis. Fracture in or adjacent to the knee. Septic arthritis. Osteonecrosis. Chondromalacia patellae. Patellar subluxation. Radiographic changes indicating knee OA at the time of index surgery. 22 Year(s) 39 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 01/01/2013 Ethical Committe of Alexandria University
Ethics Committee Address
Street address City Postal code Country
Shamblion street, el azareeta Alexandria Egypt
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 03/11/2011 Ethical Committe of Alexandria University
Ethics Committee Address
Street address City Postal code Country
Shamblion street, el azareeta Alexandria Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cartilage breakdown, synthesis and quantity Preoperative , three and six months postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Physical Medicine, Rheumatology and Rehabilitation, Faculty of Medicine, University of Alexandria. Shamblion street, el azareeta Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Physical Medicine, Rheumatology and Rehabilitation, Faculty of Medicine, University of Alexandria. Shamblion street, el azareeta Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Physical Medicine, Rheumatology and Rehabilitation, Faculty of Medicine, University of Alexandria. Shamblion street, el azareeta Alexandria Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hamdy Khamis Koryem, Shamblion street, el azareeta Alexandria Egypt
Mohamed Adel Abd El Qawy Wanas, Shamblion street, el azareeta Alexandria Egypt
Hesham Taha Kotb Shamblion street, el azareeta Alexandria Egypt
Mohamed Mahmmoud Abdel Hamid El Shafei, Shamblion street, el azareeta Alexandria Egypt
Abir Hassan Naguib, Shamblion street, el azareeta Alexandria Egypt
Hoda Mohammed Aly Abd El Naby Shamblion street, el azareeta Alexandria Egypt
Mohamed Mostafa Ahmed Rizk, Shamblion street, el azareeta Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hoda Abdel Naby Hoda_naby@yahoo.com 002017380883 277 el geish street , stanly
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Lecturer of Physical Medicine, Rheumatology and Rehabilitation
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient information Manager
Role Name Email Phone Street address
Scientific Enquiries Hoda Abdel Naby Hoda_naby@yahoo.com 002017380883 277 el geish street , stanly
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Lecturer of Physical Medicine, Rheumatology and Rehabilitation
REPORTING
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