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.: PACTR201804003315170 Date of Approval: 08/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prevention of Progression Knee Osteoarthritis
Official scientific title Prevention of Progression of Knee Osteoarthritis Using Various Treatment Regimens: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Osteoarthritis is a worldwide common disease. It is a disease of a total joint affecting both cartilage and subchondral bone. There is controversy in the literatures regarding the best treatment for knee osteoarthritis (KOA) because there is a more controversy regarding the initiating factor of this disease. Here we show the results of various treatment regimens for the prevention of progression of KOA. Five groups of 50 patients with early KOA were treated with five treatment regimens using a parallel-group randomized controlled trial (RCT) design. Group 1 (control) received analgesics as needed for one year. Group 2 received nonsteroidal anti-inflammatory drugs (NSAID) plus physiotherapy for one month; with analgesics as needed for the rest of the year. Group 3 received NSAID plus physiotherapy, plus vasoprotective and vasoactive drugs for one month; vasoprotective and vasoactive drugs for the next five months, and analgesics as needed for the rest of the year. Group 4 received NSAID plus physiotherapy, plus a bisphosphonate for one month; bisphosphonate drug for the next five months; and analgesics as needed for the rest of the year. Group 5 received NSAID plus physical therapy, plus vasoprotective and vasoactive drugs; plus a bisphosphonate drug for one month; vasoprotective and vasoactive drugs plus a bisphosphonate drug for the next five months; and analgesics as needed for the rest of the year. Results showed that progression of KOA in groups 1 through 5 were 66%, 55%, 24%, 25%, and 14% of patients, respectively. This work shows that the most effective treatment modalities were antiresorptive drugs and vascular drugs.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Osteoarthritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/03/2011
Actual trial start date 01/03/2011
Anticipated date of last follow up 28/02/2014
Actual Last follow-up date 28/02/2014
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants) 250
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
# UHCT 537-2-2010. Ministry Of Health, Egypt
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 Randomization: Following eligibility screening by the research coordinator, we apply the random allocation rule by the restricted shuffled approach, which involves identifying the sample size (250), apportioning a number (50) of specially prepared cards for each treatment according to the allocation ratio (1:1:1:1:1 ratio), inserting the cards into envelopes, and shuffling them to produce a form of random assignment without replacement. Research coordinators, attending care teams, patients, and study assessors (radiographical and laboratory) were blinded to treatment allocation. Sealed opaque envelope Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group 1 received analgesics (Acetaminophen with a maximum of doses of 3 g per day) as needed for one year one year received analgesics (Acetaminophen with a maximum of doses of 3 g per day) as needed for one year 50 Active-Treatment of Control Group
Experimental Group group 2 non steroidal anti-inflammatory drugs (a COX-2 inhibitor selective NSAID, celecoxcib) plus physiotherapy (19) for one month and home exercises for another month; with analgesics (Acetaminophen) as nee one year non steroidal anti-inflammatory drugs (a COX-2 inhibitor selective NSAID, celecoxcib) plus physiotherapy (19) for one month and home exercises for another month; with analgesics (Acetaminophen) as needed for the rest of the year. 50
Experimental Group group 3 NSAID plus physiotherapy and home exercises, plus vasoprotective drug (Micronized diosmin 450mg & hesperidin 50mg/tablet; 2 tablets/day) and vasoactive drug (pentoxifylline 400 mg/tablets twice daily one year NSAID plus physiotherapy and home exercises, plus vasoprotective drug (Micronized diosmin 450mg & hesperidin 50mg/tablet; 2 tablets/day) and vasoactive drug (pentoxifylline 400 mg/tablets twice daily after meals ) for one month; vasoprotective and vasoactive drugs for the next five months, and analgesics as needed for the rest of the year. 50
Experimental Group group 4 NSAID plus physiotherapy and home exercises, plus a bisphosphonate drug (risedronate 35 mg weekly) for one month, a bisphosphonate drug for the next five months; and analgesics as needed for the rest one year NSAID plus physiotherapy and home exercises, plus a bisphosphonate drug (risedronate 35 mg weekly) for one month, a bisphosphonate drug for the next five months; and analgesics as needed for the rest of the year 50
Experimental Group group 5 NSAID drug plus physiotherapy and home exercises, plus vasoprotective and vasoactive drugs; plus a bisphosphonate drug for one month; vasoprotective and vasoactive drugs plus a bisphosphonate drug fo one year NSAID drug plus physiotherapy and home exercises, plus vasoprotective and vasoactive drugs; plus a bisphosphonate drug for one month; vasoprotective and vasoactive drugs plus a bisphosphonate drug for the next five months; and analgesics as needed for the rest of the year. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-symptomatic and radiographic diagnostic criteria of early knee OA -age 45-55 years -Body mass index less than 30. -Patients with causes of secondary KOA (e.g. rheumatoid, gouty, traumatic soft tissues and bony injuries, mechanical malalignment with varus > 10 degrees and valgus > 15 after obtaining full limb radiograghs, etc.) -a history of knee surgery -intra-articular injection -use of antiresorptive drugs within the 12 months preceding enrollment. 45 Year(s) 55 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 05/12/2010 Institutional Review Board, Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
2, Yasen Abdelghafar Street Shbin Elkom, Menoufia 3800 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The outcome instrument for evaluation of treatment regimen efficacy on symptoms of OA was the Western Ontario and McMaster Universities (WOMAC) OA index one year
Primary Outcome The visual analog scale (VAS) one year
Primary Outcome Radiographical evaluation included 1.5 T MRI one year
Primary Outcome measurement of urinary levels of the N-terminal crosslinking telopeptide of type I collagen one year
Primary Outcome measurement of urinary levels of C-terminal crosslinking telopeptide of type II collagen one year
Secondary Outcome Return to level of activity that was prior to symptoms of disease (Osteoarthritis). one year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Hospitals, Faculty of Medicine 2 , Yasen Abdelghafar Street shbin Elkom,Menoufia 4800 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 2, Yasen Abdelghafa Street Shbin Elkom, Menoufia 4800 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 2 , Yasen Abdelghafar Street Shbin Elkom, Menoufia 4800 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faculty of Medicine 2 , Yasen Abdelghafar Street Shbin Elkom, Menoufia 4800 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elsayed Morsi dr.elsayedmorsi@gmail.com 00201227469041 58, Port Saeed Street, Camp Chizar
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt Professor of Orthopedic Surgery, Faculty of Medicine, Menoufia University
Role Name Email Phone Street address
Public Enquiries Elsayed Morsi dr.elsayedmorsi@gmail.com 00201227469041 58, Port Saeed Street, Camp chizar
City Postal code Country Position/Affiliation
Alexandria 2111 Egypt Professor of Orthopedic Surgery, Faculty of Medicine, Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Elsayed Morsi dr.elsayedmorsi@gmail.com 00201227469041 58, Port Saeed Street, Camp Chizar
City Postal code Country Position/Affiliation
Alexandria 2111 Egypt Professor of Orthopedic Surgery, Faculty of Medicine, Menoufia University
REPORTING
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