Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000195358
Ethics application status
Approved
Date submitted
10/04/2008
Date registered
14/04/2008
Date last updated
14/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intra-articular Sodium Hyaluronate Injection after Arthroscopic Débridement for Osteoarthritis of the Knee: A Prospective, Randomized, Controlled Study
Scientific title
The effects of intra-articular Sodium Hyaluronate Injection after Arthroscopic Débridement for Osteoarthritis of the Knee evaluated by pain and physical scales: A Prospective, Randomized, Controlled Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 3027 0
Condition category
Condition code
Musculoskeletal 3180 3180 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment course consisted of a continued series of three intra-articular injections of sodium hyaluronate (Orthovisc) administered during 3 consecutive weeks starting 3-weeks postoperatively (40 patients) into the affected (arthroscopied) knee joint. The HA used in this study was Orthovisc®, (30 mg sodium hyaluronate dissolved in 2 ml physiological saline; Anika Therapeutics Inc., Woburn, MA, USA).
Intervention code [1] 2788 0
Treatment: Drugs
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 4068 0
the pain function subscales of the Western Ontario MacMaster (WOMAC) OA Index
Timepoint [1] 4068 0
24 weeks after arthroscopic debridement.
Secondary outcome [1] 6843 0
the physical function subscales of the Western Ontario MacMaster (WOMAC) OA Index
Timepoint [1] 6843 0
6, 12 weeks after arthroscopic debridement.

Eligibility
Key inclusion criteria
age between 40-65 years, symptomatic primary knee OA according to American College of Rheumatology criteria with a Kellgren-Lawrence (K-L) severity grade of level II or III as determined radiographically at screening.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who refused to provide the written informed consent for taking part in the study, agreed to follow study procedures and attend all study visits.
• Patients with previously known bleeding diathesis or coagulation disorder,
• Patients who have any form of contraindication for an arthroscopy procedure,
• Patients with known allergies against chicken or chicken products for intra-articular sodium hyaluronate injection,
• Patients with secondary arthritis, like rheumatoid arthritis or suspected to have any other form of an inflammatory arthritis,
• Patients in whom “microfracture” technique was used during AD,
• Patients with major frontal plane deformities,
• Patients with patellar disorder or quadriceps mechanism disorders,
• Patients with advanced level of mental handicap preventing them from fulfilling the study requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 885 0
Turkey
State/province [1] 885 0

Funding & Sponsors
Funding source category [1] 3283 0
Other
Name [1] 3283 0
Nurettin Heybeli
Country [1] 3283 0
Turkey
Primary sponsor type
University
Name
Hacettepe University
Address
Department of orthopaedics and Traumatology, Hacettepe University School of medicine
Country
Turkey
Secondary sponsor category [1] 2938 0
None
Name [1] 2938 0
Address [1] 2938 0
Country [1] 2938 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28514 0
Address 28514 0
Country 28514 0
Phone 28514 0
Fax 28514 0
Email 28514 0
Contact person for public queries
Name 11671 0
Nurettin Heybeli
Address 11671 0
Sadik Ahmet cd Taninmislar 2000 Sitesi A Blok D:2 22030 Edirne
Country 11671 0
Turkey
Phone 11671 0
00905322861446
Fax 11671 0
00902842353941
Email 11671 0
[email protected]
Contact person for scientific queries
Name 2599 0
Nurettin Heybeli
Address 2599 0
Sadik Ahmet cd Taninmislar 2000 Sitesi A Blok D:2 22030 Edirne
Country 2599 0
Turkey
Phone 2599 0
00905322861446
Fax 2599 0
00902842353941
Email 2599 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.