- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03913052
Intra-articular Viscosupplement Application in Knee Osteoarthritis
A Research on The Effects of Intra-articular Viscosupplement Application Containing Hyaluronic Acid, Chondroitin Sulfate and Glucosamine Compounds on the Isokinetic Muscle Test Values of Patients With 40-65 Years of Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Knee osteoarthritis (OA) is one of the common diseases which causes pain and disability with increasing age. In developed countries, it is said to be one of the ten diseases which decreases functionality most. With a prevalence between 22% - 39%, 7% of which are patients who are over 65 years old, and when examined world-wide, it is stated that knee OA is seen 18% of women and 9,6% of men. Knee OA is characterized by pain, and; functional loss and progressive mobility where motions are required a physical activity of lower extremity. The disease causes 80% of restriction of motions and 25% of restriction of daily life activities. Additionally, along with the loss of proprioception, it can be seen defects of static and dynamic postural stability and the loss of balance. The factors of disease cause reduced muscle strength, defects of functionality of muscles and reduced workout capacity. According to the radiographic classification of Kellgren and Lawrence, quadriceps muscle weakness is frequently seen without atrophy and pain in early phases of knee OA of which degree is 0 or 1. If the symptoms are accompanied by a knee pain, the weakness of muscles will show an increase more and cause dysfunction and progression of disease. An increase of force in the muscles of quadriceps and hamstring plays a positive role for stability and mobility of joints and pain tolerance.
In the literature, studies with intra-articular HA injection in the treatment of knee OA are frequently seen, but the number of studies about the co-injection of HA, CS and GA is scarcely any. At the same time, studies investigating the effect of intra-articular viscosupplementation injection on isokinetic muscle strength was not observed. Therefore, the investigators aimed at investigating the effects of HA, CS and GA injection on isokinetic quadriceps and hamstring muscle strengths in our study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
İstanbul, Turkey, 34440
- Tomri̇s Duymaz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- being between 40-65 years of age,
- being diagnosed with Stage 3 and 4 knee OA according to the Kellgren-Lawrence classification
Exclusion Criteria:
- any lower extremity deformity (knee flexion contracture, knee hyperextension, varus and valgus deformities),
- septic arthritis, rheumatoid arthritis,
- major dysplasia,
- congenital anomalies, acromegaly, primary osteochondromatosis,
- Ehler-Danlos syndrome,
- neuropathic arthropathy,
- hyperparathyroidism, hypothyroidism,
- diabetes mellitus,
- active synovitis,
- severe knee traumas,
- previous surgery and in the last year,
- knee arthroscopy, injections and fracture history and pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Injection
Injection containing hyaluronic acid, chondroitin sulphate and glucosamine was performed once when the knee joint was in the supine position and the knee was in the extension.
|
Injection containing hyaluronic acid, chondroitin sulphate and glucosamine is performed once when the knee joint was in the supine position and the knee is in the extension.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biodex (System 3) isokinetic systems
Time Frame: 5 minutes
|
Isokinetic test are measured with Biodex (System 3) for the measurement of quadriceps muscle strength before and 3 months after injection.
Measurements are performed at angular speeds of 60°.
Biodex (System 3) isokinetic systems are used to evaluate knee flexion angles and the muscle strengths applied at these angular velocities.
The device is set to measure at angular speeds of 60°.
Knee extension and flexion are requested and the best measurement is made.
By this measurement, the effect of injection on quadriceps isokinetic muscle strength will be determined.
|
5 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OA2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
-
The Hong Kong Polytechnic UniversityCompleted
-
Federal University of São PauloCompletedKNEE OSTEOARTHRITISBrazil
-
Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
-
Tianjin XinChen-Techfields Pharma Co., LTD.Completed
-
Eun Jung KimMinistry of Health & Welfare, Korea; Semyung UniversityUnknownOsteoarthritis KneeKorea, Republic of
-
Thammasat UniversityCompletedPrimary Knee OsteoarthritisThailand
-
Galderma R&DCompletedUnilateral Knee OsteoarthritisUnited Kingdom
Clinical Trials on Intra-articular Viscosupplement Application
-
Istanbul UniversityRecruiting
-
Dalia Salah SaifUnknownRA - Rheumatoid ArthritisEgypt
-
Seoul National University HospitalCompletedAdhesive CapsulitisKorea, Republic of
-
Istituto Ortopedico RizzoliCompleted
-
Xuanwu Hospital, BeijingNot yet recruitingAtlantoaxial Dislocation
-
St George's, University of LondonWellcome Trust; Rosetrees TrustUnknownRheumatoid Arthritis | Osteoarthritis, Knee | Psoriatic Arthritis | SpondyloarthritisUnited Kingdom
-
LabrhaStatitecCompletedKnee OsteoarthritisFrance
-
Sisli Hamidiye Etfal Training and Research HospitalCompleted
-
University Hospital TuebingenUnknownJuvenile Idiopathic ArthritisGermany
-
Procare Health Iberia S.L.CompletedOsteoarthritis, Hip | Osteoarthritis Thumb | Osteoarthritis AnkleSpain