Intra-articular Viscosupplement Application in Knee Osteoarthritis

• Sponsor: Istanbul Bilgi University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03913052
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5.2
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Procedure: Intra-articular Viscosupplement Application	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Nov 2, 2018
• Actual Primary Completion Date: Feb 28, 2019
• Anticipated Study Completion Date: Apr 10, 2019

Arms and Interventions

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.	Procedure: Intra-articular Viscosupplement Application; 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: intra-articular injection

Outcome Measures

Primary Outcome Measures

1. Biodex (System 3) isokinetic systems [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tomri̇s Duymaz	İstanbul		Turkey	34440

Sponsors and Collaborators

• Istanbul Bilgi University

Investigators

• Principal Investigator: Tomri̇s Duymaz, Istanbul Bilgi University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TOMRIS DUYMAZ, Asst. Prof. Ph.D., Istanbul Bilgi University
• ClinicalTrials.gov Identifier: NCT03913052
• Other Study ID Numbers: OA2018
• First Posted: Apr 12, 2019
• Last Update Posted: Apr 12, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Viscosupplements

Study Results

No Results Posted as of Apr 12, 2019