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Intra-articular Viscosupplement Application in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intra-articular Viscosupplement Application
Sponsored by
Istanbul Bilgi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tomri̇s Duymaz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Injection

Arm Description

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.

Outcomes

Primary Outcome Measures

Biodex (System 3) isokinetic systems
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.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2019
Last Updated
April 11, 2019
Sponsor
Istanbul Bilgi University
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1. Study Identification

Unique Protocol Identification Number
NCT03913052
Brief Title
Intra-articular Viscosupplement Application in Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
April 10, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Bilgi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intra-articular Viscosupplement Application
Other Intervention Name(s)
intra-articular injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biodex (System 3) isokinetic systems
Description
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.
Time Frame
5 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomri̇s Duymaz
Organizational Affiliation
Istanbul Bilgi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tomri̇s Duymaz
City
İstanbul
ZIP/Postal Code
34440
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intra-articular Viscosupplement Application in Knee Osteoarthritis

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