CClinicalTrials.gg
Status unknownNCT03913052Updated Apr 12, 2019

Intra-articular Viscosupplement Application in Knee Osteoarthritis

An interventional study of Intra-articular Viscosupplement Application in Knee Osteoarthritis, sponsored by Istanbul Bilgi University. Status unknown at 1 site in Turkey. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-12.

Sponsored by Istanbul Bilgi University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2018, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
40 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 15 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Istanbul Bilgi University is the lead sponsor of 50 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureIntra-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.

    Also known as: intra-articular injection

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 minutes

07

Study locations

1 site
  • Tomri̇s Duymaz
    İstanbul, 34440, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03913052
Lead sponsor
Istanbul Bilgi University
Responsible party
TOMRIS DUYMAZ (Asst. Prof. Ph.D., Istanbul Bilgi University) — Principal investigator
First posted
Apr 12, 2019
Start date
Nov 2, 2018
Primary completion
Feb 28, 2019
Completion
Apr 10, 2019 (estimated)
Last update
Apr 12, 2019

Study contacts

Tomri̇s Duymaz
principal investigator · Istanbul Bilgi University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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