The Effectiveness of Different Doses of Hyaluronic Acid Injections in Knee Osteoarthritis.

NCT04786613 | Completed

• 1 other identifier: Istanbul University HA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, randomized, controlled multi-centre study is to compare the effectiveness and safety of three and five injections of standard linear hyaluronic acid (HA) versus single HA injection in terms of pain intensity and functional status in patients with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Linear Hyaluronic Acid

Outcome Measures

Primary Outcomes (1)

• Change from baseline activity pain score at 1-months, 3-months and 6-months

  Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome

  Baseline, 1-month, 3-month, 6-month

Secondary Outcomes (4)

• Change from baseline rest pain score at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

• Change from baseline night pain score at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

• Change from baseline pain, stiffness and physical function at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

• Change from baseline functional balance at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

Study Arms (3)

20 mg, 1.0% hyaluronic acid injection groups

ACTIVE COMPARATOR

In the first group, 2 ml linearly linked 20 mg 1.0% hyaluronic acid injection in 5 sessions will be applied.

Other: Intra-articular 20 mg, 1.0% Hyaluronic Acid Injection

32 mg, 1.6% hyaluronic acid injection groups

ACTIVE COMPARATOR

In the second group, 2 ml linearly linked 32 mg 1.6% hyaluronic acid injection in 3 sessions will be applied.

Other: Intra-articular 32 mg, 1.6% Hyaluronic Acid Injection

48 mg, 2.0% hyaluronic acid injection groups

ACTIVE COMPARATOR

In the third group 2.4 ml linearly linked 48 mg 2.0% hyaluronic acid injection in a single sessions will be applied.

Other: Intra-articular 48 mg, 2.0% Hyaluronic Acid Injection

Interventions

Intra-articular 20 mg, 1.0% Hyaluronic Acid Injection OTHER

Intra-articular 2 ml linearly linked 20 mg 1.0% hyaluronic acid injection in 5 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

20 mg, 1.0% hyaluronic acid injection groups

Intra-articular 32 mg, 1.6% Hyaluronic Acid Injection OTHER

Intra-articular 2 ml linearly linked 32 mg 1.6% hyaluronic acid injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

32 mg, 1.6% hyaluronic acid injection groups

Intra-articular 48 mg, 2.0% Hyaluronic Acid Injection OTHER

Intra-articular 2,4 ml linearly linked 48 mg 2.0% hyaluronic acid injection in single session will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

48 mg, 2.0% hyaluronic acid injection groups

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral or bilateral symptomatic knee pain for at least three months
• Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
• Functional ambulation scale stage 4-5
• Being able to attend injection and control examinations

You may not qualify if:

• Intra-articular knee injection within the last six months
• History of severe trauma to the knee within the past six months
• Concomitant severe meniscus or ligament injury, surgery applied to the knee area
• Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
• Having a bleeding disorder and / or using warfarin
• Kellgren-Lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs
• Presence of cardiac or systemic disease that may affect exercise
• The presence of neurological disease and psychiatric disease such as Parkinson's disease, stroke history that may affect balance
• Body Mass Index ≥35 kg / m²
• Allergy to hyaluranic acid products

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatih, 34034, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Demirhan Diracoglu, Prof.

  Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Sub-Investigator

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: March 10, 2021
• Primary Completion: October 7, 2021
• Study Completion: November 7, 2021
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

TU (1)