Osteoarthritis (OA) of the Knee, Osteoarthritis, Osteoarthritis in the Knee, Osteoarthritis of Knee, Osteoarthritis of the Knees, Osteoarthritis of Knee Joint, Osteoarthritis Knee, Osteoarthritis of the Knee
Conditions
Keywords
osteoarthritis, hyaluronic acid, steroid injection, kellgren lawrence, oa, arthritis
Brief summary
The aim of this study is to compare functional and clinical outcomes of intraarticular injections of hyaluronic acid and steroids in patients with bilateral knee osteoarthritis. We will compare clinical and functional outcomes for each knee separately after week 6, month 3, month 6, and one year after the intervention.
Detailed description
We will include patients with bilateral knee osteoarthritis (Kellgren Lawrence grades 2 and 3). On initial examination, we will measure active and passive range of flexion and extension, presence of swelling, joint effusion, VAS score for each knee separately, and WOMAC score for every knee separately. We will randomly apply hyaluronic acid injection in one knee and steroid injection in the other knee. We will repeat the same examination after week 6, month 3, month 6, and one year after the procedure. The main aim is to check whether there is a significant clinical or functional difference between two groups.
Interventions
The patient will receive one 3mL Sodium Hyaluronate injection containing 75 mg of active substance in one knee joint.
The patient will receive 2mL of methylprednisolone acetate solution containing 80 mg of the medicine in other knee joint.
Sponsors
Edin Mešanović
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Patients with bilateral knee osteoarthritis will receive hyaluronic acid injection in one knee and steroid injection in the other knee.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* bilateral knee pain * same grade of osteoarthritis in both knees * Kellgren-Lawrence grade 2 or 3 of knee osteoarthritis * fully completed all follow-up examinations
Exclusion criteria
* unilateral knee osteoarthritis * different grade of osteoarthritis between knees based on Kellgren-Lawrence scale * positive history of previous knee interventions (injections, surgery) * positive history of additional knee injuries (meniscus, ligament...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC score | One year after the intervention. | Changes in WOMAC score one year after the intervention compared to the WOMAC score at the initial examination. |
| VAS score | One year after the intervention. | Changes in VAS score after one year. |
| Range of active knee joint flexion | One year after the intervention. | Changes in the range of active knee joint flexion |
| Range of active knee joint extension | One year after the intervention. | Changes in the range of active knee joint extension |
| Knee swelling | One year after the intervention. | Presence of knee joint swelling. |
| Knee joint effusion | One year after the intervention. | The presence of knee joint effusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of active knee joint flexion after 6 months | 6 months after the intervention. | Changes in the range of knee joint flexion compared to the initial examination. |
| WOMAC score after 3 months | 3 months after the intervention. | Changes in WOMAC score compared to the initial examination. |
| VAS score after 3 months | 3 months after the intervention. | Changes in VAS score compared to the initial examination. |
| Range of active knee joint flexion after 3 months | 3 months after the intervention. | Changes in the range of knee joint flexion compared to the initial examination. |
| Range of active knee joint extension after 3 months | 3 months after the intervention. | Changes in the range of knee joint extension compared to the initial examination. |
| Knee swelling after 3 months | 3 months after the intervention. | Changes in the presence of knee swelling compared to the initial examination. |
| WOMAC score after 6 weeks | 6 weeks after the intervention. | Changes in WOMAC score compared to the initial examination. |
| WOMAC score after 6 months | 6 months after the intervention. | Changes in WOMAC score compared to the initial examination. |
| VAS score after 6 months | 6 months after the intervention. | Changes in VAS score compared to the initial examination. |
| Range of active knee joint extension after 6 months | 6 months after the intervention. | Changes in the range of knee joint extension compared to the initial examination. |
| Knee swelling after 6 months | 6 months after the intervention. | Changes in the presence of knee swelling compared to the initial examination. |
| Knee joint effusion after 6 months | 6 months after the intervention. | Changes in the presence of knee effusion compared to the initial examination. |
| Knee joint effusion after 3 months | 3 months after the intervention. | Changes in the presence of knee joint effusion compared to the initial examination. |
| VAS score after 6 weeks | 6 weeks after the intervention. | Changes in VAS score compared to the initial examination. |
| Range of active knee joint flexion after 6 weeks | 6 weeks after the intervention. | Changes in range of active knee joint flexion compared to the initial examination. |
| Range of active knee joint extension after 6 weeks | 6 weeks after the intervention. | Changes in the range of knee joint extension compared to the initial examination. |
| Knee swelling after 6 weeks | 6 weeks after the intervention. | Changes in the presence of knee swelling compared to the initial examination. |
| Knee joint effusion after 6 weeks | 6 weeks after the intervention. | Changes in the presence of knee joint effusion compared to the initial examination. |
Countries
Bosnia and Herzegovina
Outcome results
None listed