N/A
Completed N=306
Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee
Source: ClinicalTrials.gov NCT00669032 ↗Enrolled (actual)
306
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Responders OARSI 2004 at the End of Follow-up — 80.5; 65.8 percentage of responders — p=0.004
Summary
The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responders OARSI 2004 at the End of Follow-up |
80.5; 65.8 | 0.004 sig |
| SECONDARY Responders OARSI 2004 at 7 Months Follow-up Visit |
71.1; 67.8 | 0.525 |
| SECONDARY Responders OARSI 2004 at 14 Months Follow-up Visit |
76.5; 65.1 | 0.030 sig |
| SECONDARY Responders OARSI 2004 at 21 Months Follow-up Visit |
77.9; 67.8 | 0.049 sig |
| SECONDARY Responders OARSI 2004 at 27 Months Follow-up Visit |
77.9; 67.8 | 0.049 sig |
| SECONDARY Responders OARSI 2004 at 34 Months Follow-up Visit |
81.2; 65.1 | 0.002 sig |
| SECONDARY Pain or Function Scores Reduction 50% (20mm) at the End of Follow-up |
65.1; 52.0 | 0.021 sig |
| SECONDARY Overall Pain Reduction 20% (10mm) at the End of Follow-up |
79.2; 67.8 | 0.025 sig |
| SECONDARY Function Improvement 20% (10mm) at the End of Follow-up |
70.5; 57.9 | 0.023 sig |
| SECONDARY Patient's Global Assessment Increase 20% (10mm) at the End of Follow-up |
74.5; 57.9 | 0.002 sig |
| SECONDARY Percentage of Patients Who Consumed Rescue Medication for Osteoarthritis |
71.1; 71.7 | 0.9129 |
| SECONDARY Mean Daily Dose of Paracetamol Consumption |
408.8; 451.4 | — |
Eligibility Criteria
Inclusion Criteria
- Patient > 45 years of age
- Out-patient diagnosed with primary osteoarthritis of the femorotibial medial joint of the knee with clinical and radiological (Kellgren grade II-III) ACR diagnosis
- Joint Space Width (JSW) > 2mm
- Overall pain greater or equal to 55mm (VAS - Visual Analogue Scale 100mm) recorded in the knee,by the patient at any time during the week prior to the evaluation
Exclusion Criteria
- Overweight patients (body mass index > 32).
- Pregnant and lactating women. Women of child-bearinge age not using effective contraception
- Patients who have received intra-articular hyaluronic acid within the previous year and/or intra-articular steroids or articular lavage in the chosen knee,within the previous 3 months prior to their inclusion in the study.
- AINE administration within the 14 days prior to their inclusion in the study.
- Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
- Immunocompromised patients or patients receiving systemic immunosuppressive therapy.
- Patients with known sensitivity to HA, parcetamol or AINEs permitted as rescue medication.
- Patients who have received any investigational drug within 30 days prior to visit 1, or who are scheduled for the administration of an investigational drug other than the protocol product during this study.
- Patients with severely impaired central nervous system.
- Patients with coagulation alterations, despite receiving treatment.
- Patients with secondary osteoarthritis of the knee
- Patients having previously received surgery, including arthroscopy
- Patients with articular inflammatory disease
Data sourced from ClinicalTrials.gov (NCT00669032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.