Phase 4
Completed N=198
Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT01557868 ↗
Enrolled (actual)
198
Serious AEs
4.6%
Results posted
Apr 2014
Primary outcomePrimary: Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale — 12.8; 9.8 units on a scale
Summary
The purpose of this study is to evaluate whether the investigators can develop a computer algorithm to predict which individual patients will respond to injections of hyaluronic acid (HA) products for knee osteoarthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale |
12.8; 9.8 | — |
| SECONDARY Visual Analogue Scale (VAS) at 6 Months |
-13.7; -10.7 | — |
Eligibility Criteria
Inclusion Criteria
- Symptomatic knee osteoarthritis presenting to physician's office
- Radiographic evidence of knee osteoarthritis
- Age 18 years or older
- Failed minimum of 3 months of non-operative treatment, including, but not limited to, Tylenol, anti-inflammatory medication, cortisone injection, physical therapy, bracing, and/or heel wedge
- Symptoms for at least 3 months
Exclusion Criteria
- Associated ligamentous instability
- History of deep knee infection
- Candidate for total knee arthroplasty or arthroscopy
- Peripheral neuropathy.
- X-rays that are completely negative and only MRI evidence or arthroscopic evidence (from previous arthroscopy) of OA.
- Prior HA injections at any point in the past
- Chondrocalcinosis
- Patients with precautions or contraindications for viscosupplementation use
- Cortisone injection within past 3 months
Data sourced from ClinicalTrials.gov (NCT01557868). 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.