Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis

Phase 4

Completed

Conditions: Osteoarthritis, Knee

Interventions: Device: hylan G-F 20
Device: 1% sodium hyaluronate

Registration Number: NCT01557868

Lead Sponsor: American Orthopaedic Society for Sports Medicine

Brief 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.

Detailed Description: Background Osteoarthritis (OA) of the knee is a debilitating condition that affects an estimated 21 million Americans. This number is expected to rise steadily as the population ages. The medical expenditures associated with arthritis and other rheumatic conditions in the United States have increased from $50 billion in 1997 to $86 billion in 2003. In 2003, almost 420,000 total knee replacements were performed, primarily for arthritis. Injections of hyaluronic acid (HA) have been shown to provide symptom relief for many OA patients who have failed to respond to conservative interventions. Many other patients, however, experience only slight or no improvement. The results from this study will allow physicians to identify whether a patient is likely or not likely to respond well to HA therapy leading to improved treatment success rates.

Goals This study has two related goals: 1) to identify patient and treatment factors that predict response to intra-articular injections of hyaluronic acid for knee osteoarthritis using multivariable analysis and 2) develop mathematical and statistical models that will predict individual patient response to HA for knee OA.

It is anticipated that the investigators will develop computer software in this study that can support clinical decision making related to viscosupplementation in the treatment of knee OA. If this project yields successful patient predictive models, physicians who are considering a trial of HA for a patient will have some empirical basis for treatment selection. Eventually a physician would be able to assess a relatively small number of variables for a patient and then be provided with predictions regarding treatment response.

\*\*Please note that the study site at the Naval Medical Center in Portsmouth, Virginia can only enroll patients who are eligible to be treated at a military facility.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 198

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synvisc (hylan G-F 20)	hylan G-F 20	-
Euflexxa (1% sodium hyaluronate)	1% sodium hyaluronate	-

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale	Baseline and at 6 month follow-up	The KOOS is 42-item patient-report questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It yields scores for five scales including Pain, Other Symptoms, Function in Daily Living, Function in Sport/Recreation, and Knee-Related Quality of Life. We used only the Pain scale which has a range of 0 to 100 where 100 represents the "best" score, i.e., no pain. We reported differences in baseline Pain scale score from Pain scale score at 6 months so these scores could theoretically range from -100 (moving from no pain to maximum pain) to 100 (moving from maximum pain to no pain). Positive change scores represent improvement from baseline.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) at 6 Months	Assessments were at baseline to 6 month follow-up	The VAS is a patient-reported assessment of knee pain. Patients mark on a line (0-100mm) their current level of knee pain while moving where 0 represent no pain and 100 represents maximum pain. We report changes in VAS pain rating between baseline and 6 month follow-up. Therefore scores can theoretically range from -100 (moving from maximum pain to no pain) to 100 (moving from no pain to maximum pain). Negative change scores represent decreases in perceived pain or improvement.

Trial Locations

Locations (1): Naval Medical Center Portsmouth (this site can only enroll patients who are eligible to be treated at a military facility)
🇺🇸
Portsmouth, Virginia, United States