Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis
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| ClinicalTrials.gov Identifier: NCT01557868 |
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Recruitment Status :
Completed
First Posted : March 20, 2012
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis, Knee | Device: hylan G-F 20 Device: 1% sodium hyaluronate | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 198 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Official Title: | Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis |
| Study Start Date : | October 2008 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Synvisc (hylan G-F 20) |
Device: hylan G-F 20
Three 2 cc injections at weekly intervals
Other Name: Synvisc |
| Active Comparator: Euflexxa (1% sodium hyaluronate) |
Device: 1% sodium hyaluronate
Three 2 cc injections at weekly intervals
Other Name: Euflexxa |
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale [ Time Frame: 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.
- Visual Analogue Scale (VAS) at 6 Months [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557868
| United States, Virginia | |
| Naval Medical Center Portsmouth (this site can only enroll patients who are eligible to be treated at a military facility) | |
| Portsmouth, Virginia, United States, 23708-2197 | |
| Study Chair: | Robert Marx, MD | Hospital for Special Surgery, New York | |
| Principal Investigator: | Marlene DeMaio, MD | United States Naval Medical Center, Portsmouth |
| Responsible Party: | American Orthopaedic Society for Sports Medicine |
| ClinicalTrials.gov Identifier: | NCT01557868 |
| Other Study ID Numbers: |
AOSSM 51H |
| First Posted: | March 20, 2012 Key Record Dates |
| Results First Posted: | April 2, 2014 |
| Last Update Posted: | April 2, 2014 |
| Last Verified: | February 2014 |
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Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Hyaluronic Acid |
Hylan Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |