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

This study has been completed.
Sponsor:
Collaborator:
United States Naval Medical Center, Portsmouth
Information provided by (Responsible Party):
American Orthopaedic Society for Sports Medicine
ClinicalTrials.gov Identifier:
NCT01557868
First received: March 12, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Device: hylan G-F 20
Device: 1% sodium hyaluronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Official Title: Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by American Orthopaedic Society for Sports Medicine:

Primary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale [ Time Frame: Baseline and at 6 month follow-up ] [ Designated as safety issue: No ]
    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:
  • Visual Analogue Scale (VAS) at 6 Months [ Time Frame: Assessments were at baseline to 6 month follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 198
Study Start Date: October 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557868

Locations
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
Sponsors and Collaborators
American Orthopaedic Society for Sports Medicine
United States Naval Medical Center, Portsmouth
Investigators
Study Chair: Robert Marx, MD Hospital for Special Surgery, New York
Principal Investigator: Marlene DeMaio, MD United States Naval Medical Center, Portsmouth
  More Information

Additional Information:
No publications provided

Responsible Party: American Orthopaedic Society for Sports Medicine
ClinicalTrials.gov Identifier: NCT01557868     History of Changes
Other Study ID Numbers: AOSSM 51H
Study First Received: March 12, 2012
Results First Received: January 7, 2014
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014