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

NCT01557868 | Completed Phase 4 Results

• 1 other identifier: AOSSM 51H
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale

  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.

  Baseline and at 6 month follow-up

Secondary Outcomes (1)

• Visual Analogue Scale (VAS) at 6 Months

  Assessments were at baseline to 6 month follow-up

Study Arms (2)

Synvisc (hylan G-F 20)

ACTIVE COMPARATOR

Device: hylan G-F 20

Euflexxa (1% sodium hyaluronate)

ACTIVE COMPARATOR

Device: 1% sodium hyaluronate

Interventions

hylan G-F 20 DEVICE

Three 2 cc injections at weekly intervals

Also known as: Synvisc

Synvisc (hylan G-F 20)

1% sodium hyaluronate DEVICE

Three 2 cc injections at weekly intervals

Also known as: Euflexxa

Euflexxa (1% sodium hyaluronate)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Orthopaedic Society for Sports Medicine: lead
• United States Naval Medical Center, Portsmouth: collaborator

Study Sites (1)

Naval Medical Center Portsmouth (this site can only enroll patients who are eligible to be treated at a military facility)

Portsmouth, Virginia, 23708-2197, United States

Location

Related Links

• Information on Osteoarthritis from the National Institutes of Health
• Cochrane Review Article Abstract on Viscosupplementation for Knee Osteoarthritis

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Barton Mann
• Organization: American Orthopaedic Society for Sports Medicine

bart@aossm.org

847-292-4900

Study Officials

• Robert Marx, MD

  Hospital for Special Surgery, New York

  STUDY CHAIR

• Marlene DeMaio, MD

  United States Naval Medical Center, Portsmouth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 20, 2012
• Study Start: October 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 2, 2014
• Results First Posted: April 2, 2014

Record last verified: 2014-02

Locations

US (1)