Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Synvisc (hylan G-F 20)
|
Device: hylan G-F 20
Three 2 cc injections at weekly intervals
Other Names:
|
| Active Comparator: Euflexxa (1% sodium hyaluronate)
|
Device: 1% sodium hyaluronate
Three 2 cc injections at weekly intervals
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Information on Osteoarthritis from the National Institutes of Health
- Cochrane Review Article Abstract on Viscosupplementation for Knee Osteoarthritis
Publications
None provided.- AOSSM 51H
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Synvisc (Hylan G-F 20) | Euflexxa (1% Sodium Hyaluronate) |
|---|---|---|
| Arm/Group Description | hylan G-F 20: Three 2 cc injections at weekly intervals | 1% sodium hyaluronate: Three 2 cc injections at weekly intervals |
| Period Title: Overall Study | ||
| STARTED | 103 | 95 |
| COMPLETED | 76 | 65 |
| NOT COMPLETED | 27 | 30 |
Baseline Characteristics
| Arm/Group Title | Synvisc (Hylan G-F 20) | Euflexxa (1% Sodium Hyaluronate) | Total |
|---|---|---|---|
| Arm/Group Description | hylan G-F 20: Three 2 cc injections at weekly intervals | 1% sodium hyaluronate: Three 2 cc injections at weekly intervals | Total of all reporting groups |
| Overall Participants | 103 | 95 | 198 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
46.5
(9.6)
|
43.3
(10.4)
|
45.0
(10.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
43
41.7%
|
35
36.8%
|
78
39.4%
|
| Male |
60
58.3%
|
60
63.2%
|
120
60.6%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Asian |
1
1%
|
5
5.3%
|
6
3%
|
| Black/African American |
33
32%
|
21
22.1%
|
54
27.3%
|
| Hispanic |
5
4.9%
|
6
6.3%
|
11
5.6%
|
| White |
62
60.2%
|
62
65.3%
|
124
62.6%
|
| Other |
2
1.9%
|
1
1.1%
|
3
1.5%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
103
100%
|
95
100%
|
198
100%
|
Outcome Measures
| Title | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale |
|---|---|
| Description | 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. |
| Time Frame | Baseline and at 6 month follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Synvisc (Hylan G-F 20) | Euflexxa (1% Sodium Hyaluronate) |
|---|---|---|
| Arm/Group Description | hylan G-F 20: Three 2 cc injections at weekly intervals | 1% sodium hyaluronate: Three 2 cc injections at weekly intervals |
| Measure Participants | 76 | 65 |
| Mean (Standard Deviation) [units on a scale] |
12.8
(18.9)
|
9.8
(20.5)
|
| Title | Visual Analogue Scale (VAS) at 6 Months |
|---|---|
| Description | 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. |
| Time Frame | Assessments were at baseline to 6 month follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| The discrepancy between the number of subjects included in this analysis (140) and the number of subjects reported completing the study (141) is due to a missing values for one subject for this variable. |
| Arm/Group Title | Synvisc (Hylan G-F 20) | Euflexxa (1% Sodium Hyaluronate) |
|---|---|---|
| Arm/Group Description | hylan G-F 20: Three 2 cc injections at weekly intervals | 1% sodium hyaluronate: Three 2 cc injections at weekly intervals |
| Measure Participants | 76 | 64 |
| Mean (Standard Deviation) [units on a scale] |
-13.7
(28.4)
|
-10.7
(25.4)
|
Adverse Events
| Time Frame | 1 year | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Synvisc (Hylan G-F 20) | Euflexxa (1% Sodium Hyaluronate) | ||
| Arm/Group Description | hylan G-F 20: Three 2 cc injections at weekly intervals | 1% sodium hyaluronate: Three 2 cc injections at weekly intervals | ||
All Cause Mortality |
||||
| Synvisc (Hylan G-F 20) | Euflexxa (1% Sodium Hyaluronate) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Synvisc (Hylan G-F 20) | Euflexxa (1% Sodium Hyaluronate) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/103 (7.8%) | 1/95 (1.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Knee Effusion | 8/103 (7.8%) | 8 | 1/95 (1.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Synvisc (Hylan G-F 20) | Euflexxa (1% Sodium Hyaluronate) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/103 (0%) | 0/95 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Barton Mann |
|---|---|
| Organization | American Orthopaedic Society for Sports Medicine |
| Phone | 847-292-4900 |
| bart@aossm.org |
- AOSSM 51H