Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated due to poor enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more effective in treating the symptoms of knee OA then treating with viscosupplementation alone
A randomized prospective study to assess the effectiveness of treating knee osteoarthritis with either a series of three viscosupplementation injections, an off-loading knee brace, or a combination of viscosupplementation and an off-loading knee brace. The viscosupplementation and off-loading knee brace are being used in accordance with their FDA approval. Subjects will be randomized to 1 of 3 treatment groups. The control group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections. The second group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections and an off loading knee brace. The third group will use the off loading knee brace alone. Subjects will complete the WOMAC Osteoarthritis Questionnaire (pain, stiffness, function) and VAS pain scale (measuring pain on movement) at baseline, day 7, day 14, 6 weeks and 3 months. Subjects in group 2 and 3 will be given a brace diary to record compliance.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viscosupplementation injections | Other | Control group will receive a series of three viscosupplementation injections into the affected knee |
|
| Off-loading knee brace | Experimental |
| |
| Viscosupplementation and knee brace | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthovisc | Other | Subjects will receive a series of three Orthovisc injections into their affected knee |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in knee pain | The primary outcome measure will be a reduction in knee pain as measured by the VAS pain score. The secondary outcome measure will be an increase in function as measured by the WOMAC Osteoarthritis Questionnaire. | 3 months |
Not provided
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William R Sterba, MD | OAD Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OAD Orthopaedics | Warrenville | Illinois | 60555 | United States |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C477349 | orthovisc |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DonJoy HA lite knee brace | Device | Subjects will be fitted and educated on using the DonJoy HA lite knee brace to treat their affected knee |
|
| Orthovisc injections and DonJoy HA lite knee brace | Device | Subjects will receive a series of three Orthovisc injections and be fitted and educated on using a DonJoy HA lite knee brace |
|
| D012216 |
| Rheumatic Diseases |