Mild to Moderate Knee OA Clinical Trial
Official title:
A Prospective Observational Study to Evaluate Long-term Changes in Cartilage Morphology in Subjects Who Previously Received TPX-100 or Placebo in Study TPX-100-1 for Patellar Osteoarthritis Involving Both Knees
| Verified date | April 2018 |
| Source | OrthoTrophix, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To evaluate the long-term changes in patellar cartilage thickness in TPX-100 versus placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | March 1, 2018 |
| Est. primary completion date | October 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 25 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Subjects who participated in TPX-100-1 and received 4 injections of 200 mg/injection TPX-100 in one knee, or subjects who participated in TPX-100 - Cruciate and collateral ligament stability as assessed by screening history and clinical examination - Stable medial and lateral menisci as assessed by screening history and clinical examination - Able to read, understand, sign and date the subject informed consent Exclusion Criteria: - Contraindication to MRI, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight > 300 lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure - Prior surgery in the knees, excluding procedures for debridement only (no previous microfracture procedure) - History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis - Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee < 3 months before enrollment - Last intra-articular knee injection of corticosteroids < 3 months before enrollment - Use of any steroids (except inhaled corticosteroids for allergy or respiratory problems) during the previous month before enrollment - History of arthroscopy in either knee in the 3 months before enrollment - History of septic arthritis, gout or pseudo-gout in either knee in the 12 months before enrollment - Clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear) - Active systemic infection - Participation in other clinical osteoarthritis drug studies, except for studies TPX-100-1 and TPX-100-2, within two years prior to enrollment in TPX-100-4. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Dr. Samy Metyas | Covina | California |
| Lead Sponsor | Collaborator |
|---|---|
| OrthoTrophix, Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the long-term changes in patellar cartilage thickness | Quantitative analysis of long-term changes in patellar cartilage thickness by MRI | Between 24 and 34 months from initial drug treatment | |
| Secondary | Examine intra-subject longitudinal changes in patellar cartilage volume between TPX-100 versus placebo-treated knees by MRI | Examine intra-subject longitudinal changes in patellar cartilage volume between TPX-100 versus placebo-treated knees by MRI | Between 24 and 34 months from initial drug treatment | |
| Secondary | Examine intra-subject longitudinal changes in thickness and thinness scores of cartilage in the central (non-patellar) compartment of knees | Examine intra-subject longitudinal changes in thickness and thinness scores of cartilage in the central (non-patellar) compartment of knees | Between 24 and 34 months from initial drug treatment | |
| Secondary | Examine intra-subject longitudinal changes in Patient reported outcome measures | Examine intra-subject longitudinal changes in Patient Reported Outcome Measures | Between 24 and 34 months from initial drug treatment |