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
Status: | Completed |
---|---|
Conditions: | Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 25 - 75 |
Updated: | 4/17/2018 |
Start Date: | July 27, 2017 |
End Date: | March 1, 2018 |
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.
placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2.
No drug intervention. Study to collect 1 additional MRI of each knee treated in either
TPX-100-1 or TPX-100-2.
TPX-100-1 or TPX-100-2.
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.
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