A Prospective Observational Study to Evaluate Long-term Changes in Cartilage Morphology in Subjec… (NCT03125499) | Clinical Trial Compass
CompletedNot Applicable
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
United States54 participantsStarted 2017-07-27
Plain-language summary
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.
Who can participate
Age range25 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 men…
What they're measuring
1
Evaluate the long-term changes in patellar cartilage thickness
Timeframe: Between 24 and 34 months from initial drug treatment