Clinical trial NCT03125499: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild to Moderate Knee OA
Lead sponsor: OrthoTrophix, Inc
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 54
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with bi-lateral knee OA that have previous been treated in TPX-100-1 or TPX-100-2

Brief 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.

Detailed description: No drug intervention. Study to collect 1 additional MRI of each knee treated in either TPX-100-1 or TPX-100-2.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the long-term changes in patellar cartilage thickness
timeFrame: Between 24 and 34 months from initial drug treatment
Secondary outcomes:
measure: Examine intra-subject longitudinal changes in patellar cartilage volume between TPX-100 versus placebo-treated knees by MRI
timeFrame: Between 24 and 34 months from initial drug treatment
measure: Examine intra-subject longitudinal changes in thickness and thinness scores of cartilage in the central (non-patellar) compartment of knees
timeFrame: Between 24 and 34 months from initial drug treatment
measure: Examine intra-subject longitudinal changes in Patient reported outcome measures
timeFrame: Between 24 and 34 months from initial drug treatment
Other outcomes:
Locations:
city: Covina
country: United States
facility: Dr. Samy Metyas
state: California
Study officials:
References: