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

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.

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Knee OA
• Intervention / Treatment: Other: Previous treated with TPX-100

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • California
    • Covina, California, United States, 91722
      • Dr. Samy Metyas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: OrthoTrophix, Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2017
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: TPX-100-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No