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

NCT03125499 | Completed

• 1 other identifier: TPX-100-4
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate Knee OA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  Between 24 and 34 months from initial drug treatment

• Examine intra-subject longitudinal changes in Patient reported outcome measures

  Between 24 and 34 months from initial drug treatment

Interventions

Previous treated with TPX-100 OTHER

No intervention, only observational

Also known as: AC-100

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• OrthoTrophix, Inc: lead

Study Sites (1)

Dr. Samy Metyas

Covina, California, 91722, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 24, 2017
• Study Start: July 27, 2017
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)