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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-27

Study Completion Date

2018-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Autologous Chondrocyte Implantation in the Patellofemoral Joint

NCT00212849

Chondrosis Patellar Articular Cartilage Lesions Trochlear Articular Cartilage Lesions

COMPLETED

A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis

NCT03257371

Post-traumatic Osteoarthritis

COMPLETED

The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty

NCT02760979

Bone Resorption

COMPLETED PHASE4

Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee

NCT01221441

Osteoarthritis, Knee

COMPLETED PHASE2

Bone Mineral Density Changes Under Two Tibial Components in Total Knee Arthroplasty

NCT01764984

Unilateral Primary Osteoarthritis of Knee

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild to Moderate Knee OA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Previous treated with TPX-100

No intervention, only observational

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AC-100

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No