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Study on Treating Knee Osteoarthritis with Nasal Cartilage Implantation for Patients with Patellofemoral Osteoarthritis

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of patellofemoral osteoarthritis, a type of arthritis that affects the area behind the kneecap. The study will use a treatment called N-TEC, which is a special type of implant made from engineered nasal cartilage cells. This treatment will be compared to the current standard care for this condition. The purpose of the study is to determine if the N-TEC implant can provide better outcomes for patients than the existing treatments.

Participants in the study will receive either the N-TEC implant or the standard treatment. The study will follow participants over a period of 24 months to observe changes in their condition. The main focus will be on improvements in knee function and pain, as measured by a specific scoring system. Additional assessments will include various health and activity scales, as well as imaging tests like MRI and X-rays, to monitor the progress of the treatment.

The trial aims to gather data on the effectiveness and safety of the N-TEC implant compared to the standard treatment. By the end of the study, researchers hope to have a clearer understanding of whether this new approach can offer better relief and improved quality of life for those suffering from patellofemoral osteoarthritis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to evaluate your current health status and the condition of your knee. This will include a series of questionnaires and physical examinations to establish a baseline for your knee function and pain levels.
You will be asked to complete the KOOS-5 questionnaire, which assesses your knee-related quality of life. This will help in tracking changes over the course of the study.
Step 2
Implantation procedure
If you are selected for the treatment group, you will undergo a procedure where the N-TEC implant, a tissue-engineered nasal cartilage, will be placed in your knee. This is done through a surgical process called implantation.
The procedure aims to improve the condition of your knee by replacing damaged cartilage with the engineered implant.
Step 3
Recovery and follow-up
After the implantation, you will enter a recovery phase. Regular follow-up visits will be scheduled to monitor your progress and the condition of your knee.
You will be required to complete various assessments at 6, 12, and 24 months, including the KOOS-5, Kujala Anterior Knee Pain Scale, WOMAC Score, and EQ-5D-5L. These assessments will help track your knee function, pain levels, and overall quality of life.
Step 4
Imaging and safety checks
Throughout the study, imaging tests such as MRI and X-ray will be conducted at baseline, 6, 12, and 24 months to visualize the condition of your knee and the implant.
Safety will be closely monitored by tracking any adverse reactions or complications related to the treatment. This ensures that any issues are addressed promptly.
Step 5
Final evaluation
At the end of the 24-month period, a final evaluation will be conducted to assess the overall outcome of the treatment. This will include a comprehensive review of all the data collected during the study.
You will be asked to complete a Patient Satisfaction Questionnaire to provide feedback on your experience and the results of the treatment.

Who can join the trial?

6 criteria

Patient age must be between 18 and 70 years at the time of screening.
Patient must have symptomatic patellofemoral osteoarthritis (PFOA) graded between 1 and 4 according to the Iwano Classification. This means the patient has knee pain and changes in the knee joint as classified by a specific medical system.
Patient must have chondropathy (damage to the cartilage) graded between 3 and 4 according to the ICRS classification, affecting the kneecap (patella), the groove at the end of the thigh bone (trochlea femoris), or both.
Patient must have a baseline score of less than 75 on the KOOS-5 subjective knee evaluation. This is a questionnaire that measures the patient's opinion about their knee function.
Patient must have a free range of motion in the affected knee joint, or no more than 5 degrees of extension loss and at least 125 degrees of flexion. This means the knee should be able to move almost fully.
Patient must be willing and able to give written informed consent. This means the patient agrees to participate in the study after understanding all the details and implications.

Who cannot join the trial?

7 criteria

Patients with any other type of arthritis besides patellofemoral osteoarthritis cannot participate. Arthritis is a condition that causes pain and swelling in the joints.
Patients who have had surgery on their knee in the last 6 months are not eligible.
Patients with a history of allergic reactions to the materials used in the study cannot join. An allergic reaction is when your body reacts badly to something, like a rash or difficulty breathing.
Patients who are currently participating in another clinical trial are not allowed to join this study.
Patients with severe medical conditions that could interfere with the study results are excluded. Severe medical conditions are serious health problems that need special attention.
Pregnant or breastfeeding women cannot participate in the study.
Patients who are unable to follow the study procedures or attend follow-up visits are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Ospedale Galeazzi S.p.A.
Responsive
Milan, Italy
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Verified
Gothenburg, Sweden
Universita' Campus Bio-medico Di Roma
Verified
Rome, Italy

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Investigated drugs

N-TEC
is a new type of treatment that uses tissue engineered cartilage made from nasal chondrocytes. This means that cells from the nose are used to create a special kind of cartilage that can be implanted into the knee. The goal of this treatment is to help improve the condition of the knee joint in people with patellofemoral osteoarthritis, which is a type of arthritis that affects the front part of the knee. By using this engineered cartilage, the treatment aims to provide better support and cushioning in the knee, potentially leading to less pain and better movement over time.
AMIC
stands for Autologous Matrix-Induced Chondrogenesis. It is a procedure used to treat damaged cartilage in the knee. In this treatment, a special matrix or scaffold is placed over the damaged area of the knee cartilage. This matrix helps the body’s own cells to grow and repair the damaged cartilage. The goal of AMIC is to improve the function of the knee and reduce pain by encouraging the body to heal itself more effectively.

N-Tec

What is already known about the treatment

N-TEC – N-TEC is a treatment administered through nasal chondrocyte-based tissue engineered cartilage implantation, specifically designed for individuals with patellofemoral osteoarthritis. Currently, it is being evaluated in a phase II clinical trial to determine its effectiveness compared to the standard treatment. The main goal of N-TEC is to improve joint function and reduce pain by using engineered cartilage to repair damaged areas. This innovative approach works at the molecular level by promoting the growth and integration of new cartilage cells in the affected joint. N-TEC falls under the category of regenerative medicine, which focuses on repairing or replacing damaged tissues.

Investigated diseases

Patellofemoral osteoarthritis – This condition involves the degeneration of cartilage in the patellofemoral joint, which is where the kneecap meets the thigh bone. It typically begins with the softening and breakdown of cartilage, leading to pain and stiffness in the knee. As the disease progresses, the cartilage wears away, causing bones to rub against each other. This can result in increased pain, swelling, and reduced mobility. Over time, the joint may become deformed, and bone spurs can develop. The progression of symptoms can vary, with some individuals experiencing gradual worsening, while others may have periods of stability.