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Study on Treating Knee Osteoarthritis with N-TEC Implant for Patients with Patellofemoral Osteoarthritis

Verified siteInvestigationalNo 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 osteoarthritis that occurs behind the kneecap, known as patellofemoral osteoarthritis. The treatment being tested is a special type of cartilage implant called N-TEC, which is made from a patient's own nasal cartilage cells. This approach is known as tissue engineered cartilage and involves using the body's own cells to help repair damaged cartilage in the knee.

The purpose of the study is to compare the effectiveness of the N-TEC implant with another treatment option. Participants in the study will be randomly assigned to receive either the N-TEC implant or a different treatment. The study will take place over a period of 24 months, during which participants will have regular check-ups to monitor their progress. These check-ups will include assessments of knee pain and function using various scales and questionnaires, such as the KOOS Pain scale, which measures knee pain and symptoms.

Throughout the study, participants will also undergo imaging tests like MRI to evaluate the condition of their knee cartilage and the success of the repair. The study aims to provide valuable information on whether the N-TEC implant can effectively reduce pain and improve knee function in people with patellofemoral osteoarthritis. Safety and any side effects will also be closely monitored to ensure the well-being of all participants.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The trial begins with an initial assessment to confirm eligibility. This includes evaluating the severity of osteoarthritis behind the kneecap using specific criteria.
Eligibility is determined by the presence of symptoms and specific grades of cartilage damage, as well as certain blood test results.
Step 2
Randomization
Participants are randomly assigned to one of two groups: one receiving the N-TEC implant and the other receiving a different treatment.
Step 3
Implantation procedure
For those in the N-TEC group, the procedure involves the implantation of engineered nasal cartilage into the knee.
This is a surgical procedure aimed at treating the affected area.
Step 4
Follow-up assessments
Participants undergo regular follow-up assessments at 6, 12, and 24 months.
These assessments include evaluating pain levels, daily activities, sports participation, and overall quality of life using various scales and questionnaires.
Step 5
Radiological evaluations
Radiological evaluations are conducted at 6, 12, and 24 months to assess the condition of the knee and the repair tissue.
These evaluations help in understanding the progress and effectiveness of the treatment.
Step 6
Final evaluation
At the end of the 24-month period, a final evaluation is conducted to compare the changes in pain and knee function between the two groups.
The primary goal is to measure the improvement in pain levels from the start of the trial.

Who can join the trial?

10 criteria

Must have **Patellofemoral osteoarthritis** (a type of arthritis affecting the knee).
Must have symptoms of **PFOA** grade 1-3 according to the **Iwano Classification** (a way to describe the severity of the condition).
Must have **Chondropathy** Grade 3-4 according to the **ICRS classification** of the patella (kneecap), trochlea femoris (part of the thigh bone), or both. **Chondropathy** refers to damage to the cartilage.
Must have a baseline score of less than 60 on the **KOOS Pain** subjective knee evaluation. This is a questionnaire that measures knee pain.
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 bending (flexion).
For women, blood tests must show at least 120g/l of **Haemoglobin** (a protein in red blood cells), 150G/l of **Platelets** (cells that help with blood clotting), and an **INR** (a measure of blood clotting) of less than 1.3.
For men, blood tests must show at least 140g/l of **Haemoglobin**, 150G/l of **Platelets**, and an **INR** of less than 1.3.
Must have tried all non-surgical standard care options, except for **PRP** (a treatment using a part of your blood), without success.
Both men and women can participate.
Participants should not be from a vulnerable population.

Who cannot join the trial?

9 criteria

Patients who have had a knee replacement surgery.
Patients with severe knee injuries that affect their ability to walk.
Patients with other types of arthritis that affect the knee.
Patients who are currently participating in another clinical trial.
Patients who have a history of allergic reactions to the study medication.
Patients who are pregnant or planning to become pregnant during the study.
Patients with uncontrolled medical conditions that could interfere with the study.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or attend study visits.

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Verified sites

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Medical Center - University Of Freiburg
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Freiburg Im Breisgau, Germany
Poliklinika Vlatka Cavka d.o.o.
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Zagreb, Croatia

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Investigated drugs

Nasal Chondrocyte-Based Engineered Cartilage Implantation is a therapy being tested in this clinical trial. It involves using cartilage cells taken from the patient's own nose. These cells are then grown and engineered in a lab to create new cartilage tissue. The engineered cartilage is implanted into the knee to help repair damage caused by patellofemoral osteoarthritis. The goal of this therapy is to reduce pain and improve knee function by regenerating healthy cartilage in the affected area.

N-Tec

What is already known about the treatment

Nasal Chondrocyte-Based Engineered Cartilage Implantation – This treatment involves the implantation of engineered cartilage derived from nasal chondrocytes, administered through a surgical procedure. It is currently being studied in a phase II clinical trial for its effectiveness in treating patellofemoral osteoarthritis. The main therapeutic indication is to alleviate pain and improve joint function in patients with this type of osteoarthritis. The mechanism of action involves the integration of the implanted cartilage into the knee joint, potentially restoring cartilage function and reducing pain. It falls under the pharmacological classification of regenerative medicine therapies.

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 results in pain and stiffness in the front of the knee, especially during activities like climbing stairs or sitting for long periods. Over time, the cartilage wears down, leading to increased friction and discomfort. The progression of the disease can lead to swelling and a decrease in the range of motion in the knee. As the condition advances, individuals may experience a grinding sensation or popping sounds in the knee. The severity of symptoms can vary, with some people experiencing mild discomfort and others facing significant mobility challenges.