In short
This article explores the use of Human Cancellous Bone, specifically Spongioflex® allografts, in clinical trials for partial meniscal replacement in patients with incomplete meniscal loss. The study aims to improve meniscus functionality and evaluate the efficacy and safety of this innovative treatment approach. We'll discuss the trial objectives, eligibility criteria, and potential benefits for patients suffering from meniscus-related issues.
At a glance
- Study Title
- Sterile allogeneic spongioflex® allografts as partial meniscal replacement after incomplete meniscal loss
- Main Objective
- Improve meniscus functionality and evaluate efficacy using PROMs
- Treatment
- Human Cancellous Bone (Spongioflex®) for partial meniscal replacement
- Eligibility
- Patients aged 18-60 with partial meniscal loss and associated joint line pain
- Primary Outcome
- Improvement in PROMs (KOOS, IKDC, VAS Pain Score) at 2 and 5 years post-surgery
- Secondary Outcomes
- Safety assessment, osteoarthritis progression, MRI evaluation, patient satisfaction
- Study Design
- Comparison between operated and non-operated groups over 2 and 5 years
- Key Exclusions
- ACL insufficiency, chronic pain, inflammatory arthritis, advanced cartilage damage
What is HUMAN CANCELLOUS BONE?
HUMAN CANCELLOUS BONE, also known as Spongioflex, is a medical product used for partial meniscal replacement in patients with incomplete meniscal loss. It is classified as a transplant of human origin, which means it is derived from human tissue. This product is being studied as a potential treatment for certain knee conditions.
Medical Conditions Treated
The primary medical condition that HUMAN CANCELLOUS BONE aims to treat is incomplete meniscal loss. This condition can occur due to various reasons, including:
- Meniscus tears: These can include bucket handle tears of the medial or lateral meniscus
- Derangement of the meniscus: This refers to structural problems in different parts of the meniscus, such as the anterior horn, posterior horn, or the entire medial or lateral meniscus
- Old injuries to the meniscus that have not healed properly
The meniscus is a C-shaped piece of cartilage in your knee that acts as a cushion between your thighbone and shinbone. When it's damaged or partially missing, it can cause pain and affect the knee's functionality.
How It Works
HUMAN CANCELLOUS BONE is used as a partial meniscal replacement. This means it's designed to replace the part of the meniscus that has been lost or damaged. The procedure aims to:
- Improve the functionality of the meniscus
- Reduce pain in the affected knee
- Potentially slow down the progression of osteoarthritis in the knee
The product is a sterile allograft, which means it's tissue taken from a donor and processed to be safe for use in another person's body.
Eligibility for Treatment
Not everyone with meniscus problems is eligible for this treatment. Some key eligibility criteria include:
- Partial loss of portions of the lateral or medial meniscus with associated joint line pain
- Sufficient standing of the peripheral rim of the meniscus
- Age between 18 and 60 years
- Body Mass Index (BMI) less than or equal to 30 kg/m²
Certain conditions may make a person ineligible for this treatment, such as:
- Chronic pain conditions
- Inflammatory arthritis or synovitis in the affected knee
- Advanced cartilage damage or osteoarthritis in the affected knee compartment
- Significant knee extension deficit or limited flexion
- Pregnancy (for patients considering surgery)
Treatment Process
The treatment involves a surgical procedure to implant the HUMAN CANCELLOUS BONE material. After the surgery:
- Patients will undergo regular evaluations to assess the functionality of their knee
- MRI (Magnetic Resonance Imaging) scans will be performed at various intervals to evaluate the condition of the meniscus and the knee joint
- Patients will be asked to complete questionnaires about their pain levels and overall knee function
Expected Outcomes
The main goals of this treatment are:
- Improvement in knee functionality
- Reduction in pain
- Better scores on standardized knee assessment tools (like KOOS and IKDC)
- Potential slowing of osteoarthritis progression
Patient satisfaction will be assessed after 2 and 5 years following the surgery.
Safety and Side Effects
As with any medical procedure, there are potential risks and side effects. The study is designed to monitor:
- The type, frequency, and severity of treatment-related adverse events
- Any serious adverse events that may occur
It's important to discuss potential risks and benefits with your healthcare provider before considering this treatment.