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Human Cancellous Bone

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.

Table of Contents

What is HUMAN CANCELLOUS BONE?

HUMAN CANCELLOUS BONE, also known as Spongioflex[1], 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:[1]

  • 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:[1]

  • 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:[1]

  • 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:[1]

  1. Patients will undergo regular evaluations to assess the functionality of their knee
  2. MRI (Magnetic Resonance Imaging) scans will be performed at various intervals to evaluate the condition of the meniscus and the knee joint
  3. Patients will be asked to complete questionnaires about their pain levels and overall knee function

Expected Outcomes

The main goals of this treatment are:[1]

  • 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:[1]

  • 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.

Aspect Details
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

FAQ

  • What is Human Cancellous Bone, and how is it used in this clinical trial? Human Cancellous Bone, in the form of Spongioflex® allografts, is used as a partial meniscal replacement for patients with incomplete meniscal loss. It's a sterile allogeneic transplant that aims to improve meniscus functionality and reduce pain in the affected knee.
  • Who is eligible for this clinical trial? Eligible participants are those with partial loss of lateral or medial meniscus and associated joint line pain, aged 18-60 years, with a BMI less than 30 kg/m². They must have sufficient standing of the peripheral rim for the procedure to be performed and provide written consent for the study.
  • What are the main objectives of this clinical trial? The main objectives are to improve meniscus functionality, evaluate the efficacy of the procedure using patient-reported outcome measures (PROMs), and assess the safety of the treatment. The study also aims to compare results between operated and non-operated patients over 2 and 5 years.
  • How will the effectiveness of the treatment be measured? The effectiveness will be measured using PROMs such as KOOS, IKDC, and VAS Pain Score. MRI evaluations will also be conducted to assess meniscus size, extrusion, and cartilage condition. Additionally, patient satisfaction and the progression of osteoarthritis will be monitored.
  • What are the potential benefits of participating in this clinical trial? Participants may experience improved meniscus functionality, reduced pain, and potentially slowed progression of osteoarthritis. The trial offers a novel treatment option for those with incomplete meniscal loss who may not have had suitable alternatives previously.

Ongoing Clinical Trials on Human Cancellous Bone

  • Study on Human Cancellous Bone for Partial Meniscal Replacement in Patients with Incomplete Meniscal Loss

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Meniscus: A C-shaped piece of cartilage that acts as a cushion between the thighbone (femur) and shinbone (tibia) in the knee joint.
  • Allograft: Tissue transplanted from one person to another, in this case, Human Cancellous Bone from a donor.
  • Spongioflex®: A specific type of allograft made from Human Cancellous Bone, used for partial meniscal replacement in this trial.
  • PROMs: Patient-Reported Outcome Measures, which are questionnaires used to assess a patient's health status or quality of life from their own perspective.
  • KOOS: Knee Injury and Osteoarthritis Outcome Score, a standardized questionnaire used to evaluate knee-related symptoms and function.
  • IKDC: International Knee Documentation Committee score, a tool used to measure knee-specific symptoms, function, and sports activity.
  • VAS Pain Score: Visual Analogue Scale for Pain, a measurement tool used to assess pain intensity on a continuous scale.
  • MRI: Magnetic Resonance Imaging, a non-invasive imaging technique used to visualize internal structures of the body, including the knee joint and meniscus.
  • Osteoarthritis: A degenerative joint disease characterized by the breakdown of cartilage and underlying bone, often causing pain and stiffness.
  • TKA: Total Knee Arthroplasty, a surgical procedure to replace the entire knee joint with an artificial joint.
  • Outerbridge graduation: A classification system used to grade the severity of cartilage damage in joints.
  • Extrusion: In the context of meniscus, it refers to the displacement of the meniscus outside the joint space.

References

  1. http://clinicaltrials.eu/trial/study-on-human-cancellous-bone-for-partial-meniscal-replacement-in-patients-with-incomplete-meniscal-loss/