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

Registered drugNo 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 effects of using a special type of bone transplant called human cancellous bone to help people who have experienced an incomplete meniscal loss. The meniscus is a part of the knee that acts like a cushion between the bones. When part of it is lost, it can cause pain and affect knee function. The trial aims to see if using these bone transplants can improve the function of the meniscus and reduce pain for those affected.

The study will involve participants who have lost part of their meniscus and are experiencing pain in the knee joint. The treatment involves using a sterile allogeneic spongioflex® allograft, which is a type of bone graft from a donor, to replace the missing part of the meniscus. The goal is to improve knee function and reduce pain over time. Participants will be monitored and compared to those who do not receive the treatment to see how effective the procedure is.

Throughout the study, participants will be evaluated at different times, including at the start, and then again after 2 and 5 years. This will help researchers understand how well the treatment works over a longer period. The study will also look at the safety of the procedure by checking for any side effects. Additionally, the study will assess patient satisfaction with the treatment. The trial is expected to continue until 2031, providing valuable insights into the long-term benefits and safety of using bone transplants for meniscal repair.

The research process

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

  1. Step 1

    Joining the study

    Participation begins after providing written consent to the study and agreeing to share scientific data in a pseudonymized form.

    Eligibility includes partial loss of the meniscus with joint line pain, age between 18 and 60 years, and sufficient standing of the peripheral rim for the procedure.

  2. Step 2

    Surgical procedure

    The procedure involves the use of sterile allogeneic spongioflex® allografts for partial meniscal replacement.

    The goal is to improve meniscus functionality after incomplete meniscal loss.

  3. Step 3

    Post-surgery evaluation

    The effectiveness of the procedure is assessed using patient-reported outcome measures (PROMs) such as IKDC, KOOS, and VAS pain score.

    Comparisons are made between operated and non-operated patients, as well as pre-surgery and post-surgery scores at 2 and 5 years.

  4. Step 4

    Safety monitoring

    Safety is evaluated by monitoring the type, frequency, and severity of any treatment-related adverse events (AEs) and serious adverse events (SAEs).

  5. Step 5

    MRI evaluations

    MRI scans are conducted to assess the size of the meniscus, any extrusion, and the progression of osteoarthrosis.

    Evaluations occur at 6 weeks, 6 months, 12 months, and after 2 and 5 years for operated patients.

  6. Step 6

    Patient satisfaction

    Patient satisfaction is measured at 2 and 5 years post-surgery, with categories including very pleased, pleased, not pleased, and very unsatisfied.

Who can join the trial?

4 criteria

  • The patient must have a partial loss of parts of the lateral meniscus with pain on the outer side of the knee, or a partial loss of the medial meniscus with pain on the inner side of the knee. The meniscus is a piece of cartilage in the knee that helps cushion and stabilize the joint.
  • The patient must be between the ages of 18 and 60 years.
  • The patient must provide written consent to participate in the study and agree to have their data used in a way that does not reveal their identity.
  • The patient must have enough of the outer edge of the meniscus intact so that the procedure can be performed. The outer edge is important for the stability and function of the meniscus.

Who cannot join the trial?

4 criteria

  • Patients with a condition called incomplete meniscal loss cannot participate. This means that part of the meniscus, which is a piece of cartilage in the knee, is missing.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
  • Patients who are considered part of a vulnerable population, which means they might need special protection, cannot participate.
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Investigated drugs

Spongioflex® Allografts are used in this clinical trial as a partial replacement for the meniscus in patients who have experienced incomplete meniscal loss. These allografts are sterile and derived from donor tissue, designed to help restore the function of the damaged meniscus. The goal is to improve knee functionality and reduce pain, allowing patients to regain better movement and quality of life. The effectiveness of this treatment will be evaluated by comparing patient-reported outcomes over time.

What is already known about the treatment

Spongioflex® Allografts – This medication is administered as a surgical implant, specifically designed for partial meniscal replacement in cases of incomplete meniscal loss. Currently, it is under investigation in clinical trials to assess its effectiveness in improving meniscus functionality. The main therapeutic indication is to restore the function of the knee meniscus, potentially reducing pain and improving joint stability. At the molecular level, the allograft works by integrating with the patient's existing tissue, promoting healing and structural support. It is classified as a biological implant used in orthopedic procedures.

Investigated diseases

Incomplete Meniscal Loss – This condition involves the partial loss of the meniscus, which is a C-shaped piece of cartilage in the knee that acts as a cushion between the thighbone and shinbone. The meniscus helps to stabilize the knee joint and distribute weight evenly across the knee. When part of the meniscus is lost, it can lead to increased stress on the knee joint, potentially causing pain and swelling. Over time, this condition may result in reduced knee function and difficulty in performing activities that involve bending or twisting the knee. The progression of incomplete meniscal loss can vary, with some individuals experiencing gradual worsening of symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508271-36-00Estimated enrolment30 patientsSponsorDr. Sven Behrendt, Knie und Schulterchirurgie

sourced from the EU Clinical Trials Register and site verification

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