Ongoing Clinical Trials for Meniscus Injury
Currently, there is 1 ongoing clinical trial investigating treatment options for meniscus injury. This trial is exploring the use of bone transplants to help restore knee function and reduce pain in patients who have experienced partial loss of the meniscus, a crucial cushioning structure in the knee joint.
Clinical trial locations
Study on Human Cancellous Bone for Partial Meniscal Replacement in Patients with Incomplete Meniscal Loss
This clinical trial is investigating an innovative approach to treating incomplete meniscal loss using bone transplants. The meniscus is a C-shaped piece of cartilage in the knee that acts as a cushion between the thighbone and shinbone, helping to stabilize the joint and distribute weight evenly. When part of it is damaged or lost, patients often experience pain, swelling, and difficulty with knee movement.
Main inclusion criteria:
- Patients must have partial loss of either the lateral meniscus (outer side) with pain on the outer knee, or partial loss of the medial meniscus (inner side) with pain on the inner knee
- Age between 18 and 60 years
- Must provide written consent to participate and agree to share data in a way that protects their identity
- Must have enough of the outer edge of the meniscus remaining intact for the procedure to be performed, as this edge is important for meniscus stability and function
Main exclusion criteria:
- Patients who do not fall within the specified age range
- Patients who belong to certain clinical trial groups not included in this study
- Patients considered part of a vulnerable population requiring special protection
Focus and goal of the trial:
The trial aims to evaluate whether using Spongioflex® allografts, a special type of sterile bone graft from a donor, can improve knee function and reduce pain in patients with incomplete meniscal loss. The procedure involves surgically implanting these bone grafts to replace the missing part of the meniscus, with the goal of restoring the cushioning and stabilizing function of this important knee structure.
The study will monitor participants at multiple time points: at the start of the study, and then at 2 and 5 years after the procedure. This long-term follow-up, extending until 2031, will help researchers understand how well the treatment works over time and whether improvements are sustained.
Effectiveness will be measured using patient-reported outcomes, including standardized questionnaires such as IKDC, KOOS, and pain scores. The study will compare results between patients who receive the treatment and those who do not, as well as comparing each patient’s condition before and after surgery. MRI scans will also be performed at various intervals (6 weeks, 6 months, 12 months, 2 years, and 5 years) to assess the size of the meniscus, any displacement, and the progression of joint degeneration.
Investigational treatment:
The trial uses Spongioflex® allografts, which are sterile bone grafts derived from human donor tissue. These allografts are designed to integrate with the patient’s existing tissue, promoting healing and providing structural support. The procedure involves surgical implantation of these grafts to partially replace the damaged meniscus. Safety will be monitored throughout the study by tracking any adverse events or complications related to the treatment. Patient satisfaction will also be assessed at 2 and 5 years after surgery.
Summary
Currently, only one clinical trial is actively recruiting patients with meniscus injury. This trial, conducted in Germany, represents a specialized approach to treating incomplete meniscal loss using bone allograft transplantation. The study focuses on a specific patient population aged 18 to 60 years who have experienced partial meniscal loss with accompanying knee pain.
The trial is notable for its long-term follow-up period, extending to 5 years post-surgery, which will provide valuable insights into the durability and sustained effectiveness of this treatment approach. The use of Spongioflex® allografts represents an innovative biological solution aimed at restoring the natural cushioning function of the meniscus rather than simply removing damaged tissue.
Patients interested in participating should note that the study has specific requirements regarding the extent of meniscal damage and the integrity of the remaining meniscal rim. The comprehensive evaluation process includes both patient-reported outcomes and objective imaging assessments, ensuring thorough monitoring of treatment results and safety.
