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New treatment option for Meniscus Lesion
Official title Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
ClinicalTrials.gov ID: NCT06376422
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if partial meniscal replacement can prevent or postpone total meniscal replacement, in adult patients (female/male) with partial meniscal loss. The main questions it aims to answer are: Can partial meniscal replacement improve knee function?
- Time commitment: about 30 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Patients (male and female) with:
- Partial loss of portions of the
- lateral meniscus and lateral joint line pain OR
- medial meniscus and medial joint line pain
- sufficient standing of the peripheral rim, so that the procedure can be performed
You likely can't join if
- The presence of anterior cruciate ligament insufficiency which is not resolved by reconstruction of the anterior cruciate ligament within 16 weeks...
- Axial deviation (\>2° varus or valgus)
- realignment osteotomy not performed within 12 weeks
- advanced cartilage damage (grade III according to ICRS) and osteoarthrosis in the affected compartment (grade III according to Kellgren and Lawrence...
- Extension deficit of more than 3° compared to the opposite side or a knee flexion of less than 125°
- inflammatory arthritis or synovitis on the treated knee
See the full eligibility criteria
- Patients (male and female) with:
- Partial loss of portions of the
- lateral meniscus and lateral joint line pain OR
- medial meniscus and medial joint line pain
- sufficient standing of the peripheral rim, so that the procedure can be performed
- Age: 18-60 years
- signed written informed consent to the study and to provide the scientific data in pseudonymized form
- The presence of anterior cruciate ligament insufficiency which is not resolved by reconstruction of the anterior cruciate ligament within 16 weeks after partial meniscal implantation.
- Axial deviation (\>2° varus or valgus)
- realignment osteotomy not performed within 12 weeks
- advanced cartilage damage (grade III according to ICRS) and osteoarthrosis in the affected compartment (grade III according to Kellgren and Lawrence [33])
- Extension deficit of more than 3° compared to the opposite side or a knee flexion of less than 125°
- inflammatory arthritis or synovitis on the treated knee
- BMI greater than 30 kg/m²
- \ 60 years
- Chronic pain patients
- only for patients who will be operated:
- with increased anaesthesiologic risk, e.g., with known or predicted difficult airway
- with increased risk of bleeding
- with increased risk of infection
- with necrotic, infected, or poorly perfused host sides
- history of allergic reactions
- acute hypersensitivity reactions to the IMP or any of its excipients
- pregnant woman
The study team makes the final eligibility decision.
Where it's taking place
- Dortmund, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 30 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dortmund, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.