Meniscus Lesion Clinical Trial
Official title:
Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss, an Investigator-initiated Low Interventional Trial.
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? - Can partial meniscal replacement prevent/postpone total meniscal replacement/knee prothesis? Researchers will compare the results of the operated group with patients not willing to be operated but with partial meniscal loss to see if the operation improves knee function. Participants will be operated and have to attend follow-up visits with MRI after 6 months up to 5 years after surgery.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | April 30, 2031 |
Est. primary completion date | April 30, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Patients (male and female) with: 2. Partial loss of portions of the - lateral meniscus and lateral joint line pain OR - medial meniscus and medial joint line pain 3. sufficient standing of the peripheral rim, so that the procedure can be performed 4. Age: 18-60 years 5. signed written informed consent to the study and to provide the scientific data in pseudonymized form Exclusion Criteria: 1. 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. 2. Axial deviation (>2° varus or valgus) 3. realignment osteotomy not performed within 12 weeks 4. advanced cartilage damage (grade III according to ICRS) and osteoarthrosis in the affected compartment (grade III according to Kellgren and Lawrence [33]) 5. Extension deficit of more than 3° compared to the opposite side or a knee flexion of less than 125° 6. inflammatory arthritis or synovitis on the treated knee 7. BMI greater than 30 kg/m² 8. <18 years, >60 years 9. Chronic pain patients 10. only for patients who will be operated: 1. with increased anaesthesiologic risk, e.g., with known or predicted difficult airway 2. with increased risk of bleeding 3. with increased risk of infection 4. with necrotic, infected, or poorly perfused host sides 5. history of allergic reactions 6. acute hypersensitivity reactions to the IMP or any of its excipients 7. pregnant woman |
Country | Name | City | State |
---|---|---|---|
Germany | Privatpraxis für Knie und Schulterchirurgie | Dortmund |
Lead Sponsor | Collaborator |
---|---|
Privatpraxis für Knie- und Schulterchirurgie |
Germany,
Behrendt S. MRI follow up of bilateral partial meniscal substitution with a demineralized bone block. A case report. Radiol Case Rep. 2022 Oct 27;18(1):21-26. doi: 10.1016/j.radcr.2022.09.091. eCollection 2023 Jan. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate efficacy of the procedure | Improvement of knee function after surgery compared to the non-operated group and compared to pre-surgery scores. | 5 years | |
Primary | Improvement of International Knee Documentation Committee (IKDC) score (between 0 and 100, the higher the better) | Improvement of IKDC Score after surgery compared to the non-operated group and compared to pre-surgery scores. | 5 years | |
Primary | Improvement of Knee Injury and Osteoarthritis Outcome Score (KOOS) score (between 0 and 100, the higher the better) | Improvement of KOOS score after surgery compared to the non-operated group and compared to pre-surgery scores. | 5 years | |
Primary | Improvement of Visual Analogue Scale (VAS) Pain Score (between 0 and 10, the lower the better) | Improvement of VAS Pain score after surgery compared to the non-operated group and compared to pre-surgery scores. | 5 years | |
Secondary | Safety of the patient (adverse events (AE) and serious adverse events (SAE)) | Type, frequency and severity of treatment-related AEs and SAEs | 5 years | |
Secondary | Efficacy of the procedure, progression to osteoarthrosis | How many patients show a progression of osteoarthrosis up to total knee arthroplasty (TKA)? | 5 years | |
Secondary | Menuiscus size | size of meniscus ((mm), depends on location, gender and height of patient), after 6 weeks, 6 and 12 months (for operated patients) and after 2 and 5 years, comparison between the operated and the non-operated group | 5 years | |
Secondary | extrusion of meniscus | extrusion of meniscus (yes/no, no extrusion is better) after 6 weeks, 6 and 12 months (for operated patients) and after 2 and 5 years, comparison between the operated and the non-operated group | 5 years | |
Secondary | Size of meniscal extrusion | Size of meniscal extrusion ((mm) the smaller the better) after 6 weeks, 6 and 12 months (for operated patients) and after 2 and 5 years, comparison between the operated and the non-operated group | 5 years | |
Secondary | Patient satisfaction | The scale of patient satifaction is: very pleased, pleased, not pleased, very unsatisfied in the operated group after 2 and 5 years, which will be asked in the questionnaire | 5 years |
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