What is Spongioflexae studying for partial meniscal loss?

Spongioflexae is being studied as a new biological implant to replace damaged parts of the meniscus in the knee. Researchers aim to see if it can restore meniscus function and delay the need for knee replacement surgery. This investigator-initiated trial is led by Maria-Josef-Hospital Greven to evaluate its potential benefits and safety.

Who may be eligible for this partial meniscal loss clinical trial?

Adults aged 18 to 60 years with partial loss of the medial or lateral meniscus causing knee pain may be eligible. Both men and women can participate. Important factors include knee stability without significant misalignment and a BMI of 30 or less. Please review eligibility criteria for more details.

Is there any cost to participate in this partial meniscal loss clinical trial?

Study-related care, including the surgical implant and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for their visit costs.

Actively Recruiting

Phase 4

Age: 18Years - 60Years

All Genders

ID06775197

Study of Partial Meniscal Replacement Using Spongioflexae Allograft for Adults Aged 18 to 60 with Partial Meniscal Loss

Led by Maria-Josef-Hospital Greven · Updated on 2025-01-15

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

This research investigates the use of a novel biological graft, Spongioflexae, for partial meniscal replacement in patients with symptomatic, degenerative, and irreparable damage to the medial or lateral meniscus. The study aims to assess whether this new implant can avoid or delay the disadvantages associated with previous replacement materials and reduce the need for total knee arthroplasty TKA. Since no current alternative biological material exists, this trial holds significant medical and economic importance. Previous research shows that successful meniscal repair improves clinical knee function and MRI imaging outcomes. Participants who choose surgery will receive the Spongioflexae implant during an arthroscopic procedure, where a demineralized allogenic bone block is fitted to the meniscal defect and secured with sutures. Surgery lasts 60 to 90 minutes with a hospital stay of 2 to 3 days. Patients who opt not to have surgery will be closely monitored and may join the operated group later. Follow-up visits occur at hospital discharge, 6 weeks, 6, 12, 24 months, and 5 years after implantation. Throughout the study, participants undergo evaluations including MRI scans to assess meniscal size, extrusion, and cartilage condition, as well as clinical knee scores like KOOS, IKDC, and VAS pain measured at multiple time points. Safety is monitored by recording adverse events. Patient satisfaction questionnaires are also completed. The research team tracks the procedures effectiveness in preventing or delaying the progression to knee replacement, with total participation lasting up to 5 years.

CONDITIONS

Brief Title

Partial Meniscal Replacement with Spongioflex®

Who Can Participate

Age: 18Years - 60Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients with partial loss of the lateral meniscus with lateral joint line pain or medial meniscus with medial joint line pain
Sufficient standing of the peripheral rim to allow the procedure
Age between 18 and 60 years
Signed written informed consent to participate and provide pseudonymized scientific data
Both male and female patients

You will not qualify if you...

Anterior cruciate ligament insufficiency not corrected by reconstruction within 16 weeks after meniscal implantation
Axial deviation greater than 2° varus or valgus
Realignment osteotomy not done within 12 weeks
Advanced cartilage damage (grade III) or osteoarthritis in the affected compartment
Extension deficit over 3° compared to opposite side or knee flexion less than 125°
Inflammatory arthritis or synovitis in the treated knee
Body mass index over 30 kg/m²
Age under 18 or over 60 years
Chronic pain patients
For operated patients: increased anesthetic risk, bleeding or infection risk, necrotic or poorly perfused host tissue, history of allergic or acute hypersensitivity reactions to the implant or its components
Pregnant women

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay of 2 to 3 days

Participants undergo arthroscopic partial meniscal replacement with Spongioflex® implant to restore meniscus function. Surgery lasts 60 to 90 minutes and includes antibiotic prophylaxis before the procedure. Participants stay in the hospital for 2 to 3 days after surgery for immediate post-operative care.

1 surgery visit and hospital stay

Post-operative Follow-up

Duration - Up to 5 years

Participants attend follow-up visits to monitor recovery, evaluate knee function, pain, and implant integration using clinical scores and MRI. Follow-up includes visits at the end of hospital stay, 6 weeks, 6 months, 12 months, 24 months, and 5 years after surgery.

Approximately 6 post-operative visits

Long-term Monitoring

Duration - Up to 5 years

Participants who opted not to undergo surgery are closely monitored over time to assess knee condition and may join the operated group later.

Visits at 6 weeks, 6 months, 12 months, 24 months, and 5 years