Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSven Behrendt

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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])

Trial design

Treatments tested in this trial

  • Spongioflex®
  • non-operated

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sven Behrendt

Lead sponsor

Privatpraxis für Knie- und Schulterchirurgie

Sponsor institution