Partial Meniscal Replacement with Spongioflex®

NCT06775197 | Recruiting Phase 4

• 1 other identifier: Spongioflex_EK_5324_01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigator-initiated trial is to evaluate whether the novel graft can prevent/reduce the disadvantages of the previously used replacement materials and shows better results than the group of patients, which were not operated. Since there is currently no alternative made of biological material to this product, this investigator-initiated trial is of great medical and economic importance. The otherwise following arthrosis or knee prosthesis implantation (TKA ) could be prevented or at least postponed. Initial clinical results are promising. An important and sensitive parameter for assessing the postoperative function of the meniscus is the MRI image. Genovese et al. 2007 were able to show in a categorization/classification which magnetic resonance image can be expected in the case of successful incorporation. Several studies have shown that the known clinical knee scores (Lysholm, IKDC, KOOS, VAS pain) improve significantly after successful ingrowth of the meniscus implant.

Conditions

Partial Meniscal Loss; Lateral Meniscus Partial Loss; Medial Meniscal Partial Loss; Meniscus Lesion; Meniscal Injuries; Meniscal Tear

Keywords

partial meniscal loss; Allograft; Spongioflex®; IKDC; KOOS; return to sport; Outerbridge score; extrusion; VAS pain score

Outcome Measures

Primary Outcomes (3)

• To evaluate efficacy of the procedure using the KOOS Score

  Improvement of KOOS 2 and 5 years after surgery compared to scores of the non-operated group and compared to pre-surgery scores

  at 6 weeks, 6 and 12 months (operated patients) and at 2 years and 5 years

• To evaluate efficacy of the procedure using the IKDC

  Improvement of IKDC 2 and 5 years after surgery compared to scores of the non-operated group and compared to pre-surgery scores

  at 6 weeks, 6 and 12 months (operated patients) and at 2 years and 5 years

• To evaluate efficacy of the procedure using the VAS pain Score

  Improvement of VAS pain Score 2 and 5 years after surgery compared to scores of the non-operated group and compared to pre-surgery scores

  at 6 weeks, 6 and 12 months (operated patients) and at 2 years and 5 years

Secondary Outcomes (7)

• Safety of the patient using the number of adverse events an serious adverse events

  at 6 weeks, 6 and 12 months (for operated patients) and at 2 and 5 years

• Efficacy of the procedure to prevent/prolonge progression to TKA

  at 6 weeks, 6 and 12 months (for operated patients) and at 2 and 5 years

• MRI evaluation using outerbridge graduation

  at 6 weeks, 6 and 12 months (for operated patients) and at 2 and 5 years

• MRI evaluation for size of meniscus

  at 6 weeks, 6 and 12 months (for operated patients) and at 2 and 5 years

• MRI evaluation for number of patients with extrusion

  at 6 weeks, 6 and 12 months (for operated patients) and at 2 and 5 years

Study Arms (2)

operated group (partial meniscal replacement)

ACTIVE COMPARATOR

Patients, who decide to get operated will be in the experimental group, Spongioflex® will be the investigational product

Procedure: partial meniscal replacement with Spongioflex®

non-operated patients

NO INTERVENTION

Patients who do not decide to be operated at this stage, but want to be closely monitored to eventually join the operated group later.

Interventions

partial meniscal replacement with Spongioflex® PROCEDURE

for any surgical procedure, the patient receives an antibiotic shot NIMP) just before surgery. The patient will be arthroscopically treated via the arthroscopic portal with implantation of a demineralized bone block (IMP: Spongioflex ®, appropriate size (DIZG gGmbH, Berlin, Germany)) as a partial meniscus substitute. The block will be adapted to the defect size and secured with 2-4 inside-out sutures (Etibond 0, Ethicon, Somerville, NJ). No dosing, the IMP has no systemic effect. The surgery (Intervention) will last between 60-90 minutes. The hospital stay is between 2-3 days after surgery. Follow-up visits: at the end of the hospital stay, after 6 weeks, after 6, 12 and 24 months and after 5 years for the operated group.

operated group (partial meniscal replacement)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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
• Age: 18-60 years
• signed written informed consent to the study and to provide the scientific data in pseudonymized form

You may not qualify if:

• 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
• \<18 years, \>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

Sponsors & Collaborators

• Maria-Josef-Hospital Greven: lead

Study Sites (1)

Maria-Josef-Hospital Greven GmbH

Greven, North Rhine-Westphalia, 48268, Germany

RECRUITING

Related Publications (30)

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Study Officials

• Clemens Kösters, PD, Dr. med

  Maria-Josef-Hospital Greven GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clemens Kösters, PD, Dr. med.

CONTACT

+49-2571-502-12001; Clemens.Koesters@mjh-greven.de

Daniel A den Toom, Dr. med

CONTACT

+49-2571-502-12001; daniel.toom@mhj-greven.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: non
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Low interventional trial with 2 arms (operated group in comparison to non-operated group)

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 15, 2025
• Study Start: November 5, 2024
• Primary Completion (Estimated): November 5, 2029
• Study Completion (Estimated): November 5, 2031
• Last Updated: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)