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

NCT06376422 | Recruiting

• 1 other identifier: EU-CT-2023-508271-36-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meniscus Lesion

Keywords

meniscus deficiency; partial meniscus replacement; Spongioflex®; Allograft; International Knee Documentation Committee (IKDC) Score; Knee Injury and Osteoarthritis Outcome Score (KOOS); Visuelle Analogskala (VAS) Score; Extrusion; magnetic resonance imaging (MRI)

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Safety of the patient (adverse events (AE) and serious adverse events (SAE))

  5 years

• Efficacy of the procedure, progression to osteoarthrosis

  5 years

• Menuiscus size

  5 years

• extrusion of meniscus

  5 years

• Size of meniscal extrusion

  5 years

Study Arms (2)

Spongioflex®

EXPERIMENTAL

As for any surgical procedure, the patient receives an antibiotic shot non-interventional medicinal product (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.

Procedure: Spongioflex®

non-operated

OTHER

no surgical treatment, no antibiotic shot, no visit at the end of the hospital stay, and no visit after 6 weeks. Follow-up visits after 6, 12 and 24 months and after 5 years.

Other: non-operated

Interventions

Spongioflex® PROCEDURE

partial meniscal replacment during surgery, follow-up visits at the end of hospital stay and after 6 weeks, MRI evaluation and questionnaires after 6, 12, 24 and 60 months.

Spongioflex®

non-operated OTHER

no surgery, MRI evaluation and questionnaires follow-up after 6, 12, 24 and 60 months

non-operated

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

• Sven Behrendt: lead

Study Sites (1)

Privatpraxis für Knie und Schulterchirurgie

Dortmund, 44137, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 36324835 BACKGROUND

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Sven Behrendt, MD

  Privatpraxis für Knie- und Schulterchirurgie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven Behrendt, MD

CONTACT

+49231 8626064; praxis@dr-sven-behrendt.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: no masking, patient decides which group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 19, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2031
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)