Sterile allogeneic spongioflex® allografts as partial meniscal replacement after incomplete meniscal loss, an investigator initiated trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dr. Sven Behrendt, Knie und Schulterchirurgie

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Trial duration

30 Apr 2024 → ongoing

Decision date (initial)

2024-03-15

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Dr. Behrendt, Praxis für Knie- und Schulterchirurgie

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

The objective is to improve the meniscus functionality. The efficacy of the procedure will be evalated using the PROMS (IKDC, KOOS, VAS-pain-score). The comparison of the PROMs between patients operated and not operated will be performed and a comparison between PROMs at the beginning of the study and after 2 and 5 years. The clinical trial will be conducted in compliance with the protocol, the CTR 536/2014 and with this Regulation and with the principles of good clinical practice.

Secondary objectives 4

1. Safety of the patient will be estimated by Type, frequency, and severity of treatment related to AEs and SAEs
2. Efficacy of the procedure will be evaluated by answering the question: How many patients show a progression of osteoarthrosis up to TKA?
3. MRI evaluation will be performed by Outerbridge graduation, size of meniscus, number of patients with extrusion, size of extrusion 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
4. patient satisfaction using the satisfaction categories: very pleased, pleased, not pleased, very unsatisfied in the operated group after 2 and 5 years will be analyzed..

Conditions and MedDRA coding

incomplete meniscal loss

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Partial loss of portions of the lateral meniscus and lateral joint line pain OR - Partial loss of the medial meniscus and medial joint line pain
2. Age 18-60 years
3. written consent to the study and to provide the scientific data in pseudonymized form
4. sufficient standing of the peripheral rim, so that the procedure can be performed

Exclusion criteria 11

1. Presence of anterior cruciate ligament insufficiency that is not resolved by reconstruction of the anterior cruciate ligament within 16 weeks after partial meniscal implantation.
2. only for patients who will be operated: - with increased anesthesiological 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 or acute hypersensitivity reactions to the IMP or any of its excipients - pregnant woman
3. Axial deviation (>2° varus or valgus)
4. realignment osteotomy not performed within 12 weeks
5. advanced cartilage damage (grade III according to ICRS) and osteoarthrosis in the affected compartment (grade III according to Kellgren and Lawrence (Kellgren and Lawrence, 1957)
6. Extension deficit of more than 3° compared to the opposite side or a knee flexion of less than 125°
7. BMI greater than 30 kg/m²
8. <18 years, >60 years
9. pregnancy (only for patients with surgery)
10. Chronic pain patients
11. inflammatory arthritis or synovitis on the treated knee

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Improvement of PROMs (KOOS, IKDC, VAS Pain Score) 2 and 5 years after surgery compared to scores of the non-operated group and compared to pre-surgery scores.

Secondary endpoints 4

1. Safety of the patient: Type, frequency and severity of treatment-related AEs and SAEs
2. Efficacy of the procedure: How many patients show a progression of osteoarthrosis up to TKA?
3. MRI evaluation: Outerbridge graduation, size of meniscus, number of patients with extrusion, size of extrusion 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
4. Patient satisfaction: very pleased, pleased, not pleased, very unsatisfied in the operated group after 2 and 5 years

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dr. Sven Behrendt, Knie und Schulterchirurgie

Sponsor organisation

Dr. Sven Behrendt, Knie und Schulterchirurgie

Address

Hoher Wall 14, Mitte Mitte

City

Dortmund

Postcode

44137

Country

Germany

Scientific contact point

Organisation

Dr. Sven Behrendt, Praxis für Kien und Schulterchirurgie

Contact name

Dr. Sven Behrendt, Praxis für Knie- und Schulterchirugie

Public contact point

Organisation

Dr. Sven Behrendt, Praxis für Kien und Schulterchirurgie

Contact name

Dr. Sven Behrendt, Praxis für Knie- und Schulterchirugie

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications