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Partial Meniscal Replacement with Spongioflex®

NCT06775197 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-15

No results posted yet for this study

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

Interventions

PROCEDURE

partial meniscal replacement with Spongioflex®

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.

Sponsors & Collaborators

  • Maria-Josef-Hospital Greven

    lead OTHER

Principal Investigators

  • Clemens Kösters, PD, Dr. med · Maria-Josef-Hospital Greven GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2029-11-05
Completion
2031-11-05

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06775197 on ClinicalTrials.gov