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Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair

NCT02732873 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-10-12

No results posted yet for this study

Summary

The REKREATE project will be an international, multi-centre, non-randomised, prospective single-arm pivotal study. All study patients will receive the FibroFix™ Meniscus scaffold following the provision of informed consent. A study period of 1 year and extended follow up period of up to 3 years is planned , to enable a thorough and complete assessment of the performance of the device when implanted to replace removed or damaged meniscal tissue in humans. The test article for this multi-centre study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus.

Conditions

  • Repair of Meniscal Injury

Interventions

DEVICE

FibroFix Meniscal Scaffold

FibroFix™ Meniscus scaffold is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.

Sponsors & Collaborators

  • Southmead Hospital, Bristol, UK

    collaborator UNKNOWN

  • Magdeburg University Hospital, Germany

    collaborator UNKNOWN

  • Brandenburg University Hospital, Germany

    collaborator UNKNOWN

  • BundeswehrKrankenhaus Ulm, Germany

    collaborator UNKNOWN

  • Universitat Autonoma de Barcelona

    collaborator OTHER

  • Centre Hospitalier du Luxembourg

    collaborator OTHER

  • Orthox Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-01-31
Completion
2017-01-31

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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 NCT02732873 on ClinicalTrials.gov