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Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects

NCT03262909 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2022-03-22

No results posted yet for this study

Summary

Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a historical control arm (microfracture) in the treatment of cartilage defects in the knee.

Conditions

  • Articular Cartilage Defects in the Knee Joint

Interventions

DEVICE

GelrinC

Patients will undergo GelrinC implantation.

OTHER

Microfracture historical control arm

Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.

Sponsors & Collaborators

  • Regentis Biomaterials

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2023-04-30
Completion
2024-11-30
FDA Device
Yes

Countries

  • United States

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 NCT03262909 on ClinicalTrials.gov