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Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee

NCT04537013 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-02-13

No results posted yet for this study

Summary

Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.

Conditions

  • Knee Injuries
  • Cartilage Injury
  • Cartilage Disease
  • Knee Discomfort

Interventions

PROCEDURE

Microfracture

Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells.

DEVICE

Microfracture plus placement of Chondro-Gide® ACC

Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells, followed by affixing Chondro-Gide® with fibrin glue.

Sponsors & Collaborators

  • Geistlich Pharma AG

    lead INDUSTRY

Principal Investigators

  • Fabiana Martinelli · Geistlich Pharma AG

  • Kevin Plancher, MD · Plancher Orthopedics and Sports Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-26
Primary Completion
2025-09-25
Completion
2025-09-29
FDA Device
Yes

Countries

  • United States
  • Canada
  • 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 NCT04537013 on ClinicalTrials.gov