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NCT01957722 · ClinicalTrials.gov registry record · Phase 3

NOVOCART®3D for Treatment of Articular Cartilage of the Knee

A Phase 3 study of Articular Cartilage of the Femoral Condyle Between 2-6cm2, sponsored by Aesculap Biologics.

Active
Registry status
Phase 3
Development phase
233
Enrollment target
20
Study locations

NCT01957722: Active Phase 3 study of Articular Cartilage of the Femoral Condyle Between 2-6cm2, sponsored by Aesculap Biologics.

NCT01957722 is a Phase 3 study of Articular Cartilage of the Femoral Condyle Between 2-6cm2 that is active but no longer recruiting, run by Aesculap Biologics. The registered enrollment target is 233 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01957722, a Phase 3 study of Articular Cartilage of the Femoral Condyle Between 2-6cm2, is active but no longer recruiting, sponsored by Aesculap Biologics.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
233 participants
Enrollment target
20
Study locations

Study Summary

This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.

Primary Outcome

As measured by a change in KOOS (pain subdomain) score at 24 months from baseline

Interventions

  • PROCEDURE Microfracture
  • BIOLOGICAL NOVOCART 3D

Study Locations (20)

California

  • Grossmont Orthopaedic Medical Group - La Mesa
  • UCLA - Los Angeles
  • Stanford Medicine - Redwood City

New York

  • Mount Sinai Faculty Practice Associates - New York
  • Plancher Orthopaedics & Sports Medicine - New York
  • Long Island Bone and Joint Llp - Port Jefferson

Colorado

  • Cu Sports Medicine - Denver
  • Yampa Valley Medical Center - Steamboat Springs

Florida

  • Tenet Florida Physician Services - Boca Raton
  • Paley Orthopedic and Spine Institute - West Palm Beach

Illinois

  • Rush University Medical Center - Chicago
  • Northshore University Health System - Evanston

Minnesota

  • Tria Orthopaedic Center - Bloomington
  • Mayo Clinic - Rochester

Idaho

  • Saint Alphonsus Medical Group - Meridian

Kentucky

  • University of Kentucky - Lexington

Trial Details

FieldValue
Enrollment Target 233 participants
Start Date 2013-12
Est. Completion 2027-12
Phase Phase 3
Aesculap Biologics

2 total trials

What the registry record for NCT01957722 still lists

NCT01957722 is an interventional study that assigns participants to a tested intervention. The registered 233 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).

The record links to 1 condition, with Articular Cartilage of the Femoral Condyle Between 2-6cm2 appearing as the primary indexed condition, and to 2 interventions - of which Microfracture is the first listed.

NCT01957722 names 20 study sites across 12 states, led by California, New York, Colorado.

Frequently Asked Questions

What is clinical trial NCT01957722 about?

NCT01957722 is a clinical study titled "NOVOCART®3D for Treatment of Articular Cartilage of the Knee". This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.

What is the current status of trial NCT01957722?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 233 participants. The study started on 2013-12. Estimated completion is 2027-12.

What conditions does trial NCT01957722 study?

This clinical trial studies the following conditions: Articular Cartilage of the Femoral Condyle Between 2-6cm2.

What interventions are being tested in trial NCT01957722?

The interventions under investigation include: Microfracture (PROCEDURE), NOVOCART 3D (BIOLOGICAL).

Who is sponsoring clinical trial NCT01957722?

This trial is sponsored by Aesculap Biologics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01957722 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01957722's enrollment target sits among peer trials

233 1298th of 2000 higher than 703 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01957722, the US trial registry maintained by the National Library of Medicine. NCT01957722 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.