NCT00548119

Brief Summary

The objective of this study is to gather additional information regarding the performance of NeoCart to fill articular cartilage defects in the knee.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 21, 2014

Status Verified

March 1, 2014

Enrollment Period

2.9 years

First QC Date

October 19, 2007

Last Update Submit

March 25, 2014

Conditions

Articular Cartilage Damage

Outcome Measures

Primary Outcomes (1)

  • The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy.

    One year

Secondary Outcomes (1)

  • This study will extend the experience derived from our Phase 1 study.

    One year

Study Arms (2)

NeoCart

EXPERIMENTAL
Biological: NeoCart

microfracture

ACTIVE COMPARATOR
Procedure: microfracture

Interventions

NeoCartBIOLOGICAL

autologous tissue implant

NeoCart
microfracturePROCEDURE

microfracture

microfracture

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients presenting with symptomatic knee pain indicative of an articular cartilage injury and able and willing to give informed consent.

You may not qualify if:

  • Patients with any previous surgical treatment other than debridement or microfracture of the study cartilage defect.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCSF

San Francisco, California, 94143, United States

Location

TRIA Orthopedic Center

Bloomington, Minnesota, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Keller Army Community Hospital

West Point, New York, United States

Location

Duke Sports Medicine Center

Durham, North Carolina, 27710, United States

Location

OHSU

Portland, Oregon, United States

Location

Related Publications (1)

  • Anderson DE, Williams RJ 3rd, DeBerardino TM, Taylor DC, Ma CB, Kane MS, Crawford DC. Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries. Am J Sports Med. 2017 Mar;45(4):875-883. doi: 10.1177/0363546516677255. Epub 2017 Jan 9.

    PMID: 28068480DERIVED

MeSH Terms

Interventions

Arthroplasty, Subchondral

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2007

First Posted

October 23, 2007

Study Start

December 1, 2006

Primary Completion

November 1, 2009

Study Completion

March 1, 2014

Last Updated

April 21, 2014

Record last verified: 2014-03

Locations

US(6)