OHSU

IRB #

IRB00006045

Title

A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee

Principal Investigator

Dennis Crawford

Study Purpose

NeoCart is a new biological tissue implant designed to repair damaged articular cartilage of the knee in patients without osteoarthritis. NeoCart is produced from a small amount of your own healthy articular cartilage. The purpose of this study is to compare the safety and efficacy of NeoCart and standard Microfracture surgical techniques for the treatment of articular cartilage injury. Participants are randomly assigned to either NeoCart (2/3 chance) or Microfracture (1/3 chance) treatment groups. Evaluations include questionnaires, physical evaluations, laboratory tests, X rays, and MRI.

Medical Condition(s)

Articular cartilage damage in patients without osteoarthritis.

Eligibility Criteria

Eligible participants:
1. Are between 18 and 55 years of age
2. Have full-thickness articular cartilage damage to the weight bearing surface of the femoral condyle(s).
3. Must not have subcondral bone damage
4. Must not have previous Microfracture or other cartilage treatment (except debridement)
5. Must not be pregnant or intending to be pregnant for 12 months post study surgery
6. Must be able to have MRI
Please consult Study Coordinator for full eligibility criteria.

Age Range

18 years - 55 years

Healthy Volunteers Needed

No

Duration of Participation

Three years

Minors Included

No

Contact

Hannah Jones
503-418-8678
rainesh@ohsu.edu
or
Samantha Quilici, PA-C
503-494-4000
quilicis@ohsu.edu

Sponsor

Histogenics Corporation

Recruitment End

12/31/2014

Compensation Provided

Yes

Compensation

Subjects will be provided a convenience fee of $25.00 for each of the 10 day, 6 weeks, 3, 6, 12, 24, and 36 months doctor visits to support the cost of parking/travel (up to a total of $175.00 for office visits). Subjects will also be provided a convenience fee of $25.00 for each of the 6, 12, 24 and 36 month MRI visits (up to $100.00 total for MRI visits). The maximum total compensation a subject may receive during their participation in this study is $275.00.


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