search
Back to results

Neocartilage Implant to Treat Cartilage Lesions of the Knee

Primary Purpose

Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)
Microfracture
Sponsored by
ISTO Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Articular Cartilage Disorder focused on measuring cartilage, knee surgery, cartilage injury, knee pain, cartilage repair, cartilage damage, cartilage lesion, cartilage defect, articular cartilage lesion, articular cartilage defect, juvenile, cells, ISTO Technologies, Neocartilage, RevaFlex

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Generally, the following inclusion criteria must be met, however, this is not a complete list.

  • Male or Female between the ages of 18 and 60
  • (1) or (2) articular cartilage lesions of the distal femur ranging in no more than 5 cm2 each
  • Ipsilateral knee compartment has intact menisci (or meniscectomized remnant with > 5mm wide rim) and stable ligaments in the affected knee
  • 3 months out from initiation of conservative non-surgical management (e.g.hyaluronic acid injection, activity modification) or previous minimal surgical intervention (e.g., arthroscopic lavage, debridement) or 12 months out from marrow stimulation for this condition

Exclusion Criteria:

Generally, if a potential participant meets any of the following criterions, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.

  • Osteoarthritis
  • Rheumatoid arthritis
  • History of septic or reactive arthritis
  • Gout or a history of gout or pseudo-gout in the affected knee
  • Osteochondritis dissecans or osteochondral lesions of the knee with bone loss > 6mm deep
  • Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface)
  • Associated damage to the underlying subchondral bone requiring an osteochondral graft
  • Is pregnant or breast-feeding
  • Has a BMI > 35 (kg/m2)
  • Has prior total meniscectomy of either knee
  • Has received, within the past three months, intra-articular hyaluronic acid therapy, or steroid therapy
  • Has more than two clinically relevant chondral lesion(s) on the index knee

Sites / Locations

  • Kerlan Jobe Orthopaedic Clinic
  • Santa Monica Orthopaedic & Sports Medicine Group
  • Rush University Medical Center
  • Hospital for Special Surgery -Sports Medicine and Shoulder Service
  • Insall Scott Kelly Institute for Orthopaedics & Sports Medicine
  • Cleveland Clinic
  • The Ohio State University Sports Medicine Center
  • The Hawkins Foundation
  • The Methodist Hospital Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Neocartilage Implant

Microfracture

Arm Description

Neocartilage Implant surgically implanted and affixed to subchondral bone using commercial fibrin during mini-open knee arthrotomy.

Standard of care cartilage repair technique.

Outcomes

Primary Outcome Measures

Knee Injury and Osteoarthritis Outcomes Scores (KOOS)
Knee Injury and Osteoarthritis Outcomes Scores (KOOS) Pain and Function in Daily Living (ADL) subscales.

Secondary Outcome Measures

IKDC Knee Examination
Subject reported questionnaires
Various questionnaires are required to be completed by the subject before and after treatment throughout the study.

Full Information

First Posted
July 20, 2011
Last Updated
August 29, 2017
Sponsor
ISTO Technologies, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01400607
Brief Title
Neocartilage Implant to Treat Cartilage Lesions of the Knee
Official Title
Randomized Controlled Trial to Evaluate the Efficacy of a Neocartilage Implant in the Management of ICRS Grade 3 to 4 Articular Cartilage Lesions of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ISTO Technologies, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment.
Detailed Description
In the United States alone, more than 500,000 cartilage lesions per year require some treatment to reduce pain, restore joint mobility, and prevent further damage caused by the progression of osteoarthritis. The lack of effective cartilage repair approaches or products for restoration of defective articular cartilage to its native, hyaline morphology only continues to exacerbate the incidence of osteoarthritis as these initial defects enlarge and degrade over a 10 to 20 year period. The repair of cartilage, especially in the knee, remains a formidable clinical challenge. Regenerative medicine approaches to cartilage repair have only begun to be explored as possible options and there is a clear trend toward biological solutions for the repair and regeneration of damaged or diseased articular cartilage. The study was designed to compare how well the Neocartilage Implant works against the microfracture therapy, a widely used and accepted cartilage repair therapy. Data to be collected include Pain and Function in Daily Living scores, symptoms, Function in Sports and Recreation, and Knee Related Quality of Life. Additionally, MRI and X-rays will be collected to evaluate the cartilage repair progress. These assessments will be used through the five years of post-operative follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury, Acute Cartilage Injury, Defect of Articular Cartilage
Keywords
cartilage, knee surgery, cartilage injury, knee pain, cartilage repair, cartilage damage, cartilage lesion, cartilage defect, articular cartilage lesion, articular cartilage defect, juvenile, cells, ISTO Technologies, Neocartilage, RevaFlex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neocartilage Implant
Arm Type
Active Comparator
Arm Description
Neocartilage Implant surgically implanted and affixed to subchondral bone using commercial fibrin during mini-open knee arthrotomy.
Arm Title
Microfracture
Arm Type
Other
Arm Description
Standard of care cartilage repair technique.
Intervention Type
Biological
Intervention Name(s)
Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)
Other Intervention Name(s)
RevaFlex
Intervention Description
The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.
Intervention Type
Other
Intervention Name(s)
Microfracture
Other Intervention Name(s)
marrow stimulation
Intervention Description
Marrow stimulation using the microfracture technique; performed arthroscopically
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcomes Scores (KOOS)
Description
Knee Injury and Osteoarthritis Outcomes Scores (KOOS) Pain and Function in Daily Living (ADL) subscales.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
IKDC Knee Examination
Time Frame
Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years
Title
Subject reported questionnaires
Description
Various questionnaires are required to be completed by the subject before and after treatment throughout the study.
Time Frame
Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Generally, the following inclusion criteria must be met, however, this is not a complete list. Male or Female between the ages of 18 and 60 (1) or (2) articular cartilage lesions of the distal femur ranging in no more than 5 cm2 each Ipsilateral knee compartment has intact menisci (or meniscectomized remnant with > 5mm wide rim) and stable ligaments in the affected knee 3 months out from initiation of conservative non-surgical management (e.g.hyaluronic acid injection, activity modification) or previous minimal surgical intervention (e.g., arthroscopic lavage, debridement) or 12 months out from marrow stimulation for this condition Exclusion Criteria: Generally, if a potential participant meets any of the following criterions, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria. Osteoarthritis Rheumatoid arthritis History of septic or reactive arthritis Gout or a history of gout or pseudo-gout in the affected knee Osteochondritis dissecans or osteochondral lesions of the knee with bone loss > 6mm deep Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface) Associated damage to the underlying subchondral bone requiring an osteochondral graft Is pregnant or breast-feeding Has a BMI > 35 (kg/m2) Has prior total meniscectomy of either knee Has received, within the past three months, intra-articular hyaluronic acid therapy, or steroid therapy Has more than two clinically relevant chondral lesion(s) on the index knee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michaela Purcell
Organizational Affiliation
ISTO Technologies, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kerlan Jobe Orthopaedic Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Santa Monica Orthopaedic & Sports Medicine Group
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Hospital for Special Surgery -Sports Medicine and Shoulder Service
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Insall Scott Kelly Institute for Orthopaedics & Sports Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Sports Medicine Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
The Hawkins Foundation
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Neocartilage Implant to Treat Cartilage Lesions of the Knee

We'll reach out to this number within 24 hrs