Neocartilage Implant to Treat Cartilage Lesions of the Knee

NCT01400607 | Terminated Phase 3 DMC

• 1 other identifier: ISTO NEO-01-09-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcomes Scores (KOOS)

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

  36 months

Secondary Outcomes (2)

• IKDC Knee Examination

  Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years

• Subject reported questionnaires

  Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years

Study Arms (2)

Neocartilage Implant

ACTIVE COMPARATOR

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

Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)

Microfracture

OTHER

Standard of care cartilage repair technique.

Other: Microfracture

Interventions

Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft) BIOLOGICAL

The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.

Also known as: RevaFlex

Neocartilage Implant

Microfracture OTHER

Marrow stimulation using the microfracture technique; performed arthroscopically

Also known as: marrow stimulation

Microfracture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ISTO Technologies, Inc.: lead

Study Sites (9)

Kerlan Jobe Orthopaedic Clinic

Los Angeles, California, 90045, United States

Location

Santa Monica Orthopaedic & Sports Medicine Group

Santa Monica, California, 90404, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Hospital for Special Surgery -Sports Medicine and Shoulder Service

New York, New York, 10021, United States

Location

Insall Scott Kelly Institute for Orthopaedics & Sports Medicine

New York, New York, 10065, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Sports Medicine Center

Columbus, Ohio, 43221, United States

Location

The Hawkins Foundation

Greenville, South Carolina, 29615, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Arthroplasty, Subchondral

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Michaela Purcell

  ISTO Technologies, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 31, 2017

Record last verified: 2016-09

Locations

US (9)