Back to resultsClinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee (SECURE)
Primary Purpose
Knee Injuries, Cartilage Injury, Cartilage Disease
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Microfracture
Microfracture plus placement of Chondro-Gide® ACC
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries focused on measuring Microfracture, Cartilage, Knee
Eligibility Criteria
Inclusion Criteria:
- Signed written informed consent
- One symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified MRI or arthroscopy
- Between 18 and 55 years of age
- Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, and the rehabilitation protocol
Exclusion Criteria:
- BMI ≥ 30 kg/m2
- Symptomatic contralateral knee
- Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more
- Prior surgical treatment of the cartilage using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to enrollment)
- Patella dysplasia
- Chronic inflammatory arthritis or infectious arthritis
- History of autoimmune disease or immunodeficiency
- History of connective tissue disease
- Intra-articular steroid use within the 3 months prior to enrollment
- Other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment
- The patient is currently being treated with radiation, chemotherapy, immunosuppression or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone
- Pregnancy or lack of adequate contraceptives if a female of child-bearing potential
- Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study
- Active infection of the index knee
- Previous diagnosis of osteoporosis as diagnosed by DEXA, bone densitometry or CT scan
- Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
- History or current substance or alcohol abuse as defined by the DSM-V
- Any other medical condition that the investigator determines would interfere with the validity of the study
- Known allergy to porcine collagen
- Symptom duration greater than 36 months
Sites / Locations
- The MORE FoundationRecruiting
- CORE Orthopaedic Medical CenterRecruiting
- Emory University School of MedicineRecruiting
- MedStar Orthopaedics InstituteRecruiting
- Plancher Orthopedics and Sports MedicineRecruiting
- Fraser Orthopaedic InstituteRecruiting
- St. Joseph's Healthcare HamiltonRecruiting
- Martin Luther KrankenhausRecruiting
- Universitätsklinikum Schleswig Holstein Campus LübeckRecruiting
- Orthopädische Chirurgie München
- Sportklinik RavensburgRecruiting
- University Hospital RegensburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Arm
Investigational Group
Arm Description
Patients with small chondral lesions of the knee
Patients with large chondral lesions of the knee
Outcomes
Primary Outcome Measures
Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS
The CCS is defined as a patient meeting all of the three following criteria:
Improvement in the Pain sub-scale of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) between baseline to 24 months follow-up
Improvement in function, defined as an improvement in the International Knee Documentation Committee (IKDC) score between baseline to 24 months follow-up
Freedom from device- or procedure-related serious adverse events (SAEs) or secondary surgical intervention related to the device, procedure, or treated lesion
Secondary Outcome Measures
Knee Injury and Osteoarthritis Outcome Score
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. Calculate the mean score of the individual items of each subscale and divide by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems.
Magnetic Resonance Observation of Cartilage Score
Magnetic Resonance Image (MRI) will be obtain during the course of the study at 3 months, 12 months, and 24 months. MOCART 2.0 scoring will occur by independent assessment using the MOCART score. The score is a 9-part and 29-item scoring system, also resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represent the worst imaginable score, 100 points represent the best imaginable score.
Patient satisfaction
Were you satisfied with the procedure? (Satisfied, Somewhat satisfied, Neutral, Somewhat unsatisfied, Unsatisfied)
Would you have this procedure again if needed on the other knee? (Definitely yes, Probably yes, Not Sure, Probably Not, Definitely Not)
Tegner Activity Scale
The Tegner activity score is a one-item score that grades activity based on work and sports activities. Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. A scale of the highest level activity being 10 and the lowest being 0
Employment status
Employment status will be collected as: Employed full-time, Employed part-time, Not employed due to knee problems, Not employed due to reasons other than knee problems.
EuroQol-5 Dimension (EQ-5D)
The EQ-5D measures as a descriptive system comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04537013
Brief Title
Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee
Acronym
SECURE
Official Title
A ProSpective, MulticEnter, Concurrently Controlled Clinical Study of Chondro-Gide® ArticUlar Cartilage CoveR for the Treatment of Large Chondral Lesions in the KnEe (SECURE)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geistlich Pharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.
Detailed Description
The study evaluates the investigational treatment for treating large chondral lesions of the knee to the control treatment of microfracture alone for treating small lesions.Eligible patients with a large lesion will be treated with microfracture plus the Chondro-Gide® ACC and compared to patients with small lesions that are treated with microfracture alone. Outcome measures to be assessed include patient reported outcomes and freedom from certain adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries, Cartilage Injury, Cartilage Disease, Knee Discomfort
Keywords
Microfracture, Cartilage, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
234 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Patients with small chondral lesions of the knee
Arm Title
Investigational Group
Arm Type
Experimental
Arm Description
Patients with large chondral lesions of the knee
Intervention Type
Procedure
Intervention Name(s)
Microfracture
Intervention Description
Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells.
Intervention Type
Device
Intervention Name(s)
Microfracture plus placement of Chondro-Gide® ACC
Intervention Description
Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells, followed by affixing Chondro-Gide® with fibrin glue.
Primary Outcome Measure Information:
Title
Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS
Description
The CCS is defined as a patient meeting all of the three following criteria:
Improvement in the Pain sub-scale of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) between baseline to 24 months follow-up
Improvement in function, defined as an improvement in the International Knee Documentation Committee (IKDC) score between baseline to 24 months follow-up
Freedom from device- or procedure-related serious adverse events (SAEs) or secondary surgical intervention related to the device, procedure, or treated lesion
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score
Description
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. Calculate the mean score of the individual items of each subscale and divide by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems.
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Title
Magnetic Resonance Observation of Cartilage Score
Description
Magnetic Resonance Image (MRI) will be obtain during the course of the study at 3 months, 12 months, and 24 months. MOCART 2.0 scoring will occur by independent assessment using the MOCART score. The score is a 9-part and 29-item scoring system, also resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represent the worst imaginable score, 100 points represent the best imaginable score.
Time Frame
3 months, 12 months, and 24 months
Title
Patient satisfaction
Description
Were you satisfied with the procedure? (Satisfied, Somewhat satisfied, Neutral, Somewhat unsatisfied, Unsatisfied)
Would you have this procedure again if needed on the other knee? (Definitely yes, Probably yes, Not Sure, Probably Not, Definitely Not)
Time Frame
6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Title
Tegner Activity Scale
Description
The Tegner activity score is a one-item score that grades activity based on work and sports activities. Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. A scale of the highest level activity being 10 and the lowest being 0
Time Frame
6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Title
Employment status
Description
Employment status will be collected as: Employed full-time, Employed part-time, Not employed due to knee problems, Not employed due to reasons other than knee problems.
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Title
EuroQol-5 Dimension (EQ-5D)
Description
The EQ-5D measures as a descriptive system comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed written informed consent
One symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified MRI or arthroscopy
Between 18 and 55 years of age
Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, and the rehabilitation protocol
Exclusion Criteria:
BMI ≥ 30 kg/m2
Symptomatic contralateral knee
Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more
Prior surgical treatment of the cartilage using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to enrollment)
Patella dysplasia
Chronic inflammatory arthritis or infectious arthritis
History of autoimmune disease or immunodeficiency
History of connective tissue disease
Intra-articular steroid use within the 3 months prior to enrollment
Other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment
The patient is currently being treated with radiation, chemotherapy, immunosuppression or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone
Pregnancy or lack of adequate contraceptives if a female of child-bearing potential
Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study
Active infection of the index knee
Previous diagnosis of osteoporosis as diagnosed by DEXA, bone densitometry or CT scan
Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
History or current substance or alcohol abuse as defined by the DSM-V
Any other medical condition that the investigator determines would interfere with the validity of the study
Known allergy to porcine collagen
Symptom duration greater than 36 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brona Zikova, PhD
Phone
+41 41 492 53 98
Email
Bronislava.Zikova@geistlich.com
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Waite, RN
Phone
352-281-7747
Email
rpwclinicalresearch@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Despoina Natsiou Schmiady, PhD
Organizational Affiliation
Geistlich Pharma AG
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kevin Plancher, MD
Organizational Affiliation
Plancher Orthopedics and Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The MORE Foundation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyse Williams
Phone
623-241-8639
Email
alyse.williams@more-foundation.org
First Name & Middle Initial & Last Name & Degree
Susan Mauro
Email
susan.mauro@more-foundation.org
First Name & Middle Initial & Last Name & Degree
Michael Rose, MD
Facility Name
CORE Orthopaedic Medical Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farouk Awad
Phone
760-943-6700
Ext
162
Email
fawad@coreorthopaedic.com
First Name & Middle Initial & Last Name & Degree
Gregory Loren, MD
Facility Name
Emory University School of Medicine
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lavanya Veda
Phone
404-778-6608
Email
lavanya.vedanarayanan@emory.edu
First Name & Middle Initial & Last Name & Degree
Matthew Pombo, MD
Facility Name
MedStar Orthopaedics Institute
City
Timonium
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Loveland
Phone
404-778-6608
Email
amy.loveland@medstar.net
First Name & Middle Initial & Last Name & Degree
Flossine Brown
Phone
(301)832-5960
Email
flossine.brown@medstar.net
First Name & Middle Initial & Last Name & Degree
James Dreese, MD
Facility Name
Plancher Orthopedics and Sports Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Petterson, MPT, PhD
Phone
203-869-2002
Ext
14
Email
spetterson@ofals.org
First Name & Middle Initial & Last Name & Degree
Kevin Plancher, MD
Facility Name
Fraser Orthopaedic Institute
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 0E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyrsten Payne
First Name & Middle Initial & Last Name & Degree
Parth Lodhia, MD
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Breanne Flood
Phone
(289) 237-7380
Email
bflood@stjosham.on.ca
First Name & Middle Initial & Last Name & Degree
Moin Khan, MD
Facility Name
Martin Luther Krankenhaus
City
Berlin
ZIP/Postal Code
14139
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerstin Hofschulz
Email
Kerstin.Hofschulz@jsd.de
First Name & Middle Initial & Last Name & Degree
Wolf Petersen, Prof
Facility Name
Universitätsklinikum Schleswig Holstein Campus Lübeck
City
Lübeck
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steffen Herzmann
Email
Steffen.Herzmann@uksh.de
First Name & Middle Initial & Last Name & Degree
Andreas Unger, MD
First Name & Middle Initial & Last Name & Degree
Dominik Vogt, MD
Facility Name
Orthopädische Chirurgie München
City
München
ZIP/Postal Code
81369
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Niemeyer, Prof
First Name & Middle Initial & Last Name & Degree
Mirco Harbort, Prof
Facility Name
Sportklinik Ravensburg
City
Ravensburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Kloss
Phone
+49 751 366 17 62-0
Email
h.kloess@sportklinik-ravensburg.de
First Name & Middle Initial & Last Name & Degree
Martin Volz, MD
Facility Name
University Hospital Regensburg
City
Regensburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manju Ganesh-Kumar
Email
manju.ganesh-kumar@ukr.de
First Name & Middle Initial & Last Name & Degree
Peter Angele, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee
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