Smith & Nephew's European Trufit Study
Primary Purpose
Defect of Articular Cartilage
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Trufit CB (Cartilage Bone) Implant
Microfracture if the knee
Sponsored by
About this trial
This is an interventional treatment trial for Defect of Articular Cartilage
Eligibility Criteria
Inclusion Criteria:
- Capable of providing informed consent;
- Eighteen (18) years or older and skeletally mature on the date of study enrollment;
- Willing and able to attend all follow up visits and complete all study related procedures and evaluations including, but not limited to adhering to the rehabilitation protocol;
- Single, isolated cartilage defect (ICRS Grade III - IV) in the knee (medial or lateral femoral condyle or trochlea) that is ≥ 1cm2 (10 mm) and ≤ 2cm2 (20 mm) in area and requiring a maximum of 2 implants (if randomized to TRUFIT CB); Note: Lesion size should be assessed as the product of the longest diameter and its perpendicular applied at the widest portion of the lesion.
- Candidate for cartilage repair surgery as a result of a single, isolated symptomatic cartilage lesion;
- Presents with stable health at the time of study enrollment;
- BMI of ≤ 32.
Exclusion Criteria:
- Female of child-bearing potential who is pregnant or plans to become pregnant over the course of the study;
- History of alcohol or drug abuse;
- Presents with patellofemoral instability or other anatomical malalignment in the study knee;
- Any diagnosis that would preclude the patient from successfully completing the study rehabilitation protocols;
- Unable or unwilling to follow post operative procedures (e.g. rehabilitation protocol);
- Received one or more intra-articular steroid injections in the study knee within the previous 3 months;
- Presents with ipsilateral hip disease, as determined by pain or restricted range of motion upon physical examination;
- Treated with either an investigational device or drug within one (1) month of study enrollment, or plans to be treated with an investigational device or drug in the next 24 months;
- Diagnosed rheumatoid arthritis, ankylosing spondylitis (Bechterew syndrome), or calcium pyrophosphate dihydrate disease(chondrocalcinosis);
- History of severe vascular or neurological disease, uncontrolled diabetes, or is immunosuppressed (e.g. HIV positive);
- Musculoskeletal disease, including degenerative bone diseases such as osteochondritis dissecans and osteonecrosis;
- Pathologic conditions of the bone (e.g. osteoporosis, cystic changes, hyperparathyroidism, Paget's Disease, hypercalcemia, prolonged use of steroids);
- Active infection, or evidence thereof, at the lesion site;
- Requires the use of any medication(s) or treatment(s) known to have an effect on bone metabolism (e.g. bisphosphonates, chemotherapeutic or immunosuppressive agents);
- Requires concomitant osteotomy, partial lateral meniscectomy or complete meniscectomy; Note: Concomitant ACL reconstruction or revision, as well as meniscal repair and partial medial meniscectomies are permitted under the study protocol.
- Has undergone an ACL reconstruction, osteotomy, chondral resurfacing procedure or partial meniscectomy (≤ central third of the meniscus) in the last year and has not completed at least 6 months of rehabilitation since such surgery; Note: Patients who have undergone these procedures within the last year and have completed at least 6 months of rehabilitation are eligible to participate in the study.
- Any active, implanted medical device (e.g. cochlear implant) or metallic implant (other then dental work) that may interfere with Magnetic Resonance Imaging (MRI);
- Any condition (e.g. claustrophobia) that may interfere with the patient's ability to undergo MRI;
- Diagnosis requiring placement of an active implant (e.g. cardiac pacemaker, vagus nerve stimulator, etc.) within the next 24 months.
Sites / Locations
- Karl Brabants, MD
- Prof. Dr. K.F. Almqvist
- Toon Claes, MD
- Johan Vanlauwe
- Aalborg Private Hospital A/S
- Johannes Holz, MD
- Kevin J. Mulhall
- Sander Koeter, MD
- Kees van Egmond, MD
- Lars Engebretsen, MD
- Magnus Forssblad, MD
- Angus Robertson, MD
- Tim Spalding, MD
- David Chesney
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
TRUFIT CB with accelerated rehab.
TRUFIT CB with standard rehab.
• Microfracture with rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
Percent change in the Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline
Secondary Outcome Measures
Percent improvement from baseline in the KOOS Knee Survey Score at all time-points
Positive change in activity level from baseline to each visit, as measured by the Tegner Activity Scale at all time-points.
Difference in Pain Scores on the Visual Analog Scale from baseline at all post operative time-points.
Magnetic resonance evaluation of cartilage and underlying bone using the MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) scale
Proportion of subjects (compared to baseline) with cartilage classifications within the four groups defined by the International Cartilage Repair Society (ICRS) scoring system
Evaluation of cartilage at 24 months post-procedure will only occur for subjects who consent to a second-look biopsy.
Histological evaluation of cartilage
Histological characterization of cartilage will only occur for those subjects consenting to both the second look arthroscopy and biopsy at 24-months post-procedure.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01246635
Brief Title
Smith & Nephew's European Trufit Study
Official Title
A Prospective, Multi-Center, Randomized, Single-Blind, Controlled Study Comparing the Trufit CB (Cartilage Bone) Implant to Microfracture for the Treatment of Patients With Single, Isolated Defects of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early due to slow and insufficient total enrollment.
Study Start Date
April 15, 2008 (Actual)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this clinical study is to demonstrate the effectiveness and safety of the Trufit CB (Cartilage Bone) implant for the treatment of single, isolated cartilage defects of the knee compared to Microfracture.
Detailed Description
Up to 315 subjects, ages 18 years and older with a single, isolated cartilage defect of the knee will be randomized in a 1:1:1 ratio to 1 of 3 treatment groups:
Trufit CB Implant with rehabilitation protocol;
Trufit CB Implant with rehabilitation protocol;
Microfracture with rehabilitation protocol
Rehabilitation program may be standard (6 weeks touch weight to full weight bearing) or accelerated (2 weeks touch weight to full weight bearing).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Defect of Articular Cartilage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRUFIT CB with accelerated rehab.
Arm Type
Experimental
Arm Title
TRUFIT CB with standard rehab.
Arm Type
Experimental
Arm Title
• Microfracture with rehabilitation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Trufit CB (Cartilage Bone) Implant
Intervention Description
Implantation of 5,7, 9, or 11 mm Trufit CB Implants for small cartilage lesions. A maximum of two Trufit CB plugs may be implanted.
Intervention Type
Procedure
Intervention Name(s)
Microfracture if the knee
Intervention Description
Creation of small holes through subchondral bone with the goal of stimulating cartilage growth
Primary Outcome Measure Information:
Title
Percent change in the Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline
Time Frame
6 months post-procedure
Secondary Outcome Measure Information:
Title
Percent improvement from baseline in the KOOS Knee Survey Score at all time-points
Time Frame
2 weeks, 6, weeks, 3 months, (6 months - primary measure), 12 months and 24 months post-procedure
Title
Positive change in activity level from baseline to each visit, as measured by the Tegner Activity Scale at all time-points.
Time Frame
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure
Title
Difference in Pain Scores on the Visual Analog Scale from baseline at all post operative time-points.
Time Frame
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure
Title
Magnetic resonance evaluation of cartilage and underlying bone using the MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) scale
Time Frame
12 and 24 months post-procedure
Title
Proportion of subjects (compared to baseline) with cartilage classifications within the four groups defined by the International Cartilage Repair Society (ICRS) scoring system
Description
Evaluation of cartilage at 24 months post-procedure will only occur for subjects who consent to a second-look biopsy.
Time Frame
24 months post-procedure
Title
Histological evaluation of cartilage
Description
Histological characterization of cartilage will only occur for those subjects consenting to both the second look arthroscopy and biopsy at 24-months post-procedure.
Time Frame
24 months post-procedure
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Capable of providing informed consent;
Eighteen (18) years or older and skeletally mature on the date of study enrollment;
Willing and able to attend all follow up visits and complete all study related procedures and evaluations including, but not limited to adhering to the rehabilitation protocol;
Single, isolated cartilage defect (ICRS Grade III - IV) in the knee (medial or lateral femoral condyle or trochlea) that is ≥ 1cm2 (10 mm) and ≤ 2cm2 (20 mm) in area and requiring a maximum of 2 implants (if randomized to TRUFIT CB); Note: Lesion size should be assessed as the product of the longest diameter and its perpendicular applied at the widest portion of the lesion.
Candidate for cartilage repair surgery as a result of a single, isolated symptomatic cartilage lesion;
Presents with stable health at the time of study enrollment;
BMI of ≤ 32.
Exclusion Criteria:
Female of child-bearing potential who is pregnant or plans to become pregnant over the course of the study;
History of alcohol or drug abuse;
Presents with patellofemoral instability or other anatomical malalignment in the study knee;
Any diagnosis that would preclude the patient from successfully completing the study rehabilitation protocols;
Unable or unwilling to follow post operative procedures (e.g. rehabilitation protocol);
Received one or more intra-articular steroid injections in the study knee within the previous 3 months;
Presents with ipsilateral hip disease, as determined by pain or restricted range of motion upon physical examination;
Treated with either an investigational device or drug within one (1) month of study enrollment, or plans to be treated with an investigational device or drug in the next 24 months;
Diagnosed rheumatoid arthritis, ankylosing spondylitis (Bechterew syndrome), or calcium pyrophosphate dihydrate disease(chondrocalcinosis);
History of severe vascular or neurological disease, uncontrolled diabetes, or is immunosuppressed (e.g. HIV positive);
Musculoskeletal disease, including degenerative bone diseases such as osteochondritis dissecans and osteonecrosis;
Pathologic conditions of the bone (e.g. osteoporosis, cystic changes, hyperparathyroidism, Paget's Disease, hypercalcemia, prolonged use of steroids);
Active infection, or evidence thereof, at the lesion site;
Requires the use of any medication(s) or treatment(s) known to have an effect on bone metabolism (e.g. bisphosphonates, chemotherapeutic or immunosuppressive agents);
Requires concomitant osteotomy, partial lateral meniscectomy or complete meniscectomy; Note: Concomitant ACL reconstruction or revision, as well as meniscal repair and partial medial meniscectomies are permitted under the study protocol.
Has undergone an ACL reconstruction, osteotomy, chondral resurfacing procedure or partial meniscectomy (≤ central third of the meniscus) in the last year and has not completed at least 6 months of rehabilitation since such surgery; Note: Patients who have undergone these procedures within the last year and have completed at least 6 months of rehabilitation are eligible to participate in the study.
Any active, implanted medical device (e.g. cochlear implant) or metallic implant (other then dental work) that may interfere with Magnetic Resonance Imaging (MRI);
Any condition (e.g. claustrophobia) that may interfere with the patient's ability to undergo MRI;
Diagnosis requiring placement of an active implant (e.g. cardiac pacemaker, vagus nerve stimulator, etc.) within the next 24 months.
Facility Information:
Facility Name
Karl Brabants, MD
City
Antwerp
Country
Belgium
Facility Name
Prof. Dr. K.F. Almqvist
City
Ghent
Country
Belgium
Facility Name
Toon Claes, MD
City
Herentals
Country
Belgium
Facility Name
Johan Vanlauwe
City
Leuven
Country
Belgium
Facility Name
Aalborg Private Hospital A/S
City
Aalborg
Country
Denmark
Facility Name
Johannes Holz, MD
City
Hamburg
Country
Germany
Facility Name
Kevin J. Mulhall
City
Dublin
Country
Ireland
Facility Name
Sander Koeter, MD
City
Nijmegen
Country
Netherlands
Facility Name
Kees van Egmond, MD
City
Zwolle
Country
Netherlands
Facility Name
Lars Engebretsen, MD
City
Oslo
Country
Norway
Facility Name
Magnus Forssblad, MD
City
Stockholm
Country
Sweden
Facility Name
Angus Robertson, MD
City
Cardiff
Country
United Kingdom
Facility Name
Tim Spalding, MD
City
Coventry
Country
United Kingdom
Facility Name
David Chesney
City
Fife Keith
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Smith & Nephew's European Trufit Study
We'll reach out to this number within 24 hrs