Defect of Articular CartilageNCT01246635
Smith & Nephew's European Trufit Study
A study testing Trufit CB (Cartilage Bone) Implant and Microfracture if the knee in people with Defect of Articular Cartilage, run by Smith & Nephew, Inc. at 14 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Defect of Articular Cartilage
- What is being tested?
- Trufit CB (Cartilage Bone) Implant and Microfracture if the knee
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 14 sitesin 8 countries
- Study dates
- 15 Apr 2008to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
14 sites in 8 countries.
14 sites in 8 countries
Belgium4 sites
Karl Brabants, MD
Antwerp
Prof. Dr. K.F. Almqvist
Ghent
Toon Claes, MD
Herentals
Johan Vanlauwe
Leuven
United Kingdom3 sites
Angus Robertson, MD
Cardiff
Tim Spalding, MD
Coventry
David Chesney
Fife Keith
About this 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
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.
Read the 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).
- Conditions
- Defect of Articular Cartilage
- Being tested
- Trufit CB (Cartilage Bone) Implant, Microfracture if the knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trufit CB (Cartilage Bone) ImplantDevice
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.
Microfracture if the kneeProcedure or surgery
Creation of small holes through subchondral bone with the goal of stimulating cartilage growth
| Study group | Role | What they receive |
|---|---|---|
| TRUFIT CB with accelerated rehab. | Experimental | Not described Receives: Device: Trufit CB (Cartilage Bone) Implant |
| TRUFIT CB with standard rehab. | Experimental | Not described Receives: Device: Trufit CB (Cartilage Bone) Implant |
| • Microfracture with rehabilitation | Active comparator | Not described Receives: Procedure: Microfracture if the knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in the Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline
Measured: 6 months post-procedure
Secondary outcomes (7)
Percent improvement from baseline in the KOOS Knee Survey Score at all time-points
Measured: 2 weeks, 6, weeks, 3 months, (6 months - primary measure), 12 months and 24 months post-procedure
Positive change in activity level from baseline to each visit, as measured by the Tegner Activity Scale at all time-points.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure
Difference in Pain Scores on the Visual Analog Scale from baseline at all post operative time-points.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure
Magnetic resonance evaluation of cartilage and underlying bone using the MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) scale
Measured: 12 and 24 months post-procedure
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.
Measured: 24 months post-procedure
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.
Measured: 24 months post-procedure
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study start15 Apr 2008
- Primary completionNov 2011
- Study completionDec 2014
Why it stopped: The study was terminated early due to slow and insufficient total enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defect of Articular CartilageStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246635
- Sponsor's protocol ID
- CSA-2005-02
- Status last verified
- Mar 2021
- First submitted
- 14 Nov 2010
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01246635
- Acronym / sponsor ID
- CSA-2005-02
- Conditions
- Defect of Articular Cartilage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to slow and insufficient total enrollment.
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2008 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRUFIT CB with accelerated rehab. | Experimental | Device: Trufit CB (Cartilage Bone) Implant |
| TRUFIT CB with standard rehab. | Experimental | Device: Trufit CB (Cartilage Bone) Implant |
| • Microfracture with rehabilitation | Active comparator | Procedure: Microfracture if the knee |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (19 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trufit CB (Cartilage Bone) ImplantImplantation of 5,7, 9, or 11 mm Trufit CB Implants for small cartilage lesions. A maximum of two Trufit CB plugs may be implanted. | Device | TRUFIT CB with accelerated rehab., TRUFIT CB with standard rehab. |
| Microfracture if the kneeCreation of small holes through subchondral bone with the goal of stimulating cartilage growth | Procedure or surgery | • Microfracture with rehabilitation |
Primary outcome
Percent change in the Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline
Time frame: 6 months post-procedure
7 secondary outcomes
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
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
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
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
Proportion of subjects (compared to baseline) with cartilage classifications within the four groups defined by the International Cartilage Repair Society (ICRS) scoring system
Time frame: 24 months post-procedure
Histological evaluation of cartilage
Time frame: 24 months post-procedure
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
Results and safety
The study was stopped early (reason given: The study was terminated early due to slow and insufficient total enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
Related trials for Defect of Articular Cartilage
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
RecruitingPhase 3
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Chondral Defect, Osteochondritis Dissecans (OCD)
Not yet recruiting
Biologic Augmentation of Osteochondral Allograft Transplantation in the Knee
Osteochondral Defect, Articular Cartilage Defect
RecruitingPhase 1
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Hip Arthroscopy, Articular Cartilage Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trufit CB (Cartilage Bone) Implant and Microfracture if the knee in people with Defect of Articular Cartilage, run by Smith & Nephew, Inc. at 14 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Belgium, United Kingdom, Netherlands, Denmark, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to slow and insufficient total enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in the Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.