Smith & Nephew's European Trufit Study

NCT01246635 | Terminated DMC

• 1 other identifier: CSA-2005-02
• Study Type: interventional
• Target: 153
• Locations: 8 countries
• Sites: 14

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.

Conditions

Defect of Articular Cartilage

Outcome Measures

Primary Outcomes (1)

• Percent change in the Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline

  6 months post-procedure

Secondary Outcomes (7)

• Percent improvement from baseline in the KOOS Knee Survey Score at all time-points

  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.

  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.

  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

  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

  24 months post-procedure

Study Arms (3)

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

Interventions

Trufit CB (Cartilage Bone) Implant DEVICE

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.

TRUFIT CB with accelerated rehab.; TRUFIT CB with standard rehab.

Microfracture if the knee PROCEDURE

Creation of small holes through subchondral bone with the goal of stimulating cartilage growth

• Microfracture with rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (14)

Karl Brabants, MD

Antwerp, Belgium

Location

Prof. Dr. K.F. Almqvist

Ghent, Belgium

Location

Toon Claes, MD

Herentals, Belgium

Location

Johan Vanlauwe

Leuven, Belgium

Location

Aalborg Private Hospital A/S

Aalborg, Denmark

Location

Johannes Holz, MD

Hamburg, Germany

Location

Kevin J. Mulhall

Dublin, Ireland

Location

Sander Koeter, MD

Nijmegen, Netherlands

Location

Kees van Egmond, MD

Zwolle, Netherlands

Location

Lars Engebretsen, MD

Oslo, Norway

Location

Magnus Forssblad, MD

Stockholm, Sweden

Location

Angus Robertson, MD

Cardiff, United Kingdom

Location

Tim Spalding, MD

Coventry, United Kingdom

Location

David Chesney

Fife Keith, United Kingdom

Location

MeSH Terms

Interventions

Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2010
• First Posted: November 23, 2010
• Study Start: April 15, 2008
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2014
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

NO (1); SE (1); GB (3); NL (2); DK (1); DE (1); IE (1); BE (4)