The objective of this study is to evaluate efficacy and the safety of GelrinC® implant microfracture in the treatment of patients with symptomatic articular cartilage defect(s) of the femoral condyle.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
musculoskeletaal stelsel (gewrichtskraakbeen)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study will have two co-primary endpoints, aiming to demonstrate
significant on either or both:
- Change in KOOS Pain subscale score from baseline to 18 months.
- Change in Overall KOOS score from baseline to 18 months
Secondary outcome
Safety
- will be evaluated by AEs, unanticipated device effects and subsequent
interventions through 24 months post treatment.
Performance of GelrinC will be evaluated based procedural technical success
according to the following criteria
- In situ device placement; device polymerization and device retention
following mobility of the knee (no tearing or
delamination events)
Efficacy of GelrinC for the treatment of the cartilage lesions will be assessed
by:
- Changes measured by KOOS Subscale/s at 6, 12,24, 36, 48 and 60 months post
treatment relative to baseline.
- Change in IKDC (subjective and objective) at 6, 12, 18 and 24 months post
treatment relative to baseline.
Change in IKDC (subjective ) at 36, 48 and 60 months post treatment relative
to baseline.
- Change in SF 36 at 12, 18 and 24 months post treatmentrelative to baseline.
- Change in VAS at 3, 6, 12, 18, and 24 months post treatment relative to
baseline.
- ICRS arthroscopic cartilage repair assessment under the following
circumstances:
o Need for a therapeutic arthroscopy at any timepoint during the
study period
- Change in MRI to assess defect fill, quality and structure of the tissue at
6,12,18 and 24 months post treatment relative to immediate post procedure
assessment (obtained within 3 months of index procedure). . MRI scan will also
be done at 1 and 3 months for the first 5 patients only. This data will be
analyzed and used to determine whether scans at this time points have clinical
value to be implemented in future
studies.
- Rate of re-intervention at 36, 48 and 60 months post treatment .
Background summary
Adult cartilage has a poor intrinsic capacity for repair since it is an
aneural, avascular and hypocellular tissue. Partial thickness injuries of
articular cartilage stimulate limited chondrocyte activity and in the absence
of subchondral bleeding, rarely result in the formation of effective repair
tissue. The newly synthesized cartilaginous matrix is often insufficient to
fill the defect and subsequently fails to restore the surface of the joint and
may deteriorate over the near-term.
Multiple techniques have been described for surgical cartilage repair with each
aiming to improve the cartilage quality at the site of the defect, limit pain,
improve function and prevent degenerative joint disease. Currently, six
techniques are used to treat cartilage lesions : palliative treatments such as
debridement and lavage, intrinsic repair enhancement through marrow
stimulation, whole tissue transplantation, cell-based repair, cell-based
scaffold repairs, scaffolds .
Gelrin C®, is a biodegradable matrix indicated for both chondral and
osteochondral focal defects. The polymer is mainly composed of polyethylene
glycol (PEG) and denatured fibrinogen and is applied to cartilage defects as a
liquid which is transformed to a soft elastomeric solid under UV light. Both
PEG and fibrinogen have a long and successful history in medical implants.
GelrinC® itself is a hydrogel containing more than 90% water and has been shown
to allow 3D ingrowth and migration of cells throughout its structure.
Study objective
The objective of this study is to evaluate efficacy and the safety of GelrinC®
implant microfracture in the treatment of patients with symptomatic articular
cartilage defect(s) of the femoral condyle.
Study design
This is a single arm, open label multi-center study to determine safety and the
performance of the treatment of cartilage lesions located on the femoral
condyle with GelrinC.
Patients meeting inclusion/exclusion criteria at screening will be enrolled
into the study, and will receive treatment implantation into their cartilage
lesions.Treatment will consist of GelrinC implantations at the symptomatic
lesion(s) of femur rated as ICRS III, or IVA with less than 6 mm of bone loss
below the subchondral plate.
The patients will be undergo a rehabilitation program during the follow up
period.
In addition to the safety assessments, performance will be assessed.
Performance evaluations will include improvement in pain, based on an
evaluation utilizing KOOS Pain Subscale; KOOS Subscales, International Knee
Documentation Committee (IKDC) subjective knee evaluation, SF-36, VAS and IKDC
Knee Physical evaluation. The evaluations will be conducted by the patient and
the study investigator respectively.
Magnetic Resonance Imaging (MRI) will be performed to the treated knee joint at
baseline (can be obtained within 3 months before initiation of the study as
defined in the inclusion criteria) and at 6, 12,18 and 24 months post surgery
using ICRS image acquisition protocol and assessment criteria.
MRI scan will also be done at 1 and 3 months at first 5 patients only. This
data will be analyzed and used to determine whether scans at this
time points have clinical value to be implemented in future studies.
The MRI will be assessed by an independent radiologist pre-operatively to
determine the quality and clarity of the MR images to ensure that a
postoperative comparative analysis can be performed. The independent
musculoskeletal radiologist may request that a preoperative MRI will be
performed prior to surgery.
Intervention
Eligible patients will be be treated with GelrinC®.
Second ICRS grade III and IVa cartilage defects to be treated in the target
knee must be treated with the same procedure. Grade I or II cartilage defects
are either left untreated or can be treated with debridement only. Guidance on
the surgical procedures involved in the study is provided in the IFU.
The GelrinC® procedure, involves a standard microfracture procedure as a
pre-requisite procedural step. In addition, being designed to similarly aid in
the repair of articular cartilage defects, while filling the defect site and
providing cell scaffolding properties for cells migrating in the blood and thus
supporting tissue regeneration.
GelrinC® is applied to cartilage defects as a liquid which is transformed to a
soft elastomeric solid under UV light.
Study burden and risks
The burden for the trial participants is that they have to undergo a more
extensive post-operative follow up and rehabilitation program compared to
standard patients treated outside this study.
The risks associated to the treament with GelrinC are standard risks associated
with mini-arthrotomy and are:
• prolonged inflammation of the knee joint
• improper implant placement in the lesion(s) which may result in a second
implantation of GelrinC during the same procedure
• possible tearing or displacement of the GelrinC implant may have an effect on
the quality of the newly formed tissue
• possible allergic reaction to the materials in the implant
The subject treated with the GelrinC implant may benefit,compared to standard
microfcature, from a better reduction of pain, an improved quality of life and
an improved clinical outcome.
Ha'ilan Street 2
Or-Akiva 30600
IL
Ha'ilan Street 2
Or-Akiva 30600
IL
Listed location countries
Age
Inclusion criteria
1. Males or females >= 18 and <= 65 years of age.
2. One or two symptomatic lesions to the femoral condyle; patient must present with pain in the index knee of moderate or severe level (VAS score >=5)
3. If Female: Actively practicing a contraception method, or practicing abstinence, or surgically sterilized, or postmenopausal
4. Understands and voluntarily signs and dates an informed consent document.
5. At least one lesion with Grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion
6. Willingness to follow standardized rehabilitation procedures.
7. Willingness and ability to comply with the requirements of this protocol, including returning for evaluation (clinical and imaging) at periodic intervals post-treatment.
8. Study knee has intact ligaments
9. Ipsilateral knee compartment has intact menisci (or requires partial menistectomy resulting in stable menisci)
10. Contralateral knee is asymptomatic, stable and fully functional.
11. MRI obtained preoperatively within 3 months of Surgery.;Intra-operative arthroscopic confirmation:
1. One or two symptomatic lesions located on the femoral condyle of the femur rated each as ICRS III, or IVA with less than 6 mm of bone loss below the subchondral plate
2. Individual defect size between 1 cm2 - 6 cm2 after arthroscopic debridement.
Exclusion criteria
1. More than two Grade III or IVA symptomatic lesions (more asymptomatic lesions are allowed)
2. Untreatable Posterior symptomatic lesion
3. Lesion greater than 6cm2
4. ICRS Grade larger than grade II on a surface that directly opposes the defect
5. Diffuse Osteoarthritis or avascular necrosis (clinical and/or radiographic diagnosis)
6. History of autoimmune disease or inflammatory arthropathy
7. History of chronic debilitating systemic disease and any other unstable cardiac and pulmonary disorders.
8. History of current or prior malignancy within the last 5 years.
9. Patients treated in the affected knee with microfracture in the last 12 months or had tendon repair, meniscus repair, ligament repair or realignment surgery in the affected knee within the last 6 months.
10. Patient with prior total or subtotal meniscectomy.
11. Body Mass Index (BMI) >32 Kg/m2
12. `Patients with known HIV, Hepatitis A, B, or C infections or other immunedeficient state.
13. Patients requiring immuno-suppressive medications.
14. Clinically significant organic disease
15. Patients received any other investigational products within 6 months prior to study enrollment.
16.
17. Taking specific OA drugs within 2 weeks of the screening
18. Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulant, or taking corticosteroids
19. Uncontrolled diabetes
20. Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee
21. Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
22. Any evidence of the following diseases in the target joint :septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget's disease of bone,ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation
23. Current diagnosis of osteomyelitis
24. Liver enzymes (SGOT, SGPT, Alkaline Phosphatase) of more than two times the upper limit of normal or any other result that is clinically important according to the Investigator
25. CRP > 10 mg/l
26. Clinically significant abnormal finding on screening laboratory parameters.
27. Clinically relevant compartment mal-alignment (> 5 degrees)
28. Patients with a history of bleeding disorders, patients receiving anti-platelet therapy or other anticoagulant medication use within 10 days prior to the beginning of the study, or patients in whom antiplatelet or other anticoagulant medication use is anticipated during the course of the study.
29. Symptomatic lesion to the trochlea
30. Any condition that prevents the patient from undergoing MRI evaluation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00989794 |
| CCMO | NL41672.068.13 |