Evaluate the performance of the Agili-C in the repair of Cartilage and Osteochondral defects.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement in KOOS Pain Subscale
Secondary outcome
• Improvement in KOOS Score and Subscales
• Improvement in IKDC Subjective Knee Score (and VAS as part of it)
• Improvement in Knee Examination Form - 2000
• Improvement in SF 36 Questionnaire
• Improvement in Tegner score
• Improvement in Lysholm Knee Coring Scale
• Improvement in new MOCART Scoring
Background summary
The natural joint consists of two main tissues: articular cartilage and
subchondral bone. Together they form the load-bearing system that allows the
normal large joint range of motion. The cartilage protects the subchondral bone
from high stresses, absorbs shock, distributes load, facilitates stable motion
within the joint and provides the self-lubricating surface. Unlike other
tissues, cartilage is generally considered to have a very limited capacity for
self-repair. Defects and degeneration of the articular cartilage surfaces of
joints cause pain, joint swelling and stiffness; moreover, they can lead to
premature joint degradation (meaning decrease in function and joint motion).
Damage to the cartilage might be a result of a wide variety sources such as
physical injury, trauma, sports, disease and repetitive stresses.
Current treatments for cartilage damage, such as debridement or micro fracture,
often generate scar tissue (Fibrocartilage) and no hyaline cartilage. This
tissue does not have sufficient inferior biomechanical properties to bear
weight.
Agili-C is a natural, single-step implant that allows a full regeneration of
hyaline cartilage, which previously was not possible, and leads to an optimal
recovery of cartilagelesions.
Study objective
Evaluate the performance of the Agili-C in the repair of Cartilage and
Osteochondral defects.
Study design
Prospective, Interventional, Non-Randomized, Open Label, Single Group
Assignment, Multi Center, Multi national study .
Intervention
Each study participant will receive the Agili-C bi-phasic Implant: this trial
is single-arm, meaning that all the patients enrolled in the trial will undergo
the implantation of the device.
The implantation is performed during an arthroscopy or mini-arthrotomy
procedure and requires general anaesthesia, as per surgeon*s discretion. The
surgeon will remove the diseased area of cartilage and bone and insert a
cylindrical Agili C implant to replace this area. This insertion might require
opening the joint through a larger incision (mini-arthrotomy) or through the
same mini-puncture wounds of the arthroscopy itself. This depends on the
location of the damaged area as well as its extent and other factors, and will
be decided by your surgeon during surgery.
In case more than one indication will be treated (e.g. reconstruction of
ligaments), there is a possibility that a larger incision or other associated
procedures will be required during the surgery, depending on findings during
the procedure.
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 possible risks of this study are risks associated in general in
kneesurgeries, risks related to the device and additional risks. (see E9).
The subjects treated with Agilig-C may benefit, compared to standard
microfracture, from a better reduction of pain and an improved clinical
outcome.
Atir Yeda 17
Kfar Saba 4464313
IL
Atir Yeda 17
Kfar Saba 4464313
IL
Listed location countries
Age
Inclusion criteria
1. 18 to 55 years
2. Symptomatic, Painful, single, focal, full or near full-thickness (ICRS cartilage defect description grades 3 and 4) chondral or osteochondral (grade 1,2,3,4A) isolated lesion of the femoral condyle, trochlea or the tibial plateau (limited to 4 millimeters in depth).
3. KOOS pain score is < 60 at baseline evaluation
4. Defect area is less than 3.5 cm². The defect is completely surrounded on all sides by healthy cartilage.
5. Primary or secondary articular cartilage repair.
6. Knee is stable or can be stabilized as a concomitant procedure.
7. Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.
8. Informed consent signing.
9. Any misalignments must be fully corrected at the end of the operative procedure.
Exclusion criteria
1. Uncorrected axial misalignments >5° that cannot be corrected.
2. Patellar cartilage defects or pathology.
3. Meniscal resection of more than 50%, either in a previous procedure or concomitant with articular cartilage repair.
4. Any tumor of the ipsilateral knee, any concurrent malignant tumor or any metastatic tumor in the past or in the present.
5. Present or past acute or chronic infection of the treated knee.
6. Inflammatory arthropathy or crystal-deposition arthropathy.
7. Systemic cartilage and/or bone disorder; This implant's integration is dependent on surrounding live bleeding bone; therefore it must not be implanted within sequestrated or necrotic bone
8. Bony defect depth over 4 millimeters.
9. Body mass index >35.
10. Asymptomatic articular cartilage defects.
11. Bipolar articular cartilage defects.
12. Osteoarthritis of the operated knee.
13. Oral medications such as systemic corticosteroid therapy taken less than one year prior to the surgery or chemotherapy.
14. Previous arthroscopic marrow stimulation or cell therapy within the last 6 months
15. Any previous cartilage treatment within the last 6 months
16. Patients who are sensitive to materials containing calcium carbonate or hyaluronate.
17. Pregnant women, Women of Childbearing Potential [WOCBP-defined as any female who has experienced menarche and does not meet the criteria for *Women Not of Childbearing Potential* which are: women who are postmenopausal,permanently sterilised (e.g. tubal ligation, hysterectomy, bilateral salpingectomy)], women who are not using a highly effective contraception method (as defined by ICH M3) during the entire duration of the clinical trial or breastfeeding women.
18. Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, severe vascular or neurological disease or acute injury that might compromise the Subject's welfare.
19. Substance abuse or alcohol abuse.
20. Participation in other clinical trials in parallel to this study.
21. Type I diabetes.
22. Unable to undergo MRI or X-ray.
23. Any reasons making the Subject a poor candidate in the opinion of the investigator.
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 |
|---|---|
| CCMO | NL49634.018.14 |