A clinical study to evaluate the safety and effectiveness of NOVOCART® 3D plus compared to the standard of care (microfracture) in the treatment of cartilage defects of the knee.

• Conditions: Repair of localized, full-thickness cartilage defects of the femoral condyle (medial, lateral or trochlea) of 2-6cm².; MedDRA version: 18.1Level: PTClassification code 10052913Term: Cartilage operationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: LLTClassification code 10007705Term: Cartilage damageSystem Organ Class: 100000004863; MedDRA version: 18.1Level: LLTClassification code 10057104Term: Cartilage repairSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10064112Term: Cartilage graftSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

• Registration Number: EUCTR2011-005798-22-HU
• Lead Sponsor: TETEC – Tissue Engineering Technologies – AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-29
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

Pre-operative inclusion criteria:
At visit 1 patients must meet the following inclusion criteria for enrollment; all criteria must be answered with yes” before the patient is scheduled for arthroscopy:
1. Patient is = 18 and = 65 years old at screening.
2. Patient has a localized articular cartilage defect of the femoral condyle or the trochlea of the knee. 2 localized cartilage defects are accepted if the total defect size is = 6 cm2 and the size of each individual lesion is = 2 cm2, both cartilage defects are located at the femoral condyle and/or the trochlea and both cartilage defects are to be treated with NOVOCART® 3D plus or microfracture.
3. Patient has a defect size = 2 and = 6 cm2. Note: defect size can be estimated by MRI at visit 1 if no data is available from medical history.
4. Patient has an intact articulating joint surface (= Grade 2 International Cartilage Repair Society [ICRS] classification, no kissing lesions”). Note: ICRS classification can be estimated by MRI at visit 1 if no data is available from medical history.
5. Patient has an intact meniscus; a maximum of 50% resection is allowed. Note: status of meniscus can be estimated at visit 1 if no data is available from medical history.
6. Patient has a stable knee joint or sufficiently reconstructed ligaments. If not, ligament repair must be done before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
7. Patient has free range of motion of the affected knee joint or = 10° of Extension and flexion loss.
8. Patient has a defect-grade of III or IV according to the ICRS classification. Note: ICRS classification can be estimated by MRI at visit 1 if not data is available from medical history.
9. Patient has a baseline score of = 60/100 on the 2000 International Knee Documentation Committee (IKDC) subjective knee evaluation.
10. Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow-up visits and assessments and postoperative rehabilitation regimen.
11. Mandatory for France only: Patient benefits of a health insurance regimen.

Intra-operative inclusion criteria:
Patients who are eligible for the study according to the inclusion/exclusion criteria assessed at visit 1 will be scheduled for arthroscopy (visit 2). At visit 2, the following inclusion criteria from visit 1 need to be confirmed; all criteria must be answered with yes” before the patient is randomized into the study:
1. Patient is not pregnant as confirmed by urine pregnancy test before arthroscopy.
2. Patient has a localized articular cartilage defect of the femoral condyle or the trochlea of the knee. 2 localized cartilage defects are accepted if the total defect size is = 6 cm2 and the size of each individual lesion is = 2 cm2, both cartilage defects are located at the femoral condyle and/or the trochlea and both cartilage defects are to be treated with NOVOCART® 3D plus or microfracture.
3. Patient has a defect size = 2 and = 6 cm2 post-debridement.
4. Patient has an intact articulating joint surface (= Grade 2 International Cartilage Repair Society [ICRS] classification;) no kissing lesions”).
5. Patient has an intact meniscus; a maximum of 50% resection is allowed (no indication for concurrent meniscus transplant).
6. Patient has a stable knee joint or sufficiently reconstructed ligaments. If not, ligament repair must be done during or within 6 weeks after cartilage Treat

Exclusion Criteria

Pre-operative exclusion criteria:
At visit 1 none of the following exclusion criteria must apply to any enrolled patient; all criteria must be answered with no” before the patient is scheduled for arthroscopy:
1. Patient is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
2. Patient is unable to undergo magnetic resonance imaging (MRI).
3. Patient has prior surgical treatment of the target knee using mosaicplasty, autologous chondrocyte transplantation and/or microfracture. Note: prior diagnostic arthroscopies with debridement and lavage are acceptable. Ligament repair is accepted, if performed before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
4. Patient has radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade = 2 (see Appendix A).
5. Patient has chronic inflammatory arthritis and/or infectious arthritis.
6. Patient has joint space narrowing > 1/3 in the target knee when compared to the other knee or < 3 mm joint space measured on x-ray.
7. Patient has malalignment (valgus- or varus-deformity) in the target knee. Note: In suspected cases, the mechanical axis must be established radiographically by complete leg imaging in standing position and in a.p. or rather p.a. projection. The Mikulicz line is not allowed to deviate more than 5 mm of the eminentia intercondylaris. If alignment is necessary, surgery has to be performed before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
8. Patient has prior surgical treatment of clinical relevance of the target knee.
9. Patient has an osteochondral defect.
10. Patient has bilateral lower limb pain or low back pain.
11. Patient has a known systemic connective tissue disease.
12. Patient has a current uncontrolled diabetes.
13. Patient has a known history of autoimmune disease.
14. Patient has a known history of immunological suppressive disorder or is taking immunosuppressants.
15. Patient is currently systemically or intra-articularly taking steroids and/or has used steroids within the last 30 days prior to screening visit 1.
16. The patient has a history of HIV/AIDS.
17. The patient has a history of syphilis (Treponema pallidum).
18. The patient has an active hepatitis B or C infection with verified antigens. Note: Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded.
19. The patient has at the site of surgery an active systemic or local microbial infection, eczematization or inflammable skin alterations (including protozoonosis: Babesiosis, Trypanosomiasis (e.g. Chagas-Disease), Leishmaniasis, persistent bacterial infections, like Brucellosis, spotted and typhus fever, other Rickettsiosis, Leprosy, Recurrent Fever, Melioidosis or Tularaemia).
20. Patient has a known history of cancer within the past 5 years.
21. Patient has a known history of osteoporosis; also patients with primary hyperparathyroidism or hyperthyroidism without satisfactory treatment, chronic renal failure or patients with prior pathological fractures independent of the genesis are excluded.
22. Patient has any degenerative muscular or neurological condition that would interfere with evaluation of outcome measures including but not limited to Parkinson’s disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis (MS).
23. Patient has a body ma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified