A Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D plus Compared to Microfracture in the Treatment of Articular Cartilage Defects of the Knee - NOVOCART® 3D plus (N3D) Study

TETEC AG0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月23日

试验速览

阶段: 3 期
状态: 撤回
发起方: TETEC AG
入组人数: 30

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•*Patient is * 18 and * 65 year old at time of screening
•*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 post-debridement, 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..
•* Patient has a defect size * 2 and * 6 cm2post-debridement.
•* Patient has an intact (< Grade 2 ICRS classification) articulating joint surface (no *kissing lesions*).
•* Patient has an intact meniscus (maximum 1/2-resection).
•*Patient has a stable knee joint or sufficiently reconstructed ligaments. If not, ligament repair has to be done within 6 weeks to the planned cartilage treatment (ACT/microfracture).
•*Patient has free range of motion of the affected knee joint or *10 degrees of extension and flexion loss.
•*Patient has a defect of grade III or IV according to the ICRS classification.
•*Patient has a maximum baseline score of 60/100 on the 2000 IKDC subjective knee evaluation.
•*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.

排除标准

•Only selected (preoperative) exclusion criteria have been listed below. For the complete list see protocol.
•Preoperative exclusion criteria:
•* Patient is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
•* Patient is unable to undergo magnetic resonance imaging (MRI).
•* Patient has prior surgical treatment of the target knee using mosaicplasty and/or microfracture (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable). Anterior cruciate ligament repair are accepted, if the target knee is stable or a primary ACL reconstruction is performed within 6 weeks to the planned cartilage treatment (ACT/microfracture).
•* Patient has radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade > 2.
•* Patient has chronic inflammatory arthritis, and/or infectious arthritis.
•* 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.
•* Patient has an instable knee joint or unsufficiently reconstructed ligaments. If ligament repair is necessary, the repair has to be performed within 6 weeks to the planned cartilage treatment (ACT/microfracture).
•* Patient has malalignment (no valgus- or varus-deformity) in the target knee. In suspected cases, the mechanical axis must be established radiographically through complete leg imaging during standing 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 within 6 weeks to the planned cartilage treatment (ACT/microfracture).
•* Patient has prior surgical treatment of clinical relevance of the target knee.
•* Patient has an osteochondral defect.
•* Patient has bilateral lower limb pain or low back pain.
•* Patient has a known systemic connective tissue disease.
•* Patient has a known history of diabetes.
•* Patient has a known autoimmune disease.
•* Patient has a known immunological suppressive disorder or is taking immunosuppressants.
•Patient is currently systemically or intra-articularly taking steroids and/or has used steroids within the last 30 days prior to the planned arthroscopy (tissue harvest/microfracture).
•* The patient has a known history of HIV/AIDS.
•* The patient has a known history of Treponema pallidum (syphilis).
•* The patient has an active hepatitis B or C infection with verified antigens. Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded.
•* 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).
•* Patient has a known history of cancer.
•* Patient has a known allergy against any of the ingredients of the IMP (NOVOCART® 3D plus).e.g. bovine proteins
•* Patient is taking indomethacin or other NSAIDs as acute anti-pain and/or antiinflammatory
•medication.
•* Patient has a known history of osteoporosis;
•also patients with primary hype

研究者

发起方

TETEC AG

相似试验

进行中（未招募）

1 期

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.

EUCTR2011-005798-22-DETETEC – Tissue Engineering Technologies – AG261

进行中（未招募）

1 期

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.

EUCTR2011-005798-22-LVTETEC – Tissue Engineering Technologies – AG261

进行中（未招募）

1 期

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.Repair of localized, full-thickness cartilage defects of the femoral condyle (medial, lateral or trochlea) of 2-6cm².MedDRA version: 20.0Level: PTClassification code 10052913Term: Cartilage operationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10007705Term: Cartilage damageSystem Organ Class: 100000004863MedDRA version: 20.0Level: LLTClassification code 10057104Term: Cartilage repairSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10064112Term: Cartilage graftSystem Organ Class: 10042613 - Surgical and medical procedures

EUCTR2011-005798-22-PLTETEC – Tissue Engineering Technologies – AG261

进行中（未招募）

1 期

EUCTR2011-005798-22-LTTETEC – Tissue Engineering Technologies – AG261

进行中（未招募）

1 期

EUCTR2011-005798-22-CZTETEC – Tissue Engineering Technologies – AG261