focal femoral cartilage defects in the knee joint MedDRA version: 16.1 Level: LLT Classification code 10007705 Term: Cartilage damage System Organ Class: 100000004863 MedDRA version: 16.1 Level: LLT Classification code 10057104 Term: Cartilage repair System Organ Class: 100000004865
Conditions
Interventions
Trade Name: BioSeed®-C
Product Name: BioSeed®-C
Pharmaceutical Form: Living tissue equivalent
Sponsors
BioTissue Technologies GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Local femoral defect at the knee joint (Outerbridge class III or IV) • Defects at the lateral and medial chondyle • Cartilage defect size: (after defect cleaning) • Patients male and female between 18 and 50 years of age at the time of surgery • Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical evaluations/visits • Patients who have signed the Ethics Committee-approved Informed Consent Form prior to surgery • Indications for microfracture or ACT respectively • focal and contained lesions • full-thickness loss of articular cartilage in weight-bearing areas • unstable cartilage covering the underlying intact subchondral bone • degenerative changes in a knee that is normally aligned Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known allergic reactions or hypersensitivity to bovine proteins, PGA, fibrinogen, thrombin, heparin or hyaluronan • Defect of the femoropatellar joint • Varus and valgus (more than 5°) (30 cm one leg standing apical X-ray) • General osteoarthritis (two or more compartments) • Rheumatoid arthritis or Bechterew’s disease • Joint stiffness (flexion less than 90°) • Obesity > 32 BMI • Laxity • Meniscus lesions with more than 1/3 partial resection • History with previous cartilage surgery (osteochondral transplantation (OCT), autologous chondrocyte transplantation (ACT)) • History with previous microfracture in the symptomatic defect less than 6 months • History with previous knee surgery (anterior crucial ligament, meniscus refixation, osteotomy) less than 6 months • Osteochondral defects • Planned pregnancy, pregnancy and breastfeeding • Autoimmune-diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to show that arthroscopic itransplantation of BioSeed®-C leads to an improved outcome after 12 months compared to the advanced microfracture treatment with implantation of chondrotissue® as assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS).;Secondary Objective: The secondary objective is to show that arthroscopic implantation of BioSeed®-C in large defects (4-6cm2) leads to a similar or better outcome after 12 months compared to arthroscopic advanced microfracture treatment with chondrotissue® as assessed by KOOS. Additionally, the secondary objective is to show that arthroscopic advanced microfracture treatment with chondrotissue® in small defects (1-4cm2) leads to a similar or better outcome after 12 months compared to arthroscopic implantation of BioSeed®-C as assessed by KOOS. Furthermore, tissue regeneration and defect filling will be analysed by MRI pre-operatively and 6, 12, and 24 months after implantation, clinical outcome and pain situation will be further determined by (ICRS, VAS pain, Tegner Score, SF-36, Lysholm) after 0, 6, 12 and 24 months. Product safety will be assessed by patient evaluation questionnaire after 12 and 24 months. ;Primary end point(s): The active pharmaceutical ingredient (autologous chondrocytes) will persist in the defect after BioSeed®-C transplantation.;Timepoint(s) of evaluation of this end point: not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Germany
Contacts
Public ContactClinical Study Managment
BioTissue Technologies GmbH
Outcome results
None listed