A comparative observational clinical study on efficacy ofBioSeed®-C and chondrotissue® treatment of cartilage defects in the knee joint.

Phase 1

• Conditions: focal femoral cartilage defects in the knee joint; MedDRA version: 16.1Level: LLTClassification code 10007705Term: Cartilage damageSystem Organ Class: 100000004863; MedDRA version: 16.1Level: LLTClassification code 10057104Term: Cartilage repairSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-003594-28-DE
• Lead Sponsor: BioTissue Technologies GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-14
• Last Update Posted: 16 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

•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

Study & Design

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