Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickn⦠(NCT02179346) | Clinical Trial Compass
CompletedNot Applicable
Observational Study With NOVOCARTĀ® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects
Germany21 participantsStarted 2014-12
Plain-language summary
Non-interventional study to evaluate safety and efficacy of NOVOCARTĀ® Inject in patients with full thickness cartilage defects in the hip.
Who can participate
Age range18 Years ā 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients between 18 and 60 years
* Insulated full thickness cartilage damage of the hip joint after ICRS grade 3
* Received subchondral bone lamella
* received or reconstructed labrum in labrum cartilage defects
* defect size ℠1.5 and ⤠10 cm2
* Intact surrounding cartilage structure around the defect, and the corresponding articular surface
* existence of the written informed consent of the patients after Enlightenment
Exclusion Criteria:
* More than 2 defects or 2 corresponding defects
* defects in both lower extremities simultaneously
* Radiographic signs of osteoarthritis of Kellgren \& Lawrence \> 1
* Profound bony lesion \> 0.5 cm in the defect area
* Presence of rheumatoid, infectious or para-infectious arthritis, as well as state after these diseases
* Skin injury to the limb to be operated on
* cartilage defect of the corresponding articular surface
* Existing medications, drugs or alcohol
* Acute infectious diseases, chronic cardiovascular disease, endocrine or metabolic disorders, autoimmune or neoplastic diseases
* impairment of the upper extremity, which prevents discharge by Crutches
* Known bleeding disorder, such as Hemophilia A / B or thrombophilia
* pregnancy and lactation, which represent the time of treatment is a contraindication
* Known allergy to the ingredients
* inmates in prisons
What they're measuring
1
Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.
Timeframe: 12 months
2
Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.