Clinical trial NCT02179346: Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects
Official title: Observational Study on the Feasibility, Safety and Efficacy in the Biological Reconstruction of the Hip Joint With Full Thickness Cartilage Defects With an in Situ Polymerizable and Chondrocyte Populated Biomaterial (NOVOCART® Inject)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cartilage Disease
Keywords: cartilage defect
hip
impingement
Lead sponsor: Tetec AG
Sponsor class: INDUSTRY
Collaborators: name: Aesculap AG
First posted: 2014-07-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: specialist clinical centre

Brief summary: Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full thickness cartilage defects in the hip.

Detailed description: Prospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with impingement syndrom in the hip.

Safety: 24-month post treatment follow up period by measuring the number of adverse drug reactions/serious adverse drug reactions.

Efficacy: 24-month post treatment follow up period using iHOT 33 and EuroQuol-5D-5L.

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.
timeFrame: 12 months
measure: Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.
timeFrame: 24 months
Secondary outcomes:
measure: iHOT 33 (international HIP Outcome Tool) as a measurement of function and Quality of life
timeFrame: 12 and 24 months
measure: EQ-5D-5L (5-level EQ-5D ) as a measurement of function and Quality of life
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav of TU Dresden
city: Essen
country: Germany
facility: Essen University Hospital
city: Straubing
country: Germany
facility: sporthopaedicum Straubing
Study officials:
affiliation: Universitätsklinikum Carls Gustav Carus der TU Dresden
name: Klaus-Peter Guenther, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: