Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02179346

Acronym

HIP-ACTION

Enrollment

Registered

2014-07-01

Start date

2014-12-31

Completion date

2018-06-18

Last updated

2019-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage Disease

Keywords

cartilage defect, hip, impingement

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.	12 months	Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.

Secondary

Measure	Time frame	Description
iHOT 33 (international HIP Outcome Tool) as a measurement of function and Quality of life	12 and 24 months	Outcome of iHOT 33 as a measurement of function and Quality of life
EQ-5D-5L (5-level EQ-5D ) as a measurement of function and Quality of life	12 and 24 months	Outcome of EQ-5D-5L as a measurement of function and Quality of life

Countries

Germany

Outcome results