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Completed

NCT Number: NCT02179346

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Carl Gustav of TU Dresden, Dresden, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.

    Time frame: 12 months

    Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.

  2. Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.

    Time frame: 24 months

    Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.

Secondary outcomes

  1. iHOT 33 (international HIP Outcome Tool) as a measurement of function and Quality of life

    Time frame: 12 and 24 months

    Outcome of iHOT 33 as a measurement of function and Quality of life

  2. EQ-5D-5L (5-level EQ-5D ) as a measurement of function and Quality of life

    Time frame: 12 and 24 months

    Outcome of EQ-5D-5L as a measurement of function and Quality of life

Sponsors and collaborators

Lead sponsor

Tetec AG

Industry

Collaborators

  • Aesculap AG

Registry information

Official study 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)

Acronym: HIP-ACTION

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 1, 2014
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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