Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects (HIP-ACTION)

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)

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

Study Overview

• Status: Completed
• Conditions: Cartilage Disease

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • University Hospital Carl Gustav of TU Dresden
  • Essen, Germany, 45147
    • Essen University Hospital
  • Straubing, Germany, 94315
    • sporthopaedicum Straubing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

specialist clinical centre

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cartilage defects in the hip joint; NOVOCART® Inject Autologous Chondrocyte Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.	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.	Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tetec AG
• Collaborators: Aesculap AG
• Investigators: Principal Investigator: Klaus-Peter Guenther, Prof. MD, Universitätsklinikum Carls Gustav Carus der TU Dresden

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 18, 2018

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: June 27, 2014
• First Posted (Estimate): July 1, 2014

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: hip; cartilage defect; impingement
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: AAG-O-H-1304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO