Cartilage DiseaseHIP-ACTIONNCT02179346
Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects
An observational study of Cartilage Disease, run by Tetec AG at 3 sites in Germany.
Trial summary
Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full thickness cartilage defects in the hip. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cartilage Disease
- How many people
- 21 participants
- Where
- 3 sitesGermany
- Study dates
- Dec 2014to 18 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: specialist clinical centre
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Hospital Carl Gustav of TU Dresden
Dresden, 01307
Essen University Hospital
Essen, 45147
sporthopaedicum Straubing
Straubing, 94315
About this study
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)
Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full thickness cartilage defects in the hip.
Read the 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.
- Conditions
- Cartilage Disease
- Keywords
- cartilage defect, hip, impingement
- Medical subject headings
- Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cartilage defects in the hip joint | NOVOCART® Inject Autologous Chondrocyte Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months
Secondary outcomes (2)
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
Measured: 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
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2018
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aesculap AG
- Responsible party
- Sponsor
- Investigators
- Klaus-Peter Guenther, Prof. MD, Principal investigator, Universitätsklinikum Carls Gustav Carus der TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179346
- Sponsor's protocol ID
- AAG-O-H-1304
- Acronym
- HIP-ACTION
- Status last verified
- Dec 2019
- First submitted
- 27 Jun 2014
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02179346
- Acronym / sponsor ID
- HIP-ACTION / AAG-O-H-1304
- Conditions
- Cartilage Disease
- Keywords
- cartilage defect, hip, impingement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tetec AGIndustry (pharma, biotech, devices)
- Collaborators
- Aesculap AG
- Study start
- Dec 2014 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cartilage defects in the hip joint | – | –NOVOCART® Inject Autologous Chondrocyte Implantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- specialist clinical centre
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
iHOT 33 (international HIP Outcome Tool) as a measurement of function and Quality of life
Time frame: 12 and 24 months
EQ-5D-5L (5-level EQ-5D ) as a measurement of function and Quality of life
Time frame: 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus-Peter Guenther, Prof. MD principal investigator
Universitätsklinikum Carls Gustav Carus der TU Dresden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Disease, run by Tetec AG at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.