Degenerative Joint Disease of the HipNCT01982266
A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip
A study testing GRADION™ Hip Total Cartilage Replacement (TCR)™ in people with Degenerative Joint Disease of the Hip, run by Biomimedica, Inc at 1 site in Netherlands.
Trial summary
This is a prospective, multicenter, single arm feasibility study of the safety and performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require cartilage replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Joint Disease of the Hip
- What is being tested?
- GRADION™ Hip Total Cartilage Replacement (TCR)™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2013to Aug 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary hip surgery for Noninflammatory Degenerative Joint Disease (NIDJD) such as osteo/degenerative arthritis, and is indicated for cartilage replacement
- Skeletally mature or at least 18 years of age and has normal anatomy
- Patient signs the Informed Consent form
- Failed medical management
- There will be size limitations on patients also - available size range is 46mm-54mm.
Who cannot join
- Allergic to polyether urethane, sodium polyacrylate, bone cement or any of its components
- Previous fusion, acute femoral neck fracture and/or above knee amputation
- Revision of any previous hip procedure
- Slipped capital femoral epiphysis (SCFE)
- Rheumatoid arthritis
- AVN
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, multicenter, single arm feasibility study of the safety and performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require cartilage replacement.
- Conditions
- Degenerative Joint Disease of the Hip
- Being tested
- GRADION™ Hip Total Cartilage Replacement (TCR)™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRADION™ Hip Total Cartilage Replacement (TCR)™Device
| Study group | Role | What they receive |
|---|---|---|
| GRADION™ Hip Total Cartilage Replacement (TCR)™ | Experimental | Not described Receives: Device: GRADION™ Hip Total Cartilage Replacement (TCR)™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Device failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint Disease of the HipStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomimedica, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982266
- Sponsor's protocol ID
- EP052
- Status last verified
- May 2016
- First submitted
- 1 Nov 2013
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip
- ClinicalTrials.gov ID
- NCT01982266
- Acronym / sponsor ID
- EP052
- Conditions
- Degenerative Joint Disease of the Hip
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device failure
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Biomimedica, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Nov 2013 (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.
This is a prospective, multicenter, single arm feasibility study of the safety and performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require cartilage replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GRADION™ Hip Total Cartilage Replacement (TCR)™ | Experimental | Device: GRADION™ Hip Total Cartilage Replacement (TCR)™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary hip surgery for Noninflammatory Degenerative Joint Disease (NIDJD) such as osteo/degenerative arthritis, and is indicated for cartilage replacement
- Skeletally mature or at least 18 years of age and has normal anatomy
- Patient signs the Informed Consent form
- Failed medical management
- There will be size limitations on patients also - available size range is 46mm-54mm.
Key exclusion criteria (6 listed)
- Allergic to polyether urethane, sodium polyacrylate, bone cement or any of its components
- Previous fusion, acute femoral neck fracture and/or above knee amputation
- Revision of any previous hip procedure
- Slipped capital femoral epiphysis (SCFE)
- Rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRADION™ Hip Total Cartilage Replacement (TCR)™ | Device | GRADION™ Hip Total Cartilage Replacement (TCR)™ |
Primary outcome
Adverse events
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Device failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRADION™ Hip Total Cartilage Replacement (TCR)™ in people with Degenerative Joint Disease of the Hip, run by Biomimedica, Inc at 1 site in Netherlands.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 was stopped early (reason given: Device failure). Results are not available in the source record.
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?
Adverse events (time frame: 6 months). 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 18 May 2016.