Hip Arthroplasty ReplacementPhase 1/2NCT01454271
Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate
A Phase 1/2 study testing Total Hip Arthroplasty Replacement in people with Hip Arthroplasty Replacement, run by Societe ACTIVBIOMAT at 1 site in France.
Trial summary
The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to be less than 1% but remains a severe and costly complication, source of morbidity and even mortality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hip Arthroplasty Replacement
- What is being tested?
- Total Hip Arthroplasty Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age less than 75 years old
- Aetiologies for THA : primary osteoarthritis, inflammatory diseases,Osteonecrosis
Who cannot join
- Previous infectious hip arthritis
- Previous surgeries on the operated hip
- Revision of THA
Trial locations and contacts
1 site in 1 country.
France1 site
Ambroise Paré Hospital. Orthopaedic surgery department
Boulogne-Billancourt, Île-de-France Region, 92100
About this study
The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to be less than 1% but remains a severe and costly complication, source of morbidity and even mortality. The "biofilm" forms very early after the bacterial contamination of the prosthesis and poses a number of clinical challenges due to his resistance to immune defence mechanisms and antibiotics. Preventive strategies are needed. The poly sodium styrene sulfonate (pNaSS) is a bioactive polymer. In vitro and in vivo studies showed that poly sodium styrene sulfonate grafted on titane surfaces reduce significantly the bacterial adhesion. They also proved his biocompatibility and osseous-integration.
- Conditions
- Hip Arthroplasty Replacement
- Being tested
- Total Hip Arthroplasty Replacement
- Keywords
- Total Hip arthroplasty, Hip Osteoarthritis, Infection after Total Hip Arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip Arthroplasty ReplacementProcedure or surgery
Total Hip Arthroplasty Replacement
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Arthroplasty CERAFIT® grafted | Experimental | Not described Receives: Procedure: Total Hip Arthroplasty Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral component osseous-integration
Scoring system of Engh
Measured: 1 year after surgery
Secondary outcomes (2)
Infection rate
Infection (yes/no) :
Clinical, biological or radiological THA infection signs. In the case of infection suspicion, hip aspiration will be performed with joint fluid culture
Measured: 1 year after surgery
Quality of Life
SF-36 score
Measured: One, three, six and twelve months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
Why it stopped: We have decided to design a comparative study which is ongoing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Arthroplasty ReplacementStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societe ACTIVBIOMAT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Hardy, Ph.D., Principal investigator, Ambroise Paré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454271
- Sponsor's protocol ID
- CERAVERBIO11
- Other IDs
- 2011-A00597-34
- Status last verified
- Aug 2018
- First submitted
- 14 Oct 2011
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate
- ClinicalTrials.gov ID
- NCT01454271
- Acronym / sponsor ID
- CERAVERBIO11
- Conditions
- Hip Arthroplasty Replacement
- Keywords
- Total Hip arthroplasty, Hip Osteoarthritis, Infection after Total Hip Arthroplasty
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We have decided to design a comparative study which is ongoing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Societe ACTIVBIOMATIndustry (pharma, biotech, devices)
- First posted
- 18 Oct 2011 (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.
The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to be less than 1% but remains a severe and costly complication, source of morbidity and even mortality. The "biofilm" forms very early after the bacterial contamination of the prosthesis and poses a number of clinical challenges due to his resistance to immune defence mechanisms and antibiotics. Preventive strategies are needed. The poly sodium styrene sulfonate (pNaSS) is a bioactive polymer. In vitro and in vivo studies showed that poly sodium styrene sulfonate grafted on titane surfaces reduce significantly the bacterial adhesion. They also proved his biocompatibility and osseous-integration.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Hip Arthroplasty CERAFIT® grafted | Experimental | Procedure: Total Hip Arthroplasty Replacement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age less than 75 years old
- Aetiologies for THA : primary osteoarthritis, inflammatory diseases,Osteonecrosis
Key exclusion criteria (3 listed)
- Previous infectious hip arthritis
- Previous surgeries on the operated hip
- Revision of THA
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 |
|---|---|---|
| Total Hip Arthroplasty ReplacementTotal Hip Arthroplasty Replacement | Procedure or surgery | Total Hip Arthroplasty CERAFIT® grafted |
Primary outcome
Femoral component osseous-integration
Time frame: 1 year after surgery
Scoring system of Engh
2 secondary outcomes
Infection rate
Time frame: 1 year after surgery
Quality of Life
Time frame: One, three, six and twelve months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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The restor3d Outcomes Registry
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Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
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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.
Philippe Hardy, Ph.D. principal investigator
Ambroise Paré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Total Hip Arthroplasty Replacement in people with Hip Arthroplasty Replacement, run by Societe ACTIVBIOMAT at 1 site in France.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Aug 2018. 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 France. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Femoral component osseous-integration (time frame: 1 year after surgery). 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 14 Aug 2018.