Total Hip ArthroplastyCOCYCOXNCT02525770
Comparative Study of the Wear of Uncemented Acetabular Conventional Polyethylene and X3 in Total Hip Replacement, for Stereo-radiographic Analysis
A study testing radiostereometric analysis (RSA) in people with Total Hip Arthroplasty, run by University Hospital, Caen at 1 site in France.
Trial summary
Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the few early complications (acute infections and dislocations), the patient made a PTH can be assured of a significant improvement in its function and its short-term quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- radiostereometric analysis (RSA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jul 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (18-70 years) with hip disease necessitating the establishment of a total hip replacement
Who cannot join
- Patient aged 71 or more
- Pregnant woman or wishing to be for the duration of the study
- Resumption of total hip replacement, or cephalic prosthesis cups
- Primary or secondary malignant neoplasm of the hip
- Protected adult patient
Trial locations and contacts
1 site in 1 country.
About this study
Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the few early complications (acute infections and dislocations), the patient made a PTH can be assured of a significant improvement in its function and its short-term quality of life. However, clinical studies and records have shown that the lifetime of these implants was limited. The main cause of failure is the "aseptic loosening" influenced by many factors, foremost of which is due to periprosthetic osteolysis debris. This is a major concern for orthopedic surgeons loosening leads, in most cases, the recovery, the importance of osteolysis is a major cause of difficulties and poorer results.
The main objective of the study is to compare, 2 years after the intervention, the penetration of the femoral head in the polyethylene and X3 in the acetabulum in N2VAC® conventional polyethylene.
- Conditions
- Total Hip Arthroplasty
- Being tested
- radiostereometric analysis (RSA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiostereometric analysis (RSA)Device
| Study group | Role | What they receive |
|---|---|---|
| acetabular liner in X3 polyethylene | Active comparator | acetabular in X3 polyethylene Receives: Device: radiostereometric analysis (RSA) |
| acetabular liner in N2VAC® conventional polyethylene | Active comparator | hip replacement with acetabular liner in N2VAC® conventional polyethylene Receives: Device: radiostereometric analysis (RSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration of the femoral head in the polyethylene measure in millimeters
The median head penetration in millimeters
Measured: change over baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startJun 2010
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525770
- Sponsor's protocol ID
- 09-018
- Acronym
- COCYCOX
- Status last verified
- Jul 2016
- First submitted
- 6 Aug 2015
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Wear of Uncemented Acetabular Conventional Polyethylene and X3 in Total Hip Replacement, for Stereo-radiographic Analysis
- ClinicalTrials.gov ID
- NCT02525770
- Acronym / sponsor ID
- COCYCOX / 09-018
- Conditions
- Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2016 (estimated)
- First posted
- 17 Aug 2015 (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.
Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the few early complications (acute infections and dislocations), the patient made a PTH can be assured of a significant improvement in its function and its short-term quality of life. However, clinical studies and records have shown that the lifetime of these implants was limited. The main cause of failure is the "aseptic loosening" influenced by many factors, foremost of which is due to periprosthetic osteolysis debris. This is a major concern for orthopedic surgeons loosening leads, in most cases, the recovery, the importance of osteolysis is a major cause of difficulties and poorer results.
The main objective of the study is to compare, 2 years after the intervention, the penetration of the femoral head in the polyethylene and X3 in the acetabulum in N2VAC® conventional polyethylene.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetabular liner in X3 polyethylene | Active comparator | Device: radiostereometric analysis (RSA)acetabular in X3 polyethylene |
| acetabular liner in N2VAC® conventional polyethylene | Active comparator | Device: radiostereometric analysis (RSA)hip replacement with acetabular liner in N2VAC® conventional polyethylene |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient (18-70 years) with hip disease necessitating the establishment of a total hip replacement
Key exclusion criteria (5 listed)
- Patient aged 71 or more
- Pregnant woman or wishing to be for the duration of the study
- Resumption of total hip replacement, or cephalic prosthesis cups
- Primary or secondary malignant neoplasm of the hip
- Protected adult patient
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 |
|---|---|---|
| radiostereometric analysis (RSA) | Device | acetabular liner in N2VAC® conventional polyethylene, acetabular liner in X3 polyethylene |
Primary outcome
Penetration of the femoral head in the polyethylene measure in millimeters
Time frame: change over baseline and 2 years
The median head penetration in millimeters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 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 radiostereometric analysis (RSA) in people with Total Hip Arthroplasty, run by University Hospital, Caen 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Jul 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 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.
Are results available for this study?
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?
Penetration of the femoral head in the polyethylene measure in millimeters (time frame: change over baseline and 2 years). 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 28 Jul 2016.