CoxarthrosisPhase 4SL-PLUSNCT01435850
Safety and Efficacy of the SL PLUS and the SL PLUS MIA Hip Stem
A Phase 4 study testing primary total hip arthroplasty in people with Coxarthrosis, run by Smith & Nephew Orthopaedics AG at 1 site in France.
Trial summary
Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL PLUS (study group). We compare primary and secondary stability of both hip stems for radiographic outcome using EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coxarthrosis
- What is being tested?
- primary total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Nov 2014
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient needs primary total hip arthroplasty with SL-PLUS (standard or lateralized depending on bone morphology)
- Age at surgery : 18-80 years old
- Patient has social security number
- Patient gives Informed Consent (IC) by signing the IC form and patient is willing to attend the follow-up control
Who cannot join
- Patient's BMI is over 35
- Patient has bone tumors that can affect implant stability
- Patient needs cortical steroid treatment
- Patient needs hip revision arthroplasty
- Patient has general inflammation that could affect bone quality
- Patients classified Charnley C
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Enfoncement de la Tige SL-PLUS et de la Tige SL-PLUS MIA:Etude Comparative"
Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL PLUS (study group).
We compare primary and secondary stability of both hip stems for radiographic outcome using EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.
Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings.
Read the detailed description
This study is a monocentric study, randomized and controlled including two types of hip stems: SL PLUS MIA (control group) and SL PLUS (study group).
Each group will include 45 patients where a number of 5 patients for each group calculated extra in case of loss.
Patients will be followed after
- 6 weeks
- 6 months
- 12 months
- 24 months. Radiographs are taken in a-p and lateral view using a standard protocol. Primary and secondary stability of both hip stems will be analyzed using the EBRA software (Ein-Bild-Roentgen-Analyse, University of Innsbruck, Austria) after the completion of the two year follow-up.
Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings such as radiolucent lines.
- Conditions
- Coxarthrosis
- Being tested
- primary total hip arthroplasty
- Keywords
- hip arthroplasty, primary stability, secondary stability, EBRA
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary total hip arthroplastyProcedure or surgery
Also called SL-PLUS, SL-PLUS MIA, Lateralized hip stem
All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.
| Study group | Role | What they receive |
|---|---|---|
| HIP STEM SL PLUS | Sham comparator | study group Receives: Procedure: primary total hip arthroplasty |
| HIP STEM SL PLUS MIA | Active comparator | control group Receives: Procedure: primary total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of primary total hip arthroplasty
Study compares the stability of two types of hip stems using the Femoral Component Analysis (FCA-EBRA)method. 4 images of a-p pelvic view will be collected over a 2-year period: at 6 weeks, 6, 12 and 24 months.
Measured: 24 months
Secondary outcomes (2)
Oxford Hip Score
According to Delaunay C, Cross-cultural adaptations of the Oxford-12 HIP score to the French speaking population, Orthop Traumatol Surg Res. 2009 Apr;95(2):89-99. Epub 2009 Apr 3.
Oxford Hip Score will be measured pre-operatively, after 6 weeks, 6, 12 and 24 months.
Measured: 24 months
Harris Hip Score
Harris Hip Score will be measured pre-operatively, after 6, 12 and 24 months. No measurement after 6 weeks.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startApr 2009
- Primary completionOct 2012
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henri Migaud, MD, Pr., Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435850
- Sponsor's protocol ID
- D10056-2-F
- Acronym
- SL-PLUS
- Status last verified
- Apr 2015
- First submitted
- 13 Sep 2011
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Enfoncement de la Tige SL-PLUS et de la Tige SL-PLUS MIA:Etude Comparative"
- ClinicalTrials.gov ID
- NCT01435850
- Acronym / sponsor ID
- SL-PLUS / D10056-2-F
- Conditions
- Coxarthrosis
- Keywords
- hip arthroplasty, primary stability, secondary stability, EBRA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Sep 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.
Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL PLUS (study group).
We compare primary and secondary stability of both hip stems for radiographic outcome using EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.
Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings.
Detailed description
This study is a monocentric study, randomized and controlled including two types of hip stems: SL PLUS MIA (control group) and SL PLUS (study group).
Each group will include 45 patients where a number of 5 patients for each group calculated extra in case of loss.
Patients will be followed after
- 6 weeks
- 6 months
- 12 months
- 24 months. Radiographs are taken in a-p and lateral view using a standard protocol. Primary and secondary stability of both hip stems will be analyzed using the EBRA software (Ein-Bild-Roentgen-Analyse, University of Innsbruck, Austria) after the completion of the two year follow-up.
Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings such as radiolucent lines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIP STEM SL PLUS | Sham comparator | Procedure: primary total hip arthroplastystudy group |
| HIP STEM SL PLUS MIA | Active comparator | Procedure: primary total hip arthroplastycontrol group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient needs primary total hip arthroplasty with SL-PLUS (standard or lateralized depending on bone morphology)
- Age at surgery : 18-80 years old
- Patient has social security number
- Patient gives Informed Consent (IC) by signing the IC form and patient is willing to attend the follow-up control
Key exclusion criteria (6 listed)
- Patient's BMI is over 35
- Patient has bone tumors that can affect implant stability
- Patient needs cortical steroid treatment
- Patient needs hip revision arthroplasty
- Patient has general inflammation that could affect bone quality
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 |
|---|---|---|
| primary total hip arthroplastyAlso: SL-PLUS, SL-PLUS MIA, Lateralized hip stemAll patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed. | Procedure or surgery | HIP STEM SL PLUS, HIP STEM SL PLUS MIA |
Primary outcome
Stability of primary total hip arthroplasty
Time frame: 24 months
Study compares the stability of two types of hip stems using the Femoral Component Analysis (FCA-EBRA)method. 4 images of a-p pelvic view will be collected over a 2-year period: at 6 weeks, 6, 12 and 24 months.
2 secondary outcomes
Oxford Hip Score
Time frame: 24 months
Harris Hip Score
Time frame: 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 3 Apr 2015.
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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.
Henri Migaud, MD, Pr. principal investigator
University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing primary total hip arthroplasty in people with Coxarthrosis, run by Smith & Nephew Orthopaedics AG 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 4 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: finished, as of the sponsor's last update on 3 Apr 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Stability of primary total hip arthroplasty (time frame: 24 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 3 Apr 2015.