Primary Total Hip ArthroplastySL-Plus HA MIANCT04036071
Clinical Observation Study of the Hydroxylapatite-coated SLPLUS™MIA Hip Shaft
An observational study of Primary Total Hip Arthroplasty, run by Smith & Nephew Orthopaedics AG at 3 sites in Austria.
Trial summary
Summary from initial protocol Goal: Validation of the HA (hydroxylapatite) coated SLPLUS ™ MIA stem within an observation study Study design: prospective, multicenter, observational, noncomparative study Study population: 300 consecutive cases (HA-coated implants), 60 cases per study site. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Total Hip Arthroplasty
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 3 sitesAustria
- Study dates
- 15 May 2009to 27 Oct 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients requiring primary total hip arthroplasty of the affected side (unilateral or bilateral).
Who may be able to join
- Primary total hip endoprosthesis of the side affected (unilateral or bilateral)
- Patient shall be provided with a HA coated SLPLUS™ MIA stem
- Patient has no general medical contraindications regarding the surgery
- Signed informed consent form for the participation in the study
- X-ray examinations are possible
- Patient is willing to participate in the post-operative follow-up program
- Age: 18-75 years
Who cannot join
- Previous failed hip joint surgery (endoprosthesis) of the side affected
- Previous infections in the joint affected; systemic infections
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Orthopädische Landesklinik Salzburg
Salzburg, 5020
Orthopädie LKH Steyr
Steyr, 4400
Orthopädisches Krankenhaus Gersthof
Vienna
About this study
Summary from initial protocol Goal: Validation of the HA (hydroxylapatite) coated SLPLUS
™ MIA stem within an observation study Study design: prospective, multicenter, observational, noncomparative study Study population: 300 consecutive cases (HA-coated implants), 60 cases per study site. Intervention (if applicable): Implantation of a total hip endoprosthesis Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration. Clinical: Harris Hip Score, HOOS Score, EQ-5D, implant-related complications, revisions Type and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. In addition, study patients are asked to provide information on their general state of health and the condition of their hip in two questionnaires. These clinical and radiological follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the direct benefit for the patients from the participation in the study is currently not yet foreseeable.
- Conditions
- Primary Total Hip Arthroplasty
- Being tested
- Total Hip Arthroplasty
- Keywords
- HA (hydroxylapatite) coated SL-PLUS™ MIA stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyDevice
Total Hip Arthroplasty using the SL-PLUS™ MIA cement free hip stem
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty
Measured: up 10 years after implantation
WOMAC Osteoarthritis Index
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:[1]
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
Measured: up 10 years after implantation
EuroQuol-5D questionnaire
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal
Measured: up 10 years after implantation
Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge
Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Measured: up to patient's discharge from the hospital / clinic (from surgery up to 7 days after surgery)
Postoperative AE up to 10 years after the surgery
Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Measured: up 10 years after implantation
Survival, Kaplan Meier
Hip implants in situ after 10 years of follow-up
Measured: up 10 years after implantation
Secondary outcomes (1)
Radiographic changes defined as radiolucent lines,osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.
Measured: up 10 years after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start15 May 2009
- Primary completion27 Oct 2020
- Study completion27 Oct 2020
Why it stopped: Business reasons. High subject attrition at the 10-year time point leading to loss of statistical power and data value. Decision finalised: 05May2023.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Total Hip ArthroplastyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- K Zweymuller, Study chair, Orthopädisches Krankenhaus GersthofVinzenz v. Auersperg, Principal investigator, Orthopädie LKH Steyr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036071
- Sponsor's protocol ID
- D10080-2
- Acronym
- SL-Plus HA MIA
- Status last verified
- May 2023
- First submitted
- 10 Jul 2019
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation Study of the Hydroxylapatite-coated SLPLUS™MIA Hip Shaft
- ClinicalTrials.gov ID
- NCT04036071
- Acronym / sponsor ID
- SL-Plus HA MIA / D10080-2
- Conditions
- Primary Total Hip Arthroplasty
- Keywords
- HA (hydroxylapatite) coated SL-PLUS™ MIA stem
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business reasons. High subject attrition at the 10-year time point leading to loss of statistical power and data value. Decision finalised: 05May2023.
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- 15 May 2009 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 27 Oct 2020 (actual)
- First posted
- 29 Jul 2019 (actual)
- 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.
Summary from initial protocol Goal: Validation of the HA (hydroxylapatite) coated SLPLUS
™ MIA stem within an observation study Study design: prospective, multicenter, observational, noncomparative study Study population: 300 consecutive cases (HA-coated implants), 60 cases per study site. Intervention (if applicable): Implantation of a total hip endoprosthesis Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration. Clinical: Harris Hip Score, HOOS Score, EQ-5D, implant-related complications, revisions Type and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. In addition, study patients are asked to provide information on their general state of health and the condition of their hip in two questionnaires. These clinical and radiological follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the direct benefit for the patients from the participation in the study is currently not yet foreseeable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring primary total hip arthroplasty of the affected side (unilateral or bilateral).
Key inclusion criteria (7 listed)
- Primary total hip endoprosthesis of the side affected (unilateral or bilateral)
- Patient shall be provided with a HA coated SLPLUS™ MIA stem
- Patient has no general medical contraindications regarding the surgery
- Signed informed consent form for the participation in the study
- X-ray examinations are possible
Key exclusion criteria (2 listed)
- Previous failed hip joint surgery (endoprosthesis) of the side affected
- Previous infections in the joint affected; systemic infections
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 ArthroplastyTotal Hip Arthroplasty using the SL-PLUS™ MIA cement free hip stem | Device | – |
Primary outcome
Harris Hip Score
Time frame: up 10 years after implantation
The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty
WOMAC Osteoarthritis Index
Time frame: up 10 years after implantation
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:[1] Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
EuroQuol-5D questionnaire
Time frame: up 10 years after implantation
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal
Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge
Time frame: up to patient's discharge from the hospital / clinic (from surgery up to 7 days after surgery)
Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Postoperative AE up to 10 years after the surgery
Time frame: up 10 years after implantation
Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Survival, Kaplan Meier
Time frame: up 10 years after implantation
Hip implants in situ after 10 years of follow-up
1 secondary outcome
Radiographic changes defined as radiolucent lines,osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.
Time frame: up 10 years after implantation
Results and safety
The study was stopped early (reason given: Business reasons. High subject attrition at the 10-year time point leading to loss of statistical power and data value. Decision finalised: 05May2023.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- 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.
K Zweymuller study chair
Orthopädisches Krankenhaus Gersthof
Vinzenz v. Auersperg principal investigator
Orthopädie LKH Steyr
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 Primary Total Hip Arthroplasty, run by Smith & Nephew Orthopaedics AG at 3 sites in Austria.
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 2 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 1 Jun 2023. 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 Austria. 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: Business reasons. High subject attrition at the 10-year time point leading to loss of statistical power and data value. Decision finalised: 05May2023.). 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?
Harris Hip Score (time frame: up 10 years after implantation). The study lists 6 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 1 Jun 2023.