Primary Total Hip ArthroplastySL-PLUS MIANCT04122157
Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem
An observational study of Primary Total Hip Arthroplasty, run by Smith & Nephew Orthopaedics AG.
Trial summary
Summary from initial protocol Goal: Validation of the uncoated SL-PLUS® MIA stem within an observation study Study design: prospective, single-center, observational, non-comparative study Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants) Intervention (if applicable): Implantation of a total hip… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Total Hip Arthroplasty
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2007to 11 Nov 2019
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)
Who may be able to join
- Patients with primary or secondary hip osteoarthritis
- Patients scheduled for a first implantation
- Age at the time of surgery 40-80 years
Who cannot join
- Destruction of the acetabulum
- Deformation of the hip joint
- Deformation of the proximal femur
- Revision of failed hip endoprostheses
- Acute or recent infection of the joint or its surrounding region
- Acute or chronic systemic infections
Show all 13Show fewer
- Marked atrophy or deformation of the upper femur
- Muscle atrophy or a neuromuscular disease
- Pathological fractures
- Per- to subtrochanteric fractures
- Conditions that would prevent secure anchoring of the hip prosthesis
- Obese patients with a BMI >35
- Patients not expected to have a successful rehabilitation
About this study
Summary from initial protocol
Goal: Validation of the uncoated SL-PLUS® MIA stem within an observation study
Read more
Study design: prospective, single-center, observational, non-comparative study
Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)
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, implant-related complications, revisions; patient questionnaire (WOMAC)
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. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the benefit for the patients from the participation in the study is currently not yet foreseeable.
- Conditions
- Primary Total Hip Arthroplasty
- Keywords
- Uncoated SL PLUS® MIA stem
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival, Kaplan Meier
Survival rate: Rate of hip implants in situ after 10 years of follow-up.
Measured: up to 10 years after implantation
Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge
Rate of hip implant experiencing intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge.
Rate of hip implants with 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
Rate of hip implants experiencing Postoperative AE up to 10 years after the surgery Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Measured: up to 10 years after implantation
Secondary outcomes (2)
Radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.
Rate of hip implants with radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.
Measured: up to 10 years after implantation
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.The score considers information on pain, function and range of motion. The scale ranges from 0 - 100 whereas, a higher score indicates a favorable outcome.
Measured: up to 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 posted10 Oct 2019
- Study start22 Jul 2007
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinzenz v. Auersperg, Prim. Dr., Principal investigator, Orthopädie LKH Steyr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122157
- Sponsor's protocol ID
- D10055-2
- Acronym
- SL-PLUS MIA
- Status last verified
- Feb 2021
- First submitted
- 8 Oct 2019
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem
- ClinicalTrials.gov ID
- NCT04122157
- Acronym / sponsor ID
- SL-PLUS MIA / D10055-2
- Conditions
- Primary Total Hip Arthroplasty
- Keywords
- Uncoated SL PLUS® MIA stem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2007 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 10 Oct 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 uncoated SL-PLUS® MIA stem within an observation study
Study design: prospective, single-center, observational, non-comparative study
Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)
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, implant-related complications, revisions; patient questionnaire (WOMAC)
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. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the 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
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 135 consecutive cases (uncoated SL-PLUS® MIA implants)
Key inclusion criteria (3 listed)
- Patients with primary or secondary hip osteoarthritis
- Patients scheduled for a first implantation
- Age at the time of surgery 40-80 years
Key exclusion criteria (13 listed)
- Destruction of the acetabulum
- Deformation of the hip joint
- Deformation of the proximal femur
- Revision of failed hip endoprostheses
- Acute or recent infection of the joint or its surrounding region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival, Kaplan Meier
Time frame: up to 10 years after implantation
Survival rate: Rate of hip implants in situ after 10 years of follow-up.
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)
Rate of hip implant experiencing intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge. Rate of hip implants with Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Postoperative AE up to 10 years after the surgery
Time frame: up to 10 years after implantation
Rate of hip implants experiencing Postoperative AE up to 10 years after the surgery Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
2 secondary outcomes
Radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.
Time frame: up to 10 years after implantation
Harris Hip Score
Time frame: up to 10 years after implantation
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 6 Jan 2026.
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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.
Vinzenz v. Auersperg, Prim. Dr. principal investigator
Orthopädie LKH Steyr
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Total Hip Arthroplasty, run by Smith & Nephew Orthopaedics AG.
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 3 inclusion and 13 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Survival, Kaplan Meier (time frame: up to 10 years after implantation). The study lists 3 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 6 Jan 2026.