Hip OsteoarthritisNCT05053048
Effect of an Alumina Free Device Surface on BMD in Patients Implanted With an SL-PLUS™ Femoral Stem for THA
A study testing SL-PLUS-Stem for total hip arthroplasty in people with Hip Osteoarthritis, run by Kantonsspital Baselland Bruderholz.
Trial summary
Alumina particles from the grit blasting of Ti-alloy stems for hip arthroplasty are suspected to contribute to aseptic loosening. An alumina-reduced stem surface was hypothesized to improve osseointegration and show comparable short-term outcomes to those of a standard stem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- SL-PLUS-Stem for total hip arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2006to 31 May 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older undergoing primary THA for primary or secondary osteoarthritis will be enrolled.
Who cannot join
- Exclusion criteria were ongoing therapy with cortisone or medications influencing bone metabolism.
About this study
Official title: A Market Surveillance Study Assessing the Effect of an Alumina Free Device Surface on Bone Mineral Density in Patients Implanted With an SL-PLUS™ Femoral Stem for Total Hip Arthroplasty
Alumina particles from the grit blasting of Ti-alloy stems for hip arthroplasty are suspected to contribute to aseptic loosening. An alumina-reduced stem surface was hypothesized to improve osseointegration and show comparable short-term outcomes to those of a standard stem.
- Conditions
- Hip Osteoarthritis
- Being tested
- SL-PLUS-Stem for 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.
SL-PLUS-Stem for total hip arthroplastyDevice
Patients undergoing primary total hip arthroplasty are randomly assigned (1:1) to receive either an uncemented NT-SL-PLUS Stem (Smith\&Nephew Orthopaedics AG, Aarau, Switzerland) or a matching uncemented STD-SL-PLUS stem (Smith\&Nephew Orthopaedics AG, Aarau, Switzerland) in a blinded fashion.
| Study group | Role | What they receive |
|---|---|---|
| STD-SL-PLUS stem | Experimental | Rectangular SL straight stems made of titanium alloy (Ti-6Al-7Nb). The control stem (STD-SL-PLUS stem) underwent alumina grit blasting to reach the adequate roughness of 4-6 micron. Receives: Device: SL-PLUS-Stem for total hip arthroplasty |
| NT-SL-PLUS Stem | Active comparator | Rectangular SL straight stems made of titanium alloy (Ti-6Al-7Nb). The experimental stem (NT SL-PLUS) underwent alumina grit blasting to reach the adequate roughness of 4-6 micron. The surface of the NT SL-PLUS stem was thereafter additionally treated chemically by short-acid etching with HF and mechanically by dry ice blasting in order to loosen and remove the residual alumina particles up to 96% without changing the existing surface microtopography. Receives: Device: SL-PLUS-Stem for total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Bone mineral density by DEXA
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Measured: Measurements will be performed 7 days (baseline) after surgery
Change from baseline Bone mineral density by DEXA at 3 months
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Measured: Measurements will be performed 3 months postoperatively
Change from baseline Bone mineral density by DEXA at 6 months
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Measured: Measurements will be performed 6 months postoperatively
Change from baseline Bone mineral density by DEXA at 12 months
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Measured: Measurements will be performed 12 months postoperatively
Change from baseline Bone mineral density by DEXA at 24 months
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Measured: Measurements will be performed 24 months postoperatively
Secondary outcomes (13)
Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months
Assessment of radiographs for radiolucent lines (RLs) around the stem.
Measured: Measurements will be performed at 12 months postoperatively.
Rate of radiolucent lines on hip radiographs (AP and axial) at 24 months
Assessment of radiographs for radiolucent lines (RLs) around the stem.
Measured: Measurements will be performed at 24 months postoperatively.
Rate of osteolysis on hip radiographs (AP and axial) at 12 months
Assessment of radiographs for osteolysis around the stem.
Measured: Measurements will be performed at 12 months postoperatively.
Rate of osteolysis on hip radiographs (AP and axial) at 24 months
Assessment of radiographs for osteolysis around the stem.
Measured: Measurements will be performed at 24 months postoperatively.
Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 12 months
Assessment of radiographs for hypertrophies and atrophies around the stem.
Measured: Measurements will be performed at 12 months postoperatively.
Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 24 months.
Assessment of radiographs for hypertrophies and atrophies around the stem.
Measured: Measurements will be performed at 24 months postoperatively.
Baseline WOMAC
For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
Measured: Measurements will be performed 1 month preoperatively.
Change in WOMAC at 12 months
For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
Measured: Measurements will be performed 12 months postoperatively
Change in WOMAC at 24 months
For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
Measured: Measurements will be performed 24 months postoperatively
Baseline HHS
For clinical scoring, the Harris Hip Score (HHS) will be assessed.
Measured: Measurements will be performed 1 month preoperatively.
Change in HHS at 12 months
For clinical scoring, the Harris Hip Score (HHS) will be assessed.
Measured: Measurements will be performed 12 months postoperatively
Change in HHS at 24 months
For clinical scoring, the Harris Hip Score (HHS) will be assessed.
Measured: Measurements will be performed 24 months postoperatively
Survival rates
THA survival rates and adverse events will be documented up to 24 months postoperatively.
Measured: Up to 24 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Aug 2006
- Primary completion30 Sep 2008
- Study completion31 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlles trial, double-blind. Block randomization with block size 10.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baselland Bruderholz
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Principal investigator, Prof. Dr. med. Niklaus F. Friederich, Kantonsspital Baselland Bruderholz
- Investigators
- Niklaus F. Friederich, MD, Prof., Principal investigator, Kantonsspital Baselland Bruderholz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053048
- Sponsor's protocol ID
- 20052021
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moret CS, Masri SE, Schelker BL, Friederich NF, Hirschmann MT. Unexpected early loosening of rectangular straight femoral Zweymuller stems with an alumina-reduced surface after total hip arthroplasty-a prospective, double-blind, randomized controlled trial. J Orthop Traumatol. 2024 Mar 2;25(1):12. doi: 10.1186/s10195-023-00743-1.
PubMed 38430413
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Market Surveillance Study Assessing the Effect of an Alumina Free Device Surface on Bone Mineral Density in Patients Implanted With an SL-PLUS™ Femoral Stem for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05053048
- Acronym / sponsor ID
- 20052021
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kantonsspital Baselland BruderholzUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 1 Aug 2006 (actual)
- Primary completion
- 30 Sep 2008 (actual)
- Study completion
- 31 May 2012 (actual)
- First posted
- 22 Sep 2021 (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.
Alumina particles from the grit blasting of Ti-alloy stems for hip arthroplasty are suspected to contribute to aseptic loosening. An alumina-reduced stem surface was hypothesized to improve osseointegration and show comparable short-term outcomes to those of a standard stem.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlles trial, double-blind. Block randomization with block size 10.
| Arm | Type | Receives |
|---|---|---|
| STD-SL-PLUS stem | Experimental | Device: SL-PLUS-Stem for total hip arthroplastyRectangular SL straight stems made of titanium alloy (Ti-6Al-7Nb). The control stem (STD-SL-PLUS stem) underwent alumina grit blasting to reach the adequate roughness of 4-6 micron. |
| NT-SL-PLUS Stem | Active comparator | Device: SL-PLUS-Stem for total hip arthroplastyRectangular SL straight stems made of titanium alloy (Ti-6Al-7Nb). The experimental stem (NT SL-PLUS) underwent alumina grit blasting to reach the adequate roughness of 4-6 micron. The surface of the NT SL-PLUS stem was thereafter additionally treated chemically by short-acid etching with HF and mechanically by dry ice blasting in order to loosen and remove the residual alumina particles up to 96% without changing the existing surface microtopography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years and older undergoing primary THA for primary or secondary osteoarthritis will be enrolled.
Key exclusion criteria (1 listed)
- Exclusion criteria were ongoing therapy with cortisone or medications influencing bone metabolism.
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 |
|---|---|---|
| SL-PLUS-Stem for total hip arthroplastyPatients undergoing primary total hip arthroplasty are randomly assigned (1:1) to receive either an uncemented NT-SL-PLUS Stem (Smith\&Nephew Orthopaedics AG, Aarau, Switzerland) or a matching uncemented STD-SL-PLUS stem (Smith\&Nephew Orthopaedics AG, Aarau, Switzerland) in a blinded fashion. | Device | NT-SL-PLUS Stem, STD-SL-PLUS stem |
Primary outcome
Baseline Bone mineral density by DEXA
Time frame: Measurements will be performed 7 days (baseline) after surgery
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Change from baseline Bone mineral density by DEXA at 3 months
Time frame: Measurements will be performed 3 months postoperatively
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Change from baseline Bone mineral density by DEXA at 6 months
Time frame: Measurements will be performed 6 months postoperatively
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Change from baseline Bone mineral density by DEXA at 12 months
Time frame: Measurements will be performed 12 months postoperatively
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
Change from baseline Bone mineral density by DEXA at 24 months
Time frame: Measurements will be performed 24 months postoperatively
Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).
13 secondary outcomes
Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months
Time frame: Measurements will be performed at 12 months postoperatively.
Rate of radiolucent lines on hip radiographs (AP and axial) at 24 months
Time frame: Measurements will be performed at 24 months postoperatively.
Rate of osteolysis on hip radiographs (AP and axial) at 12 months
Time frame: Measurements will be performed at 12 months postoperatively.
Rate of osteolysis on hip radiographs (AP and axial) at 24 months
Time frame: Measurements will be performed at 24 months postoperatively.
Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 12 months
Time frame: Measurements will be performed at 12 months postoperatively.
Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 24 months.
Time frame: Measurements will be performed at 24 months postoperatively.
Baseline WOMAC
Time frame: Measurements will be performed 1 month preoperatively.
Change in WOMAC at 12 months
Time frame: Measurements will be performed 12 months postoperatively
Change in WOMAC at 24 months
Time frame: Measurements will be performed 24 months postoperatively
Baseline HHS
Time frame: Measurements will be performed 1 month preoperatively.
Change in HHS at 12 months
Time frame: Measurements will be performed 12 months postoperatively
Change in HHS at 24 months
Time frame: Measurements will be performed 24 months postoperatively
Survival rates
Time frame: Up to 24 months postoperatively.
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 22 Sep 2021.
- Derived from this study: PubMed 38430413Moret CS, Masri SE, Schelker BL, Friederich NF, Hirschmann MT. Unexpected early loosening of rectangular straight femoral Zweymuller stems with an alumina-reduced surface after total hip arthroplasty-a prospective, double-blind, randomized controlled trial. J Orthop Traumatol. 2024 Mar 2;25(1):12. doi: 10.1186/s10195-023-00743-1.
- 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.
Niklaus F. Friederich, MD, Prof. principal investigator
Kantonsspital Baselland Bruderholz
Questions about this trial
What is this clinical trial studying?
A study testing SL-PLUS-Stem for total hip arthroplasty in people with Hip Osteoarthritis, run by Kantonsspital Baselland Bruderholz.
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 1 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 22 Sep 2021. 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?
Baseline Bone mineral density by DEXA (time frame: Measurements will be performed 7 days (baseline) after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05053048, which also lists 1 linked publication.
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 22 Sep 2021.