Effect of an Alumina Free Device Surface on BMD in Patients Implanted With an SL-PLUS™ Femoral Stem for THA

September 20, 2021 updated by: Prof. Dr. med. Niklaus F. Friederich, Kantonsspital Baselland Bruderholz

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 years and older undergoing primary THA for primary or secondary osteoarthritis will be enrolled.

Exclusion Criteria:

  • Exclusion criteria were ongoing therapy with cortisone or medications influencing bone metabolism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: STD-SL-PLUS stem
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.
Device: SL-PLUS-Stem for total hip arthroplasty
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.
Active Comparator: NT-SL-PLUS Stem
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.
Device: SL-PLUS-Stem for total hip arthroplasty
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Measurements will be performed 7 days (baseline) after surgery
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).
Measurements will be performed 3 months postoperatively
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).
Measurements will be performed 6 months postoperatively
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).
Measurements will be performed 12 months postoperatively
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).
Measurements will be performed 24 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months
Time Frame: Measurements will be performed at 12 months postoperatively.
Assessment of radiographs for radiolucent lines (RLs) around the stem.
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.
Assessment of radiographs for radiolucent lines (RLs) around the stem.
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.
Assessment of radiographs for osteolysis around the stem.
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.
Assessment of radiographs for osteolysis around the stem.
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.
Assessment of radiographs for hypertrophies and atrophies around the stem.
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.
Assessment of radiographs for hypertrophies and atrophies around the stem.
Measurements will be performed at 24 months postoperatively.
Baseline WOMAC
Time Frame: Measurements will be performed 1 month preoperatively.
For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
Measurements will be performed 1 month preoperatively.
Change in WOMAC at 12 months
Time Frame: Measurements will be performed 12 months postoperatively
For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
Measurements will be performed 12 months postoperatively
Change in WOMAC at 24 months
Time Frame: Measurements will be performed 24 months postoperatively
For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
Measurements will be performed 24 months postoperatively
Baseline HHS
Time Frame: Measurements will be performed 1 month preoperatively.
For clinical scoring, the Harris Hip Score (HHS) will be assessed.
Measurements will be performed 1 month preoperatively.
Change in HHS at 12 months
Time Frame: Measurements will be performed 12 months postoperatively
For clinical scoring, the Harris Hip Score (HHS) will be assessed.
Measurements will be performed 12 months postoperatively
Change in HHS at 24 months
Time Frame: Measurements will be performed 24 months postoperatively
For clinical scoring, the Harris Hip Score (HHS) will be assessed.
Measurements will be performed 24 months postoperatively
Survival rates
Time Frame: Up to 24 months postoperatively.
THA survival rates and adverse events will be documented up to 24 months postoperatively.
Up to 24 months postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kantonsspital Baselland Bruderholz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Smith & Nephew, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Niklaus F. Friederich, MD, Prof., Kantonsspital Baselland Bruderholz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20052021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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