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

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SL-PLUS-Stem for total hip arthroplasty
Sponsored by
Kantonsspital Baselland Bruderholz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    STD-SL-PLUS stem

    NT-SL-PLUS Stem

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).
    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).
    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).
    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).
    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).

    Secondary Outcome Measures

    Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months
    Assessment of radiographs for radiolucent lines (RLs) around the stem.
    Rate of radiolucent lines on hip radiographs (AP and axial) at 24 months
    Assessment of radiographs for radiolucent lines (RLs) around the stem.
    Rate of osteolysis on hip radiographs (AP and axial) at 12 months
    Assessment of radiographs for osteolysis around the stem.
    Rate of osteolysis on hip radiographs (AP and axial) at 24 months
    Assessment of radiographs for osteolysis around the stem.
    Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 12 months
    Assessment of radiographs for hypertrophies and atrophies around the stem.
    Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 24 months.
    Assessment of radiographs for hypertrophies and atrophies around the stem.
    Baseline WOMAC
    For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
    Change in WOMAC at 12 months
    For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
    Change in WOMAC at 24 months
    For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
    Baseline HHS
    For clinical scoring, the Harris Hip Score (HHS) will be assessed.
    Change in HHS at 12 months
    For clinical scoring, the Harris Hip Score (HHS) will be assessed.
    Change in HHS at 24 months
    For clinical scoring, the Harris Hip Score (HHS) will be assessed.
    Survival rates
    THA survival rates and adverse events will be documented up to 24 months postoperatively.

    Full Information

    First Posted
    August 25, 2021
    Last Updated
    September 20, 2021
    Sponsor
    Kantonsspital Baselland Bruderholz
    Collaborators
    Smith & Nephew, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05053048
    Brief Title
    Effect of an Alumina Free Device Surface on BMD in Patients Implanted With an SL-PLUS™ Femoral Stem for THA
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2006 (Actual)
    Primary Completion Date
    September 30, 2008 (Actual)
    Study Completion Date
    May 31, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kantonsspital Baselland Bruderholz
    Collaborators
    Smith & Nephew, Inc.

    4. Oversight

    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

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomised controlles trial, double-blind. Block randomization with block size 10.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    STD-SL-PLUS stem
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    NT-SL-PLUS Stem
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    SL-PLUS-Stem for total hip arthroplasty
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Baseline Bone mineral density by DEXA
    Description
    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).
    Time Frame
    Measurements will be performed 7 days (baseline) after surgery
    Title
    Change from baseline Bone mineral density by DEXA at 3 months
    Description
    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).
    Time Frame
    Measurements will be performed 3 months postoperatively
    Title
    Change from baseline Bone mineral density by DEXA at 6 months
    Description
    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).
    Time Frame
    Measurements will be performed 6 months postoperatively
    Title
    Change from baseline Bone mineral density by DEXA at 12 months
    Description
    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).
    Time Frame
    Measurements will be performed 12 months postoperatively
    Title
    Change from baseline Bone mineral density by DEXA at 24 months
    Description
    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).
    Time Frame
    Measurements will be performed 24 months postoperatively
    Secondary Outcome Measure Information:
    Title
    Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months
    Description
    Assessment of radiographs for radiolucent lines (RLs) around the stem.
    Time Frame
    Measurements will be performed at 12 months postoperatively.
    Title
    Rate of radiolucent lines on hip radiographs (AP and axial) at 24 months
    Description
    Assessment of radiographs for radiolucent lines (RLs) around the stem.
    Time Frame
    Measurements will be performed at 24 months postoperatively.
    Title
    Rate of osteolysis on hip radiographs (AP and axial) at 12 months
    Description
    Assessment of radiographs for osteolysis around the stem.
    Time Frame
    Measurements will be performed at 12 months postoperatively.
    Title
    Rate of osteolysis on hip radiographs (AP and axial) at 24 months
    Description
    Assessment of radiographs for osteolysis around the stem.
    Time Frame
    Measurements will be performed at 24 months postoperatively.
    Title
    Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 12 months
    Description
    Assessment of radiographs for hypertrophies and atrophies around the stem.
    Time Frame
    Measurements will be performed at 12 months postoperatively.
    Title
    Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 24 months.
    Description
    Assessment of radiographs for hypertrophies and atrophies around the stem.
    Time Frame
    Measurements will be performed at 24 months postoperatively.
    Title
    Baseline WOMAC
    Description
    For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
    Time Frame
    Measurements will be performed 1 month preoperatively.
    Title
    Change in WOMAC at 12 months
    Description
    For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
    Time Frame
    Measurements will be performed 12 months postoperatively
    Title
    Change in WOMAC at 24 months
    Description
    For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
    Time Frame
    Measurements will be performed 24 months postoperatively
    Title
    Baseline HHS
    Description
    For clinical scoring, the Harris Hip Score (HHS) will be assessed.
    Time Frame
    Measurements will be performed 1 month preoperatively.
    Title
    Change in HHS at 12 months
    Description
    For clinical scoring, the Harris Hip Score (HHS) will be assessed.
    Time Frame
    Measurements will be performed 12 months postoperatively
    Title
    Change in HHS at 24 months
    Description
    For clinical scoring, the Harris Hip Score (HHS) will be assessed.
    Time Frame
    Measurements will be performed 24 months postoperatively
    Title
    Survival rates
    Description
    THA survival rates and adverse events will be documented up to 24 months postoperatively.
    Time Frame
    Up to 24 months postoperatively.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Niklaus F. Friederich, MD, Prof.
    Organizational Affiliation
    Kantonsspital Baselland Bruderholz
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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