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

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: Completed
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Device: SL-PLUS-Stem for total hip arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	Measurements will be performed 24 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months	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	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	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	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	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.	Assessment of radiographs for hypertrophies and atrophies around the stem.	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.	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.	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.	Measurements will be performed 24 months postoperatively
Baseline HHS	For clinical scoring, the Harris Hip Score (HHS) will be assessed.	Measurements will be performed 1 month preoperatively.
Change in HHS at 12 months	For clinical scoring, the Harris Hip Score (HHS) will be assessed.	Measurements will be performed 12 months postoperatively
Change in HHS at 24 months	For clinical scoring, the Harris Hip Score (HHS) will be assessed.	Measurements will be performed 24 months postoperatively
Survival rates	THA survival rates and adverse events will be documented up to 24 months postoperatively.	Up to 24 months postoperatively.

Collaborators and Investigators

• Sponsor: Kantonsspital Baselland Bruderholz
• Collaborators: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Niklaus F. Friederich, MD, Prof., Kantonsspital Baselland Bruderholz

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2006
• Primary Completion (Actual): September 30, 2008
• Study Completion (Actual): May 31, 2012

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID 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