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

Hip Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05053048
• Other study ID #: 20052021
• Status: Completed
• Phase: N/A
• Start date: August 1, 2006
• Est. completion date: May 31, 2012

Study information

• Verified date: August 2021
• Source: Kantonsspital Baselland Bruderholz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 31, 2012
• Est. primary completion date: September 30, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Baselland Bruderholz	Smith & Nephew, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Baseline WOMAC	For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.	Measurements will be performed 1 month preoperatively.
Secondary	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
Secondary	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
Secondary	Baseline HHS	For clinical scoring, the Harris Hip Score (HHS) will be assessed.	Measurements will be performed 1 month preoperatively.
Secondary	Change in HHS at 12 months	For clinical scoring, the Harris Hip Score (HHS) will be assessed.	Measurements will be performed 12 months postoperatively
Secondary	Change in HHS at 24 months	For clinical scoring, the Harris Hip Score (HHS) will be assessed.	Measurements will be performed 24 months postoperatively
Secondary	Survival rates	THA survival rates and adverse events will be documented up to 24 months postoperatively.	Up to 24 months postoperatively.