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

NCT05053048 | Completed

• 1 other identifier: 20052021
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (13)

• Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months

  Measurements will be performed at 12 months postoperatively.

• Rate of radiolucent lines on hip radiographs (AP and axial) at 24 months

  Measurements will be performed at 24 months postoperatively.

• Rate of osteolysis on hip radiographs (AP and axial) at 12 months

  Measurements will be performed at 12 months postoperatively.

• Rate of osteolysis on hip radiographs (AP and axial) at 24 months

  Measurements will be performed at 24 months postoperatively.

• Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 12 months

  Measurements will be performed at 12 months postoperatively.

Study Arms (2)

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.

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.

Device: SL-PLUS-Stem for total hip arthroplasty

Interventions

SL-PLUS-Stem for total hip arthroplasty DEVICE

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.

NT-SL-PLUS Stem; STD-SL-PLUS stem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Kantonsspital Baselland Bruderholz: lead
• Smith & Nephew, Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 38430413 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Niklaus F. Friederich, MD, Prof.

  Kantonsspital Baselland Bruderholz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Prof.

Model Details: Randomised controlles trial, double-blind. Block randomization with block size 10.

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 22, 2021
• Study Start: August 1, 2006
• Primary Completion: September 30, 2008
• Study Completion: May 31, 2012
• Last Updated: September 22, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share