Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty

NCT01319227 | Unknown

• 1 other identifier: PeriBRUSBRAC
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized clinical trial comparing two different uncemented femoral stems and two different uncemented sockets using Dual-energy x-ray absorptiometry, Radiostereometry and clinical evaluation. Hypothesis:

1. 1.A short uncemented stem gives less periprosthetic bone resorption in the proximal femur than a conventional uncemented stem.
2. 2.An uncemented acetabular component with a backside of three-dimensional Titanium porous construct gives less periprosthetic bone resorption than a backside covered with a conventional porous coating with Titanium-beads and a hydroxy-apatite layer.

Conditions

Osteoarthritis

Keywords

Periprosthetic bone remodeling; Stress shielding; Short femoral stem; Porous Titanium Construct; Polyethylene wear

Outcome Measures

Primary Outcomes (2)

• Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA)

  bone mineral density (BMD) measured postoperatively at 2 years.

• Bone remodelling, i e change in bone mineral density behind the acetabular component, as measured with dual energy x-ray absorptiometry (DEXA)

  bone mineral density (BMD) measured postoperatively at 2 years

Secondary Outcomes (4)

• Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis (RSA)

  at 2 years

• Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA)

  at 2 years

• Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA)

  at 6 and 10 years

• Bone remodelling, i e change in bone mineral density around the stem and cup, as measured with dual energy x-ray absorptiometry (DEXA)

  at 6 and 10 years.

Other Outcomes (1)

• Clinical outcome measures with validated scores comparing patients receiving different stems and acetabular components

  Self administred validated score outcome measures after 6 weeks, after 3, 6, 12, 24 months and after 6 and 10 years

Study Arms (2)

Hip Arthroplasty, ultra-short stem, conventional cup

EXPERIMENTAL

Hip replacement with a hydroxy-apatite covered ultra-short uncemented femoral stem and a conventional uncemented acetabular cup with hydroxy-apatite covered porous coating and a moderately cross-linked polyethylene cup liner

Procedure: Hip replacement

Hip Arthroplasty, conventional stem, trabecular-titanium cup

EXPERIMENTAL

Hip replacement with an uncemented tapered femoral stem and an uncemented acetabular cup with trabecular-Titanium backside and E-vitamin-treated polyethylene cup liner

Procedure: Hip replacement

Interventions

Hip replacement PROCEDURE

Hip arthroplasty with uncemented components

Also known as: Ultra-short hydroxyapatite-coated Proxima stem and hydroxyapatite covered porous coated Pinnacle cup from DePuy, Johnson&Johnson., Tapered, proximally porous and hydroxyapatite-coated, Bimetric stem and a Regenerex cup with trabecular-Titanium-backside from Biomet.

Hip Arthroplasty, conventional stem, trabecular-titanium cup; Hip Arthroplasty, ultra-short stem, conventional cup

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-70 years old
• Primary osteoarthritis of the hip
• Type A or B femur according to Dorr10
• Femoral anatomy allowing implantation of both femoral stems
• Willingness and ability to follow study-protocol -

You may not qualify if:

• Inflammatory arthritis
• Abnormal femoral anatomy after hip dysplasia, not suitable for implantation of components
• Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery
• Ongoing oestrogen treatment
• Type C femur according to Dorr
• Not suited for the study for other reason (surgeons preference)

Sponsors & Collaborators

• Danderyd Hospital: lead
• Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.: collaborator

Study Sites (1)

Orthopaedic Department, Danderyd Hospital

Stockholm, Stockholm County, 18288, Sweden

Location

Related Publications (1)

• Axenhus M, Salemyr M, Mukka S, Magneli M, Skoldenberg O. Long-term evaluation of periprosthetic bone changes in ultra-short versus conventional stems in total hip arthroplasty: a 10-year follow-up of a randomised controlled trial. Hip Int. 2025 Dec 18:11207000251371283. doi: 10.1177/11207000251371283. Online ahead of print.

  PMID: 41410176 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Orthopaedic Surgeon

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 21, 2011
• Study Start: October 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2023
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

SE (1)