Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty (PeriBRUSBRAC)

August 29, 2016 updated by: Olof Skoldenberg, Danderyd Hospital

Periprosthetic Bone Remodeling Around Two Different Types of Uncemented Femoral Stems and Two Uncemented Acetabular Components in Total Hip Arthroplasty

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. A short uncemented stem gives less periprosthetic bone resorption in the proximal femur than a conventional uncemented stem.
  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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Consecutive patients 40-70 years old who are being planned for Total Hip Arthroplasty (THA) will be eligible for inclusion in the study.

Periprosthetic bone remodeling, migration of the components and clinical scores will be recorded prospectively.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 18288
        • Orthopaedic department, Danderyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hip Arthroplasty, ultra-short stem, conventional cup
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 with uncemented components
Other Names:
  • 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.
Experimental: Hip Arthroplasty, conventional stem, trabecular-titanium cup
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
Hip arthroplasty with uncemented components
Other Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA)
Time Frame: bone mineral density (BMD) measured postoperatively at 2 years.
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)
Time Frame: bone mineral density (BMD) measured postoperatively at 2 years
bone mineral density (BMD) measured postoperatively at 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis (RSA)
Time Frame: at 2 years
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)
Time Frame: at 2 years
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)
Time Frame: at 6 and 10 years
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)
Time Frame: at 6 and 10 years.
at 6 and 10 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome measures with validated scores comparing patients receiving different stems and acetabular components
Time Frame: Self administred validated score outcome measures after 6 weeks, after 3, 6, 12, 24 months and after 6 and 10 years
Validated scores included are Harris Hip Score (HHS), Euroqol 5-dimension (Eq5d) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Self administred validated score outcome measures after 6 weeks, after 3, 6, 12, 24 months and after 6 and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danderyd Hospital

Collaborators

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

March 18, 2011

First Posted (Estimate)

March 21, 2011

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PeriBRUSBRAC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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