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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Danderyd Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings