OsteoarthritisPeriBRUSBRACNCT01319227
Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty
A study testing Hip replacement in people with Osteoarthritis, run by Danderyd Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hip replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2009to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Orthopaedic Department, Danderyd Hospital
Stockholm, Stockholm County, 18288
About this study
Official title: 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:
- A short uncemented stem gives less periprosthetic bone resorption in the proximal femur than a conventional uncemented stem.
- 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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Hip replacement
- Keywords
- Periprosthetic bone remodeling, Stress shielding, Short femoral stem, Porous Titanium Construct, Polyethylene wear
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip replacementProcedure or surgery
Also called 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 with uncemented components
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at 6 and 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startOct 2009
- Primary completionAug 2013
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
- Responsible party
- Principal investigator, Olof Skoldenberg, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319227
- Sponsor's protocol ID
- PeriBRUSBRAC
- Acronym
- PeriBRUSBRAC
- Status last verified
- Aug 2016
- First submitted
- 18 Mar 2011
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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. 2026 Jan;36(1):55-63. doi: 10.1177/11207000251371283. Epub 2025 Dec 18.
PubMed 41410176
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periprosthetic Bone Remodeling Around Two Different Types of Uncemented Femoral Stems and Two Uncemented Acetabular Components in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01319227
- Acronym / sponsor ID
- PeriBRUSBRAC / PeriBRUSBRAC
- Conditions
- Osteoarthritis
- Keywords
- Periprosthetic bone remodeling, Stress shielding, Short femoral stem, Porous Titanium Construct, Polyethylene wear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
- Study start
- Oct 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2023 (estimated)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- A short uncemented stem gives less periprosthetic bone resorption in the proximal femur than a conventional uncemented stem.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip Arthroplasty, ultra-short stem, conventional cup | Experimental | Procedure: Hip replacementHip 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 |
| Hip Arthroplasty, conventional stem, trabecular-titanium cup | Experimental | Procedure: Hip replacementHip replacement with an uncemented tapered femoral stem and an uncemented acetabular cup with trabecular-Titanium backside and E-vitamin-treated polyethylene cup liner |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip replacementAlso: 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 with uncemented components | Procedure or surgery | Hip Arthroplasty, conventional stem, trabecular-titanium cup, Hip Arthroplasty, ultra-short stem, conventional cup |
Primary outcome
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 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
4 secondary outcomes
Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis (RSA)
Time frame: 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
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Derived from this study: PubMed 41410176Axenhus 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. 2026 Jan;36(1):55-63. doi: 10.1177/11207000251371283. Epub 2025 Dec 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip replacement in people with Osteoarthritis, run by Danderyd Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01319227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.