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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Olof Skoldenberg, Danderyd Hospital

ClinicalTrials.gov Identifier:

NCT01319227

First received: March 18, 2011

Last updated: October 2, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 18, 2011
Last Updated Date	October 2, 2012
Start Date ^ICMJE	October 2009
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 2, 2012)	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 and after 3, 6, 12, 24 months and after 6 and 10 years ] [ Designated as safety issue: No ] 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 and after 3, 6, 12, 24 months and after 6 and 10 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 18, 2011)	Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame: BMD measured postoperatively and after 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01319227 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 2, 2012)	Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis (RSA) [ Time Frame: RSA measured postoperatively, after 6 weeks, after 3, 6, 12, 24 months and after 6 and 10 years ] [ Designated as safety issue: No ] 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: RSA measured postoperatively, after 6 weeks, after 3, 6, 12, 24 months and after 6 and 10 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 18, 2011)	Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis (RSA) [ Time Frame: RSA measured postoperatively after 6 weeks and after 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE (submitted: October 2, 2012)	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 ] [ Designated as safety issue: No ] Validated scores included are Harris Hip Score (HHS), Euroqol 5-dimension (Eq5d) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty
Official Title ^ICMJE	Periprosthetic Bone Remodeling Around Two Different Types of Uncemented Femoral Stems and Two Uncemented Acetabular Components in Total Hip Arthroplasty
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: 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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Osteoarthritis
Intervention ^ICMJE	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.
Study Arm (s)	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 Intervention: Procedure: Hip replacement 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 Intervention: Procedure: Hip replacement
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	51
Estimated Completion Date	December 2021
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 - Exclusion Criteria: 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)
Gender	Both
Ages	40 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01319227
Other Study ID Numbers ^ICMJE	PeriBRUSBRAC
Has Data Monitoring Committee	No
Responsible Party	Olof Skoldenberg, Danderyd Hospital
Study Sponsor ^ICMJE	Danderyd Hospital
Collaborators ^ICMJE	Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Danderyd Hospital
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top