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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01319227
Recruitment Status : Active, not recruiting
First Posted : March 21, 2011
Last Update Posted : August 30, 2016
Sponsor:
Collaborator:
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Information provided by (Responsible Party):
Olof Skoldenberg, Danderyd Hospital

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. 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Hip replacement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Periprosthetic Bone Remodeling Around Two Different Types of Uncemented Femoral Stems and Two Uncemented Acetabular Components in Total Hip Arthroplasty
Study Start Date : October 2009
Actual Primary Completion Date : August 2013
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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. ]
  2. 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 ]

Secondary Outcome Measures :
  1. Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis (RSA) [ Time Frame: at 2 years ]
  2. 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 ]
  3. 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 ]
  4. 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. ]

Other Outcome Measures:
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319227


Locations
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Sweden
Orthopaedic Department, Danderyd Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Danderyd Hospital
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
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Responsible Party: Olof Skoldenberg, Consultant Orthopaedic Surgeon, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01319227    
Other Study ID Numbers: PeriBRUSBRAC
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Keywords provided by Olof Skoldenberg, Danderyd Hospital:
Periprosthetic bone remodeling
Stress shielding
Short femoral stem
Porous Titanium Construct
Polyethylene wear
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases