Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty

Osteoarthritis Clinical Trial

— PeriBRUSBRAC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01319227
• Other study ID #: PeriBRUSBRAC
• Status: Active, not recruiting
• Phase: N/A
• First received: March 18, 2011
• Last updated: August 29, 2016
• Start date: October 2009
• Est. completion date: August 2023

Study information

• Verified date: August 2016
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: August 2023
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Hip replacement
Hip arthroplasty with uncemented components

Locations

Country	Name	City	State
Sweden	Orthopaedic Department, Danderyd Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical outcome measures with validated scores comparing patients receiving different stems and acetabular components	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	No
Primary	Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA)		bone mineral density (BMD) measured postoperatively at 2 years.	No
Primary	Bone remodelling, i e change in bone mineral density behind the acetabular component, as measured with dual energy x-ray absorptiometry (DEXA)		bone mineral density (BMD) measured postoperatively at 2 years	No
Secondary	Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis (RSA)		at 2 years	No
Secondary	Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA)		at 2 years	No
Secondary	Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA)		at 6 and 10 years	No
Secondary	Bone remodelling, i e change in bone mineral density around the stem and cup, as measured with dual energy x-ray absorptiometry (DEXA)		at 6 and 10 years.	No