Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment hip replacement
Sponsor Danderyd Hospital
Collaborator Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Start date October 2009
End date August 2013
Trial size 51 participants
Trial identifier NCT01319227, PeriBRUSBRAC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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
hip replacement Ultra-short hydroxyapatite-coated Proxima stem and hydroxyapatite covered porous coated Pinnacle cup from DePuy, Johnson&Johnson.
Hip arthroplasty with uncemented components
(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
hip replacement Ultra-short hydroxyapatite-coated Proxima stem and hydroxyapatite covered porous coated Pinnacle cup from DePuy, Johnson&Johnson.
Hip arthroplasty with uncemented components

Primary Outcomes

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.
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 Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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)

Additional Information

Official title Periprosthetic Bone Remodeling Around Two Different Types of Uncemented Femoral Stems and Two Uncemented Acetabular Components in Total Hip Arthroplasty
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Danderyd Hospital.