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

Danderyd Hospital

Status: Unknown

Conditions: Osteoarthritis

Treatments: Procedure: Hip replacement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01319227

PeriBRUSBRAC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Hip Arthroplasty, ultra-short stem, conventional cup

Experimental group

Description:

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

Treatment:

Procedure: Hip replacement

Hip Arthroplasty, conventional stem, trabecular-titanium cup

Experimental group

Description:

Hip replacement with an uncemented tapered femoral stem and an uncemented acetabular cup with trabecular-Titanium backside and E-vitamin-treated polyethylene cup liner

Treatment:

Procedure: Hip replacement