Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty

N/AUnknownNCT01319227

Danderyd Hospital51 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis

Interventions

Hip replacementPROCEDURE

Hip arthroplasty with uncemented components

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

Orthopaedic Department, Danderyd Hospital

Stockholm, Stockholm County, Sweden

Outcomes

Primary Outcomes

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

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.

Data from ClinicalTrials.gov

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