Periprosthetic Bone Remodeling Around Two Different Types of Uncemented Femoral Stems and Two Uncemented Acetabular Components in Total Hip Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA)
Study Overview
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:
- A short uncemented stem gives less periprosthetic bone resorption in the proximal femur than a conventional uncemented stem.
- 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 40-70 years old
- •Primary osteoarthritis of the hip
- •Type A or B femur according to Dorr10
- •Femoral anatomy allowing implantation of both femoral stems
- •Willingness and ability to follow study-protocol -
Exclusion Criteria
- •Inflammatory arthritis
- •Abnormal femoral anatomy after hip dysplasia, not suitable for implantation of components
- •Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery
- •Ongoing oestrogen treatment
- •Type C femur according to Dorr
- •Not suited for the study for other reason (surgeons preference)
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)(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)(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)(at 6 and 10 years.)
Investigators
Olof Skoldenberg
Consultant Orthopaedic Surgeon
Danderyd Hospital