Osteoarthritis
Conditions
Keywords
Periprosthetic bone remodeling, Stress shielding, Short femoral stem, Porous Titanium Construct, Polyethylene wear
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: 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.
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.
Interventions
PROCEDUREHip replacement
Hip arthroplasty with uncemented components
Sponsors
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Danderyd Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 2 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome measures with validated scores comparing patients receiving different stems and acetabular components | Self administred validated score outcome measures after 6 weeks, after 3, 6, 12, 24 months and after 6 and 10 years | Validated scores included are Harris Hip Score (HHS), Euroqol 5-dimension (Eq5d) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
Countries
Sweden
Outcome results
None listed