Clinical trial NCT01319227: Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty
Official title: Periprosthetic Bone Remodeling Around Two Different Types of Uncemented Femoral Stems and Two Uncemented Acetabular Components in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: Periprosthetic bone remodeling
Stress shielding
Short femoral stem
Porous Titanium Construct
Polyethylene wear
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
First posted: 2011-03-21
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA)
timeFrame: bone mineral density (BMD) measured postoperatively at 2 years.
measure: Bone remodelling, i e change in bone mineral density behind the acetabular component, as measured with dual energy x-ray absorptiometry (DEXA)
timeFrame: 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)
timeFrame: at 2 years
measure: Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA)
timeFrame: at 2 years
measure: Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA)
timeFrame: at 6 and 10 years
measure: Bone remodelling, i e change in bone mineral density around the stem and cup, as measured with dual energy x-ray absorptiometry (DEXA)
timeFrame: at 6 and 10 years.
Other outcomes:
measure: Clinical outcome measures with validated scores comparing patients receiving different stems and acetabular components
timeFrame: Self administred validated score outcome measures after 6 weeks, after 3, 6, 12, 24 months and after 6 and 10 years
Locations:
city: Stockholm
country: Sweden
facility: Orthopaedic Department, Danderyd Hospital
Study officials:
References: