Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty

Not Applicable

• Conditions: Osteoarthritis

• Registration Number: NCT01319227
• Lead Sponsor: Danderyd Hospital

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Primary Completion: 2013-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Orthopaedic Department, Danderyd Hospital; 🇸🇪 Stockholm, Sweden