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NCT00159497 Clinical Trial

Bone Remodeling Around HA-coated Acetabular Cups.

Coxarthrosis Clinical Trial

Official title:
Bone Remodeling Around HA-coated Acetabular Cups.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00159497
Other study ID # ON-04-001-MBL
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated March 28, 2014
Start date October 1998
Est. completion date January 2011

Study information
Verified date March 2014
Source Northern Orthopaedic Division, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

This study was designed to investigate the influence of HA-coating on bone remodeling around the cup in cementless THA.

100 patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation. The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral Density (BMD) determined by DEXA scanning.

Measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above normal regained more bone mineral than patients with normal weight. This finding supports the assumption that load is beneficial to bone remodeling. Advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations

Description:

This study was designed to investigate the influence of HA-coating on bone remodeling around the cup in cementless THA.

100 patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation. The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral Density (BMD) determined by DEXA scanning.

Measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above normal regained more bone mineral than patients with normal weight. This finding supports the assumption that load is beneficial to bone remodeling. Advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients eligible for cementless THA

Exclusion Criteria:

- Medical conditions interfering with bone metabolism

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• porous coated Trilogy®
THA
• Trilogy Calcicoat®
THA

Locations
Country Name City State
Denmark Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital Farsoe Northern Jutland

Sponsors (1)
Lead Sponsor Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning 8-12 years No
Secondary Changes in hip performance, measured by Harris Hip Score 8-12 years No
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