Bone Remodeling Around HA-coated Acetabular Cups.

Phase 4

Completed

• Conditions: Coxarthrosis
• Interventions: Device: porous coated Trilogy®; Device: Trilogy Calcicoat®

• Registration Number: NCT00159497
• Lead Sponsor: Northern Orthopaedic Division, Denmark

Brief 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

Detailed 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

Study Timeline

• Study Start: 1998-10
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-28
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients eligible for cementless THA

Exclusion Criteria

• Medical conditions interfering with bone metabolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	porous coated Trilogy®	Standard porouscoated Trilogy Cup
2	Trilogy Calcicoat®	HA coated Trilogy cup

Primary Outcome Measures

Name	Time	Method
Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning	8-12 years

Secondary Outcome Measures

Name	Time	Method
Changes in hip performance, measured by Harris Hip Score	8-12 years

Trial Locations

Locations (1)

Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital; 🇩🇰 Farsoe, Northern Jutland, Denmark