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Completed

NCT Number: NCT00159497

Bone Remodeling Around HA-coated Acetabular Cups.

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

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Key information

Conditions

Coxarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients eligible for cementless THA

Exclusion criteria

  • Medical conditions interfering with bone metabolism

Treatment and study plan

porous coated Trilogy®

Device

THA

Other names: Zimmer

Trilogy Calcicoat®

Device

THA

Other names: Zimmer

Primary outcomes

  1. Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning

    Time frame: 8-12 years

Secondary outcomes

  1. Changes in hip performance, measured by Harris Hip Score

    Time frame: 8-12 years

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Important dates

Study start
1998
Primary completion
2011
Study completion
2011
First posted
Sep 12, 2005
Registry last updated
Mar 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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