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Bone Remodeling Around HA-coated Acetabular Cups.

Bone Remodeling Around HA-coated Acetabular Cups.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00159497
Enrollment
100
Registered
2005-09-12
Start date
1998-10-31
Completion date
2011-01-31
Last updated
2014-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coxarthrosis

Keywords

THA

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

Interventions

DEVICEporous coated Trilogy®

THA

DEVICETrilogy Calcicoat®

THA

Sponsors

Northern Orthopaedic Division, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients eligible for cementless THA

Exclusion criteria

* Medical conditions interfering with bone metabolism

Design outcomes

Primary

MeasureTime frame
Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning8-12 years

Secondary

MeasureTime frame
Changes in hip performance, measured by Harris Hip Score8-12 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026