Bone Remodeling Around HA-coated Acetabular Cups.

Study Overview
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Brief Summary
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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
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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

Official Title
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Bone Remodeling Around HA-coated Acetabular Cups.

Conditions
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Coxarthrosis

Intervention / Treatment
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* Device: porous coated Trilogy®
* Device: Trilogy Calcicoat®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients eligible for cementless THA Exclusion Criteria: Medical conditions interfering with bone metabolism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard porouscoated Trilogy Cup | Device: porous coated Trilogy®<br>* THA<br>* Other names: Zimmer;|
| Experimental: 2<br>HA coated Trilogy cup | Device: Trilogy Calcicoat®<br>* THA<br>* Other names: Zimmer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning |  | 8-12 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hip performance, measured by Harris Hip Score |  | 8-12 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THA