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Bone Remodeling Around HA-coated Acetabular Cups.

Sponsor
Northern Orthopaedic Division, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT00159497
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
147
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: porous coated Trilogy®
  • Device: Trilogy Calcicoat®
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Bone Remodeling Around HA-coated Acetabular Cups.
Study Start Date :
Oct 1, 1998
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Standard porouscoated Trilogy Cup

Device: porous coated Trilogy®
THA
Other Names:
  • Zimmer

    		•
    Experimental: 2

    HA coated Trilogy cup

    Device: Trilogy Calcicoat®
    THA
    Other Names:
  • Zimmer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning [8-12 years]

    Secondary Outcome Measures

    1. Changes in hip performance, measured by Harris Hip Score [8-12 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients eligible for cementless THA
    Exclusion Criteria:
    • Medical conditions interfering with bone metabolism

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital Farsoe Northern Jutland Denmark

    Sponsors and Collaborators

    • Northern Orthopaedic Division, Denmark

    Investigators

    • Principal Investigator: Mogens B Laursen, MD, Northern Orthopaedic Division

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Northern Orthopaedic Division, Denmark
    ClinicalTrials.gov Identifier:
    NCT00159497
    Other Study ID Numbers:
    • ON-04-001-MBL
    First Posted:
    Sep 12, 2005
    Last Update Posted:
    Mar 31, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Northern Orthopaedic Division, Denmark
    THA
    Additional relevant MeSH terms:
    Osteoarthritis, Hip

    Study Results

    No Results Posted as of Mar 31, 2014