Bone Remodeling Around HA-coated Acetabular Cups.
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 1998
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1998
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMarch 31, 2014
March 1, 2014
12.3 years
September 9, 2005
March 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning
8-12 years
Secondary Outcomes (1)
Changes in hip performance, measured by Harris Hip Score
8-12 years
Study Arms (2)
1
ACTIVE COMPARATORStandard porouscoated Trilogy Cup
2
EXPERIMENTALHA coated Trilogy cup
Interventions
Eligibility Criteria
You may qualify if:
- Patients eligible for cementless THA
You may not qualify if:
- Medical conditions interfering with bone metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital
Farsø, Northern Jutland, Denmark
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mogens B Laursen, MD
Northern Orthopaedic Division
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 12, 2005
Study Start
October 1, 1998
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
March 31, 2014
Record last verified: 2014-03