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| Sponsored by: |
Northern Orthopaedic Division, Denmark |
|---|---|
| Information provided by: | Northern Orthopaedic Division, Denmark |
| ClinicalTrials.gov Identifier: | NCT00159497 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Coxarthrosis |
Device: porous coated Trilogy® Device: Trilogy Calcicoat® |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Bone Remodeling Around HA-Coated Acetabular Cups. |
| Enrollment: | 100 |
| Study Start Date: | October 1998 |
| Estimated Study Completion Date: | July 2012 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Standard porouscoated Trilogy Cup
|
Device: porous coated Trilogy®
THA
|
|
2: Experimental
HA coated Trilogy cup
|
Device: Trilogy Calcicoat®
THA
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark, Northern Jutland | |
| Northern Orthopaedic Division, Klinik Farsoe | |
| Farsoe, Northern Jutland, Denmark | |
| Principal Investigator: | Mogens B Laursen, MD | Northern Orthopaedic Division |
More Information
| Study ID Numbers: | ON-04-001-MBL |
| Study First Received: | September 9, 2005 |
| Last Updated: | October 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00159497 History of Changes |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
|
THA |
|
Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Rheumatic Diseases Osteoarthritis, Hip |
|
Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Rheumatic Diseases Osteoarthritis, Hip |
