Bone Remodeling Around HA-coated Acetabular Cups.
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Bone Remodeling Around HA-coated Acetabular Cups. |
- Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning [ Time Frame: 8-12 years ] [ Designated as safety issue: No ]
- Changes in hip performance, measured by Harris Hip Score [ Time Frame: 8-12 years ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | October 1998 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Standard porouscoated Trilogy Cup
|
Device: porous coated Trilogy®
THA
Other Name: Zimmer
|
|
Experimental: 2
HA coated Trilogy cup
|
Device: Trilogy Calcicoat®
THA
Other Name: Zimmer
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients eligible for cementless THA
Exclusion Criteria:
- Medical conditions interfering with bone metabolism
Contacts and Locations| Denmark | |
| Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital | |
| Farsoe, Northern Jutland, Denmark | |
| Principal Investigator: | Mogens B Laursen, MD | Northern Orthopaedic Division |
More Information
Additional Information:
No publications provided
| Responsible Party: | Northern Orthopaedic Division, Denmark |
| ClinicalTrials.gov Identifier: | NCT00159497 History of Changes |
| Other Study ID Numbers: | ON-04-001-MBL |
| Study First Received: | September 9, 2005 |
| Last Updated: | May 1, 2013 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: The Danish Dataprotection Agency |
Keywords provided by Northern Orthopaedic Division, Denmark:
|
THA |
Additional relevant MeSH terms:
|
Osteoarthritis, Hip Osteoarthritis Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013