Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159497
Status:
COMPLETED
Last Update Posted:
2014-03-31
First Post:
2005-09-09
Brief Title:
Bone Remodeling Around HA-coated Acetabular Cups
Sponsor:
Northern Orthopaedic Division Denmark
Organization:
Northern Orthopaedic Division Denmark
Study Overview
Official Title:
Bone Remodeling Around HA-coated Acetabular Cups
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None