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Bone Remodeling Around HA-coated Acetabular Cups.

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ClinicalTrials.gov Identifier: NCT00159497
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 31, 2014
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

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
Coxarthrosis 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 Type : Interventional  (Clinical Trial)
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 : October 1998
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning [ Time Frame: 8-12 years ]

Secondary Outcome Measures :
  1. Changes in hip performance, measured by Harris Hip Score [ Time Frame: 8-12 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients eligible for cementless THA

Exclusion Criteria:

  • Medical conditions interfering with bone metabolism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159497


Locations
Denmark
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

Additional Information:
Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00159497     History of Changes
Other Study ID Numbers: ON-04-001-MBL
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014

Keywords provided by Northern Orthopaedic Division, Denmark:
THA

Additional relevant MeSH terms:
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases