Bone Remodeling Around HA-coated Acetabular Cups.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00159497
First received: September 9, 2005
Last updated: March 28, 2014
Last verified: March 2014
  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.

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning [ Time Frame: 8-12 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Patients eligible for cementless THA

Exclusion Criteria:

  • Medical conditions interfering with bone metabolism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: March 28, 2014
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 April 21, 2014