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Bone Remodeling Around HA-coated Acetabular Cups.

Primary Purpose

Coxarthrosis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
porous coated Trilogy®
Trilogy Calcicoat®
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coxarthrosis focused on measuring THA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients eligible for cementless THA Exclusion Criteria: Medical conditions interfering with bone metabolism

Sites / Locations

  • Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Standard porouscoated Trilogy Cup

HA coated Trilogy cup

Outcomes

Primary Outcome Measures

Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning

Secondary Outcome Measures

Changes in hip performance, measured by Harris Hip Score

Full Information

First Posted
September 9, 2005
Last Updated
March 28, 2014
Sponsor
Northern Orthopaedic Division, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00159497
Brief Title
Bone Remodeling Around HA-coated Acetabular Cups.
Official Title
Bone Remodeling Around HA-coated Acetabular Cups.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis
Keywords
THA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard porouscoated Trilogy Cup
Arm Title
2
Arm Type
Experimental
Arm Description
HA coated Trilogy cup
Intervention Type
Device
Intervention Name(s)
porous coated Trilogy®
Other Intervention Name(s)
Zimmer
Intervention Description
THA
Intervention Type
Device
Intervention Name(s)
Trilogy Calcicoat®
Other Intervention Name(s)
Zimmer
Intervention Description
THA
Primary Outcome Measure Information:
Title
Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning
Time Frame
8-12 years
Secondary Outcome Measure Information:
Title
Changes in hip performance, measured by Harris Hip Score
Time Frame
8-12 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients eligible for cementless THA Exclusion Criteria: Medical conditions interfering with bone metabolism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mogens B Laursen, MD
Organizational Affiliation
Northern Orthopaedic Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital
City
Farsoe
State/Province
Northern Jutland
Country
Denmark

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Citation&list_uids=16761153
Description
The final paper from this trial.

Learn more about this trial

Bone Remodeling Around HA-coated Acetabular Cups.

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