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Preheating of Femur Component in Hybrid Total Hip Arthroplasty

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Total hip replacement (Preheating of femur stem)
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Arthroplasty,, Hip,, Pre-heating,, Radiostereometric analysis,, Dual-Energy Radiographic Absorptiometry,

Eligibility Criteria

70 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patients suffering of hip osteoarthritis Exclusion Criteria: The patients with ASA score >II The patients with cancer The secondary coxarthrosis after the trauma Any vascular or neuromuscular diseases affecting the hip.

Sites / Locations

  • Farsoe Hospital, Northern Orthopaedic Division

Outcomes

Primary Outcome Measures

Stem migration in mm

Secondary Outcome Measures

Bone mineral density g/cm2
Temperature at bone-cement interface, degrees in Celsius
Serum- Titanium measurements in blood samples

Full Information

First Posted
April 27, 2006
Last Updated
April 9, 2015
Sponsor
Northern Orthopaedic Division, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00319085
Brief Title
Preheating of Femur Component in Hybrid Total Hip Arthroplasty
Official Title
Comparison Between Preheated and Non-preheated Femur Component in Hybrid Total Hip Arthroplasty (THA) A Prospective Randomized Study of the 80 THA Using Radiostereometry.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background Recently published studies confirm that preheating of femoral component enhances shear strength of implant-cement interface. Both Iesaka et al 2003 and Jafri et al 2004 showed reduction in cement porosity on cement-implant interface with preheated femur components. We will use the radiostereometry analysis (RSA) to investigate how the preheating of femur component influence on prosthesis survivorship. There are no clinical controlled studies performed to the date. The aim of the study Comparison of the migration rates between preheated and non-preheated femur components, analyzed with RSA. Methods Randomization of 80 patients into 2 groups with 40 in each. All patients will undergo standard hybrid total hip replacement. In group one the femur component (Bi-Metric, Interlock Biomet) will be preheated to 40 degrees of Celsius before cementation. In group two: the control group, the femur component will be of room temperature. We will measure the temperature at cement bone interface during the operation with use of thermocouple electrodes inserted through separate drill hole in the femur. The measurements will be recorded every 10 seconds. The patients will follow the standard postoperative rehabilitation program. The RSA analysis will be performed the first day after the operation and at 3, 12, 24 months postoperatively. The Dual-energy X-ray absorptiometry scanning (DEXA) of the femur will be performed at the first week after the operation and at 12 and 24 months postoperatively. The patients will be followed both clinically and radiologically at 1 and 2 years after the operation (Harris Hip Score). The results will be expressed as mean + SD (in mm). ANOVA statistical analysis will be used to confirm the differences between the groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
Arthroplasty,, Hip,, Pre-heating,, Radiostereometric analysis,, Dual-Energy Radiographic Absorptiometry,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Total hip replacement (Preheating of femur stem)
Intervention Description
Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA
Primary Outcome Measure Information:
Title
Stem migration in mm
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Bone mineral density g/cm2
Time Frame
2 years
Title
Temperature at bone-cement interface, degrees in Celsius
Time Frame
peroperatively
Title
Serum- Titanium measurements in blood samples
Time Frame
Not defined

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients suffering of hip osteoarthritis Exclusion Criteria: The patients with ASA score >II The patients with cancer The secondary coxarthrosis after the trauma Any vascular or neuromuscular diseases affecting the hip.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mogens B Jørgensen, M.D.
Organizational Affiliation
Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mogens B Laursen, M.D., Ph.D
Organizational Affiliation
Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lotte Borgwardt, dr.
Organizational Affiliation
Frederikberg Hospital, Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kjeld Søballe, Ph.D., MD.
Organizational Affiliation
University Hospital of Aarhus
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Poul T Nielsen, M.D.
Organizational Affiliation
Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Farsoe Hospital, Northern Orthopaedic Division
City
Farsoe
ZIP/Postal Code
9640
Country
Denmark

12. IPD Sharing Statement

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Preheating of Femur Component in Hybrid Total Hip Arthroplasty

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