Preheating of Femur Component in Hybrid Total Hip Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00319085
First received: April 27, 2006
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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

  • We will randomize 80 patients into 2 groups with 40 in each. All the 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- also 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 radiological 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.

Condition Intervention Phase
Osteoarthritis, Hip
Procedure: Total hip replacement (Preheating of femur stem)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Stem migration in mm [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone mineral density g/cm2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Temperature at bone-cement interface, degrees in Celsius [ Time Frame: peroperatively ] [ Designated as safety issue: No ]
  • Serum- Titanium measurements in blood samples [ Time Frame: Not defined ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: May 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Total hip replacement (Preheating of femur stem)
    Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA
  Eligibility

Ages Eligible for Study:   70 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319085

Locations
Denmark
Farsoe Hospital, Northern Orthopaedic Division
Farsoe, Denmark, 9640
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
Principal Investigator: Mogens B Jørgensen, M.D. Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Principal Investigator: Mogens B Laursen, M.D., Ph.D Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Principal Investigator: Lotte Borgwardt, dr. Frederikberg Hospital, Copenhagen
Study Chair: Kjeld Søballe, Ph.D., MD. University Hospital of Aarhus
Study Director: Poul T Nielsen, M.D. Northern Orthopaedic Division, Aalborg University Hospital, Denmark
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00319085     History of Changes
Other Study ID Numbers: ON-04-008a-JPE
Study First Received: April 27, 2006
Last Updated: September 12, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Arthroplasty,
Hip,
Pre-heating,
Radiostereometric analysis,
Dual-Energy Radiographic Absorptiometry,

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

ClinicalTrials.gov processed this record on September 18, 2014