Preheating of Femur Component in Hybrid Total Hip Arthroplasty

NCT00319085 | Completed Phase 2 DMC

• 1 other identifier: ON-04-008a-JPE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Hip

Keywords

Arthroplasty,; Hip,; Pre-heating,; Radiostereometric analysis,; Dual-Energy Radiographic Absorptiometry,

Outcome Measures

Primary Outcomes (1)

• Stem migration in mm

  2 years

Secondary Outcomes (3)

• Bone mineral density g/cm2

  2 years

• Temperature at bone-cement interface, degrees in Celsius

  peroperatively

• Serum- Titanium measurements in blood samples

  Not defined

Interventions

Total hip replacement (Preheating of femur stem) PROCEDURE

Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• The patients suffering of hip osteoarthritis

You may not qualify if:

• The patients with ASA score \>II
• The patients with cancer
• The secondary coxarthrosis after the trauma
• Any vascular or neuromuscular diseases affecting the hip.

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead

Study Sites (1)

Farsoe Hospital, Northern Orthopaedic Division

Farsø, 9640, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Kjeld Søballe, Ph.D., MD.

  University Hospital of Aarhus

  STUDY CHAIR

• Poul T Nielsen, M.D.

  Northern Orthopaedic Division, Aalborg University Hospital, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

DK (1)