Compaction Total Hip Arthroplasty (THA) Bilateral

This study has been withdrawn prior to enrollment.
(The study is withdrawn due to lack of ressources)
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00317889
First received: April 23, 2006
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side.

Hypothesis: Compaction results in significantly less stem migration [evaluated by radiostereometric analysis (RSA)], less peri-prosthetic bone mineral density (BMD) loss [evaluated by dual energy x-ray absorptiometry (DEXA)], and a higher Harris hip score after two years.


Condition Intervention
Coxarthrosis
Procedure: Bone preparation technique: compaction
Procedure: Bone preparation technique: broaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compaction THA Bilateral

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

Enrollment: 0
Study Start Date: January 2004
Intervention Details:
    Procedure: Bone preparation technique: compaction
    Other Name: No other names.
    Procedure: Bone preparation technique: broaching
    Other Name: No other names.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary arthritis in the hip
  • Patients with sufficient bone density to allow uncemented implantation of a femoral component
  • Informed patient consent in writing

Exclusion Criteria:

  • Patients with neuromuscular or vascular disease in the affected leg
  • Patients found upon operation to be unsuited for uncemented acetabulum component
  • Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study
  • Patients with fracture sequelae
  • Female patients of childbearing capacity
  • Hip joint dysplasia
  • Sequelae to previous hip joint disorder in childhood.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317889

Locations
Denmark
Northern Orthopaedic Division
Aalborg and Farsø, Aalborg, Denmark, 8000
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
Principal Investigator: Søren Kold, MD Northern Orthopaedic Division
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00317889     History of Changes
Other Study ID Numbers: ON-04-002b-SKO
Study First Received: April 23, 2006
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: 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 23, 2014