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This study has been withdrawn prior to enrollment.
(The study is withdrawn due to lack of ressources)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
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: 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 July 20, 2014