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Compaction Total Hip Arthroplasty (THA) Bilateral

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00317889
First Posted: April 25, 2006
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compaction THA Bilateral

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

Primary Outcome Measures:
  • Radiostereometric analysis [ Time Frame: 10 years follow-up ]
    Stem subsidence at 5 years measured with radiostereometric analysis


Secondary Outcome Measures:
  • Periprosthetic bone mineral density [ Time Frame: 5 years follow-up ]
    Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA)


Other Outcome Measures:
  • Questionnaire [ Time Frame: 5 years follow-up ]
    Questionnaire of hip function


Enrollment: 20
Study Start Date: May 2001
Study Completion Date: September 2017
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Compaction
Compaction technique for femoral bone preparation prior to cementless femoral stem insertion.
Procedure: Bone preparation technique: compaction
Other Name: No other names.
Active Comparator: Broaching
Broaching technique for femoral bone preparation prior to cementless femoral stem insertion.
Procedure: Bone preparation technique: broaching
Other Name: No other names.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00317889     History of Changes
Other Study ID Numbers: ON-04-002b-SKO
First Submitted: April 23, 2006
First Posted: April 25, 2006
Last Update Posted: October 5, 2017
Last Verified: October 2017

Keywords provided by Northern Orthopaedic Division, Denmark:
THA

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