Compaction Total Hip Arthroplasty (THA) Bilateral

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00317889
First received: April 23, 2006
Last updated: January 21, 2016
Last verified: January 2016
  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:

Primary Outcome Measures:
  • Radiostereometric analysis [ Time Frame: 10 years follow-up ] [ Designated as safety issue: No ]
    Stem subsidence at 5 years measured with radiostereometric analysis


Secondary Outcome Measures:
  • Periprosthetic bone mineral density [ Time Frame: 5 years follow-up ] [ Designated as safety issue: No ]
    Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA)


Other Outcome Measures:
  • Questionnaire [ Time Frame: 5 years follow-up ] [ Designated as safety issue: No ]
    Questionnaire of hip function


Enrollment: 20
Study Start Date: May 2001
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2016 (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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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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

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: January 21, 2016
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 August 25, 2016