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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
April 23, 2006
April 25, 2006
October 5, 2017
May 2001
September 2017   (Final data collection date for primary outcome measure)
Radiostereometric analysis [ Time Frame: 10 years follow-up ]
Stem subsidence at 5 years measured with radiostereometric analysis
Not Provided
Complete list of historical versions of study NCT00317889 on ClinicalTrials.gov Archive Site
Periprosthetic bone mineral density [ Time Frame: 5 years follow-up ]
Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA)
Not Provided
Questionnaire [ Time Frame: 5 years follow-up ]
Questionnaire of hip function
Not Provided
 
Compaction Total Hip Arthroplasty (THA) Bilateral
Compaction THA Bilateral

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coxarthrosis
  • Procedure: Bone preparation technique: compaction
    Other Name: No other names.
  • Procedure: Bone preparation technique: broaching
    Other Name: No other names.
  • Experimental: Compaction
    Compaction technique for femoral bone preparation prior to cementless femoral stem insertion.
    Intervention: Procedure: Bone preparation technique: compaction
  • Active Comparator: Broaching
    Broaching technique for femoral bone preparation prior to cementless femoral stem insertion.
    Intervention: Procedure: Bone preparation technique: broaching
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2017
September 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00317889
ON-04-002b-SKO
Not Provided
Not Provided
Not Provided
Northern Orthopaedic Division, Denmark
Northern Orthopaedic Division, Denmark
Not Provided
Principal Investigator: Søren Kold, MD Northern Orthopaedic Division
Northern Orthopaedic Division, Denmark
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP