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

April 23, 2006
January 21, 2016
May 2001
September 2016   (final data collection date for primary outcome measure)
Radiostereometric analysis [ Time Frame: 10 years follow-up ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA)
Not Provided
Questionnaire [ Time Frame: 5 years follow-up ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
20
September 2018
September 2016   (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.
Both
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
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Northern Orthopaedic Division, Denmark
Northern Orthopaedic Division, Denmark
Not Provided
Principal Investigator: Søren Kold, MD Northern Orthopaedic Division
Northern Orthopaedic Division, Denmark
January 2016

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