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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This study has been withdrawn prior to enrollment.
(The study is withdrawn due to lack of ressources)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

April 23, 2006
March 28, 2014
January 2004
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Complete list of historical versions of study NCT00317889 on ClinicalTrials.gov Archive Site
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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.

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Interventional
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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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00317889
ON-04-002b-SKO
Not Provided
Northern Orthopaedic Division, Denmark
Northern Orthopaedic Division, Denmark
Not Provided
Principal Investigator: Søren Kold, MD Northern Orthopaedic Division
Northern Orthopaedic Division, Denmark
March 2014

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