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Clinical Trials/NCT00318396
NCT00318396
Unknown
Not Applicable

Compaction Femur Total Hip Arthroplasty (THA) Uni-lateral

Northern Orthopaedic Division, Denmark1 site in 1 country26 target enrollmentJune 2004
ConditionsCoxarthrosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coxarthrosis
Sponsor
Northern Orthopaedic Division, Denmark
Enrollment
26
Locations
1
Primary Endpoint
To examine a possible difference in density of bones around implantation of femoral component.
Last Updated
9 years ago

Overview

Brief Summary

This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who receive a unilateral total hip replacement are randomized to either conventional broaching or compaction.

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.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
December 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Northern Orthopaedic Division, Denmark
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

To examine a possible difference in density of bones around implantation of femoral component.

Time Frame: 5 years

A check-up by means of DEXA scanning after 1 week, 1 year, 2 years and 5 years.

Study Sites (1)

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