Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2001-05-31
2017-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Compaction
Compaction technique for femoral bone preparation prior to cementless femoral stem insertion.
Bone preparation technique: compaction
Broaching
Broaching technique for femoral bone preparation prior to cementless femoral stem insertion.
Bone preparation technique: broaching
Interventions
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Bone preparation technique: compaction
Bone preparation technique: broaching
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with sufficient bone density to allow uncemented implantation of a femoral component
* Informed patient consent in writing
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Northern Orthopaedic Division, Denmark
OTHER
Responsible Party
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Principal Investigators
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Søren Kold, MD
Role: PRINCIPAL_INVESTIGATOR
Northern Orthopaedic Division
Locations
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Northern Orthopaedic Division
Aalborg and Farsø, Aalborg, Denmark
Countries
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Other Identifiers
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ON-04-002b-SKO
Identifier Type: -
Identifier Source: org_study_id
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