Compaction Total Hip Arthroplasty (THA) Bilateral
Compaction THA Bilateral
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedFirst Submitted
Initial submission to the registry
April 23, 2006
CompletedFirst Posted
Study publicly available on registry
April 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedDecember 19, 2020
December 1, 2020
16.3 years
April 23, 2006
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiostereometric analysis
Stem subsidence (change) at 5 and 10 years measured with radiostereometric analysis
5 and 10 years follow-up
Secondary Outcomes (1)
Periprosthetic bone mineral density
5 years follow-up
Other Outcomes (1)
Questionnaire
5 years follow-up
Study Arms (2)
Compaction
EXPERIMENTALCompaction technique for femoral bone preparation prior to cementless femoral stem insertion.
Broaching
ACTIVE COMPARATORBroaching technique for femoral bone preparation prior to cementless femoral stem insertion.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northern Orthopaedic Division
Aalborg and Farsø, Aalborg, 8000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Søren Kold, MD
Northern Orthopaedic Division
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2006
First Posted
April 25, 2006
Study Start
May 1, 2001
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
December 19, 2020
Record last verified: 2020-12