Fluoroscopy Improves Femoral Stem Placement
Fluoroscopy
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Fluoroscopy is routinely used in trauma cases to evaluate alignment and reduction quality. Because conventional templating has a high mismatch rate, the investigators sought to explore whether the investigators could use intraoperative fluoroscopy while implanting the femoral stem.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
Shorter than P25 for not_applicable
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
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 11, 2016
CompletedMarch 11, 2016
March 1, 2016
2 months
February 25, 2016
March 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
medial canal flare index ratios on computerized tomography images
The stem/endosteal areas at 2 cm above the trochanter minor (T+2) and 2 cm below the trochanter minor (T-2) and the deviation of the stem tip from the center of the femoral canal were evaluated on CT images
2 days after operation
Secondary Outcomes (4)
centralization of stem tip on computerized tomography images
2 days after operation
limb length discrepancy on X ray
1 day after operation
lateral offset on Xray
1 day after operation
alignment of stem on computerized tomography
2 days after operation
Study Arms (2)
hip prosthesis under fluoroscopy
ACTIVE COMPARATORimplantation of femoral stem of hip prosthesis in this group of patients are under fluoroscopic guidance for stem size and stem alignment and last rap before original stem implantation will be checked for alignment , lateral and vertical offsets parameters.
hip prosthesis without fluoroscopy
SHAM COMPARATORin this group of patients rasping of femoral canal during hip prosthesis is made via anatomic landmarks which confirmed by to senior surgeons and than original stem implanted.
Interventions
in active group femural stem of hip prosthesis will implanted under fluoroscopy guidance during operation till maximum rasp size reached that fills the medullary canal. ordinary 3-5 sequences per operation
all patients in the study will undergo hip prosthesis
Eligibility Criteria
You may qualify if:
- patients with hip osteoarthritis
You may not qualify if:
- malignant tumors, previously known bone disease, drug consumption affecting bone mineralization or Crowe type III hip dislocations with greater than 4 cm of LLD were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 25, 2016
First Posted
March 11, 2016
Study Start
November 1, 2015
Primary Completion
January 1, 2016
Study Completion
February 1, 2016
Last Updated
March 11, 2016
Record last verified: 2016-03