Fluoroscopy Improves Femoral Stem Placement (Fluoroscopy)
Primary Purpose
Osteoarthritis, Hip
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fluoroscopy
hip prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip
Eligibility Criteria
Inclusion Criteria:
- patients with hip osteoarthritis
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
hip prosthesis under fluoroscopy
hip prosthesis without fluoroscopy
Arm Description
implantation 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.
in 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
centralization of stem tip on computerized tomography images
distance of stem tip from the center of medullary canal in millimeters
limb length discrepancy on X ray
distance between interteardrop line to trochanter minor on anteroposterior x rays
lateral offset on Xray
distance between trochanter major tip and hip's center of rotation
alignment of stem on computerized tomography
the angle between axis of femoral canal and axis of stem
Full Information
NCT ID
NCT02706002
First Posted
February 25, 2016
Last Updated
March 7, 2016
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1. Study Identification
Unique Protocol Identification Number
NCT02706002
Brief Title
Fluoroscopy Improves Femoral Stem Placement
Acronym
Fluoroscopy
Official Title
Fluoroscopy Improves Femoral Stem Placement in Cementless Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Prospectively two groups of patients with hip osteoarthritis were included in the study. Hip osteoarthritis was classified according to the Croft classification. The investigators primary goal is to evaluate T+ 2 ( 2 cm above trochanter minor) results between the two groups. Standard effect sizes (standard effect size) assumed to be at least 0.75. 30 cases for each group took power with 80% margin of 5% error. Patients with malignant tumors, previously known bone disease, drug consumption affecting bone mineralization or Crowe type III hip dislocations with greater than 4 cm of limb length discrepancy (LLD) were excluded. Prior to the operation, all patients underwent an X ray investigation to exclude any bone abnormalities. All patients were operated by the same team, which was composed of two senior surgeons and 2 fellows. Patients with odd-numbered were the first group and even numbers were the second group in order of receipt surgery. All patients were operated on the lateral decubitus position with a posterior approach and a metaphyseal locking femoral stem (Depuy Synthess SUMMIT Tapered Hip System, US). In the first group, no preoperative templating was performed, and the final conformation of the stem size and position was decided freehand intraoperatively based on anatomic landmarks. In the second group, there was also no preoperative templating, but after both senior surgeons agreed on the final stem size intraoperatively, C-arm fluoroscopy images were obtained with the last rasp size before stem implantation. The alignment and stem fitting of the femoral canal were evaluated. While evaluating the limb leg discrepancy anterior - posterior fluoroscopy image must include both hips and both lesser trochanters. Once this was achieved, the interteardrop line was used and vertical distance between interteardrop line and lesser trochanters measured for limb length discrepancy. Horizontal distance between tip of trochanter major and center of rotation was evaluated as lateral offset. For stem alignment, the femoral stem axis being parallel with the axis of the femoral canal was assessed. Also centralization of femoral stem tip in the femoral canal was assessed. Determination of stem was assessed according to full contact of broach teeth in sub trochanteric region. The stem was size changed unless all criteria above was achieved on fluoroscopy. After the operation, all patients were evaluated with X ray and CT(computerized tomography).
Medial canal flare index (MCFI) can be used for metaphyseal lacking femoral stems. The alignment of the femoral stem with the femoral canal, the limb length discrepancy ( LLD) and the lateral offsets were evaluated on X ray. 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(Computerized tomography) images.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hip prosthesis under fluoroscopy
Arm Type
Active Comparator
Arm Description
implantation 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.
Arm Title
hip prosthesis without fluoroscopy
Arm Type
Sham Comparator
Arm Description
in 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.
Intervention Type
Device
Intervention Name(s)
fluoroscopy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
hip prosthesis
Intervention Description
all patients in the study will undergo hip prosthesis
Primary Outcome Measure Information:
Title
medial canal flare index ratios on computerized tomography images
Description
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
Time Frame
2 days after operation
Secondary Outcome Measure Information:
Title
centralization of stem tip on computerized tomography images
Description
distance of stem tip from the center of medullary canal in millimeters
Time Frame
2 days after operation
Title
limb length discrepancy on X ray
Description
distance between interteardrop line to trochanter minor on anteroposterior x rays
Time Frame
1 day after operation
Title
lateral offset on Xray
Description
distance between trochanter major tip and hip's center of rotation
Time Frame
1 day after operation
Title
alignment of stem on computerized tomography
Description
the angle between axis of femoral canal and axis of stem
Time Frame
2 days after operation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with hip osteoarthritis
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Fluoroscopy Improves Femoral Stem Placement
We'll reach out to this number within 24 hrs