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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
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 25, 2016
    Last Updated
    March 7, 2016
    Sponsor
    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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    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

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