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Completed

NCT Number: NCT02706002

Fluoroscopy Improves Femoral Stem Placement

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluoroscopy

Device

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

hip prosthesis

Procedure

all patients in the study will undergo hip prosthesis

Primary outcomes

  1. medial canal flare index ratios on computerized tomography images

    Time frame: 2 days after operation

    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 outcomes

  1. centralization of stem tip on computerized tomography images

    Time frame: 2 days after operation

    distance of stem tip from the center of medullary canal in millimeters

  2. limb length discrepancy on X ray

    Time frame: 1 day after operation

    distance between interteardrop line to trochanter minor on anteroposterior x rays

  3. lateral offset on Xray

    Time frame: 1 day after operation

    distance between trochanter major tip and hip's center of rotation

  4. alignment of stem on computerized tomography

    Time frame: 2 days after operation

    the angle between axis of femoral canal and axis of stem

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

Fluoroscopy Improves Femoral Stem Placement in Cementless Total Hip Arthroplasty

Acronym: Fluoroscopy

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2016
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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