Fluoroscopy Improves Femoral Stem Placement

NCT ID: NCT02706002

Last Updated: 2016-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-02-29

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.

Conditions

Osteoarthritis, Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hip prosthesis under fluoroscopy

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.

Group Type: ACTIVE_COMPARATOR

fluoroscopy

Intervention Type: 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

Intervention Type: PROCEDURE

all patients in the study will undergo hip prosthesis

hip prosthesis without fluoroscopy

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.

Group Type: SHAM_COMPARATOR

hip prosthesis

Intervention Type: PROCEDURE

all patients in the study will undergo hip prosthesis

Interventions

fluoroscopy

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: DEVICE

hip prosthesis

all patients in the study will undergo hip prosthesis

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role: lead

Responsible Party

Haluk Çabuk

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

OkmeydaniTRH

Identifier Type: -

Identifier Source: org_study_id