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On the Impact of Bleeding on Two Strategies Osteosynthesis of Trochanteric Fractures

NCT01427036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-12-22

No results posted yet for this study

Summary

Fractures of the trochanter in the elderly have a terrible prognosis both vital and functional. It is certainly possible to reduce the medical and economic impact of this disease by reducing surgical trauma, by means of minimally invasive osteosynthesis material adapted to this approach. This minimally invasive approach should, however, guarantee a result at least equal to the standard approach. The goal is to have a technique, easily to transmit, using a percutaneous approach, but which may be converted to conventional surgery in case of difficulty, and with implants appropriate for trochanteric fractures.

With this in mind, the dynamic hip screw MISS® (Minimally Invasive Screw System) was developed and has already demonstrated its effectiveness in terms of anatomical results. It is as effective than the PHS® hip screw design for standard approach. The two implants have the same plate and screw and differ only by the system for fixing the screw on the plate to allow minimal invasive approach.

Conditions

  • Other Reconstructive Surgery

Interventions

PROCEDURE

MISS

Installation of the patient in the operating room (same technique for MISS and PHS) operated supine on a fracture table, a fluoroscope (C Arm) authorizing a control AP and lateral. Reduction of the fracture before incision (same technique for MISS and PHS): it is essential for minimally invasive surgery and inclusion in the study. One checked on the AP and the lateral view the absence of a fracture gap greater than the thickness of the the cortical. skin incision 6 to 8 cm in the axis of the proximal femur, beginning a little above trochanteric crest in, then incised longitudinally extensive externe1 cm under the sub trochanteric crest, on a length of 3 cm. Passage of the raspatory along thefemoral shaft under the muscle on the entire length of the plate.

PROCEDURE

PHS

Installation of the patient in the operating room (same technique for MISS and PHS) operated supine on a fracture table, a fluoroscope (C Arm) authorizing a control AP and lateral. Reduction of the fracture before incision (same technique for MISS and PHS): it is essential for minimally invasive surgery and inclusion in the study. One checked on the AP and the lateral view the absence of a fracture gap greater than the thickness of the the cortical. Surgical approach for PHS : Longitudinal external starting on trochanteric crest, long 15-20 cm depending on morphotype of the patient. Incision of the fascia latta like a " L " detaching the vastus lateralis to expose the external surface of the femur on the length of the plate.

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Philippe ROSSET, Pr · Service d'Orthopédie II - CHRU de TOURS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-08-31
Completion
2013-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01427036 on ClinicalTrials.gov