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

Other Reconstructive Surgery Clinical Trial

Official title: Impact Sur le Saignement Per et Post opératoire de 2 stratégies d'ostéosynthèse Des Fractures du Massif trochantérien du Sujet > 65 Ans : Essai randomisé Comparant le système MISS et le système PHS

Status Completed

Clinical Trial 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.

Clinical Trial Description

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.

The main objective of the study is to show that the use of dynamic hip screw MISS is associated with lower morbidity (in terms of bleeding) in comparison with the material PHS standard (Pertrochanteric Hip Screw) implanted by standard approach.

The secondary objectives are :

• Check the quality of reduction and stability of osteosynthesis with the MISS are equivalent to those of the PHS.

• Assessing the economic impact on the duration of use of operating rooms and the length of hospitalization

The study is a randomized trial with multicenter parallel group with collection of blinded endpoint : PROBE Study (Prospective Randomized Blinded Endpoint), comparing two techniques : minimally invasive approach versus standard approach, Apart from the incision, and the system fixing the screw to the plate, all other periods of the operation will be identical. Operation is done on table fracture with X-rays control with C arm. Associated therapies will be identical in both groups and follow the protocols of the department.

Number of patients : 54 in each group = 108 patients Duration of the research Duration of the inclusion period: 21 months Duration of participation for each patient: three months Total duration of the study: 24 months

Expected effects :

For patients: intervention better supported, postoperative more simple, shortened length of stay and faster rehabilitation.

For the hospital: intervention shorter and simpler, lower occupation time of block, decreased average length of stay.

For society: reduced cost of care of these patients by society ;

Related Conditions & MeSH terms

• Other Reconstructive Surgery

• NCT number: NCT01427036
• Study type: Interventional
• Source: University Hospital, Tours
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Completion date: November 2013