Clinical trial NCT01427036: On the Impact of Bleeding on Two Strategies Osteosynthesis of Trochanteric Fractures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Reconstructive Surgery
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 108
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

Age greater than 65. Patient with a fracture of the trochanter, isolated fractures or other trauma may be increased blood loss.

Establishment of a screw-on plate hip had not had previous intervention Having signed an informed consent Member or beneficiary of a social security system Patient with the criteria for inclusion and pre- Reduced fracture on a fracture table before any incision.

Exclusion Criteria:

Delay between the onset of fracture and intervention than 7 days Polytrauma patient and "polyfracturé" Hip already made or with a degenerative, inflammatory, infectious or known or suspected tumor History of contralateral hip fracture within 12 months Impossible to reduce the fracture on a fracture table before incision History of pathology of coagulation known Proven history of allergy to LMWH

Primary outcomes:
measure: perioperative blood loss which is assessed between day 0 and day 5 by the following formula:
timeFrame: day 5
Secondary outcomes:
measure: Clinical Criteria and Radiographic criteria
timeFrame: 3 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU
city: Tours
country: France
facility: UH Tours CHRU Trousseau
Study officials:
affiliation: Service d'Orthopédie II - CHRU de TOURS
name: Philippe ROSSET, Pr
role: PRINCIPAL_INVESTIGATOR
References: