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

Other Reconstructive Surgery Clinical Trial

— MISSvsPHS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427036
• Other study ID #: PHRI/09/PR/MISSvsPHS
• Secondary ID: ID RCB 2009-A007
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: November 2013

Study information

• Verified date: October 2018
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Other Reconstructive Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU	Rennes
France	UH Tours CHRU Trousseau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perioperative blood loss which is assessed between day 0 and day 5 by the following formula:	Primary outcome measure : It is defined by the perioperative blood loss which is assessed between day 0 and day 5 by the following formula: PBL = BVT x ?Ht + 150 x PRBC where: PBL = Perioperative Blood Loss (mL) between day 0 and day 5 BVT = Blood Volume Theorical (mL) = 70ml/kg humans, 65ml/kg in non-obese women ?Ht = (preoperative hematocrit at D0) - (Hct on day 5 postoperative) 150 (ml) = average volume of unit of Packed Red Blood Cells PRBC = number of Packed Red Blood Cells administered to the patient	day 5
Secondary	Clinical Criteria and Radiographic criteria	secondary outcome measure; Clinical Criteria: Duration of hospitalization; Onset of complications not attributable to implant during hospitalization (thrombo-embolic. ..).; Intra-and postoperative complication related to the implant (fracture implant, migration of implant removal).; Length of the incision; Duration of intervention (incision to closure); Rates of surgical site infection; Need for reoperation Radiographic criteria; Reduction of the fracture on X-Rays (AP and latéral); Position of implants; Consolidation; Secondary displacement	3 months