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

NCT01427036 | Completed DMC

• 2 other identifiers: PHRI/09/PR/MISSvsPHSID RCB 2009-A00713-54
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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.

Conditions

Other Reconstructive Surgery

Outcome Measures

Primary Outcomes (1)

• 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 ΔHt + 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 ΔHt = (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 Outcomes (1)

• Clinical Criteria and Radiographic criteria

  3 months

Study Arms (2)

MISS surgery group

EXPERIMENTAL

hip screw MISS® (Minimally Invasive Screw System) : minimally invasive approach

Procedure: MISS

PHS surgery group

ACTIVE COMPARATOR

PHS® hip screw design for standard approach

Procedure: PHS

Interventions

MISS PROCEDURE

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.

Also known as: dynamic hip screw

MISS surgery group

PHS PROCEDURE

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.

Also known as: Pertrochanteric Hip Screw

PHS surgery group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (2)

CHU

Rennes, 35 203, France

Location

UH Tours CHRU Trousseau

Tours, 37 044, France

Location

Related Publications (1)

• Besnard M, Leger J, Babusiaux D, Marty F, Ropars M, Rosset P, Le Nail LR. Comparison of bleeding during trochanteric fracture fixation with mini-invasive or conventional side plate fixation: A randomized controlled trial. Orthop Traumatol Surg Res. 2023 Nov;109(7):103661. doi: 10.1016/j.otsr.2023.103661. Epub 2023 Jul 18.

  PMID: 37474020 RESULT

Study Officials

• Philippe ROSSET, Pr

  Service d'Orthopédie II - CHRU de TOURS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: September 1, 2011
• Study Start: June 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 22, 2025

Record last verified: 2018-10

Locations

FR (2)