Other Reconstructive SurgeryMISSvsPHSNCT01427036
On the Impact of Bleeding on Two Strategies Osteosynthesis of Trochanteric Fractures
A study testing MISS and PHS in people with Other Reconstructive Surgery, run by University Hospital, Tours at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Other Reconstructive Surgery
- What is being tested?
- MISS and PHS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2010to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Other Reconstructive Surgery
- Being tested
- MISS, PHS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MISSProcedure or surgery
Also called dynamic hip screw
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.
PHSProcedure or surgery
Also called Pertrochanteric Hip Screw
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.
| Study group | Role | What they receive |
|---|---|---|
| MISS surgery group | Experimental | hip screw MISS® (Minimally Invasive Screw System) : minimally invasive approach Receives: Procedure: MISS |
| PHS surgery group | Active comparator | PHS® hip screw design for standard approach Receives: Procedure: PHS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 5
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startJun 2010
- Primary completionAug 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Reconstructive SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe ROSSET, Pr, Principal investigator, Service d'Orthopédie II - CHRU de TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427036
- Sponsor's protocol ID
- PHRI/09/PR/MISSvsPHS
- Other IDs
- ID RCB 2009-A00713-54
- Acronym
- MISSvsPHS
- Status last verified
- Oct 2018
- First submitted
- 31 May 2011
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37474020
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01427036
- Acronym / sponsor ID
- MISSvsPHS / PHRI/09/PR/MISSvsPHS
- Conditions
- Other Reconstructive Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MISS surgery group | Experimental | Procedure: MISShip screw MISS® (Minimally Invasive Screw System) : minimally invasive approach |
| PHS surgery group | Active comparator | Procedure: PHSPHS® hip screw design for standard approach |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MISSAlso: dynamic hip screwInstallation 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 or surgery | MISS surgery group |
| PHSAlso: Pertrochanteric Hip ScrewInstallation 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. | Procedure or surgery | PHS surgery group |
Primary outcome
perioperative blood loss which is assessed between day 0 and day 5 by the following formula:
Time frame: day 5
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
1 secondary outcome
Clinical Criteria and Radiographic criteria
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 37474020Besnard 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.
Related trials for Other Reconstructive Surgery
Enrolling by invitationObservational study
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
Rheumatoid Arthritis, Osteoarthritis Shoulder
RecruitingObservational study
Donor Site Morbidity After Free Vascularized Fibular Graft
Osteosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe ROSSET, Pr principal investigator
Service d'Orthopédie II - CHRU de TOURS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MISS and PHS in people with Other Reconstructive Surgery, run by University Hospital, Tours at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perioperative blood loss which is assessed between day 0 and day 5 by the following formula: (time frame: day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01427036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.