Comparison of bleeding during trochanteric fracture fixation with mini-invasive or conventional side plate fixation: A randomized controlled trial.
Blood loss
Hip fracture
Minimally invasive approach
Osteosynthesis
Trochanteric fracture
Journal
Orthopaedics & traumatology, surgery & research : OTSR
ISSN: 1877-0568
Titre abrégé: Orthop Traumatol Surg Res
Pays: France
ID NLM: 101494830
Informations de publication
Date de publication:
11 2023
11 2023
Historique:
received:
03
07
2022
revised:
04
03
2023
accepted:
06
06
2023
medline:
6
11
2023
pubmed:
21
7
2023
entrez:
20
7
2023
Statut:
ppublish
Résumé
Trochanteric fractures are a public health issue due to the aging of the population. Treatment aims to reduce their related morbidity and mortality and to allow an early return to independence. Postoperative anemia is associated with poorer functional recovery and an increased mortality rate. The aim of this study was to assess whether minimally invasive side plate fixation (Minimal Invasive Screw System, MISS™) resulted in reduced perioperative bleeding compared with conventional fixation (Pertrochanteric Hip Screw, PHS™). We hypothesized that minimally invasive side plate fixation (MISS) would result in reduced perioperative bleeding compared with conventional fixation (PHS). We conducted an open randomized controlled trial with blinded assessment of the primary outcome. Inclusion criteria were patients aged over 65 years with isolated reducible trochanteric fracture. The 2 surgical implants were of the same shape, the only difference between them being the locking mode of the femoral neck screw on the plate of the MISS device, allowing a percutaneous approach. Primary outcome was perioperative bleeding evaluated with Mercuriali's formula. Secondary outcomes included operating time, scar length, length of hospital stay, radiological criteria such as quality of fracture reduction, implant positioning, bone healing, complications and functional recovery compared between the 2 groups. One hundred and eight patients met the inclusion criteria and were randomized to receive either PHS (n=54) or MISS (n=54). Osteosynthesis with MISS significatively reduced perioperative bleeding (median 243mL, interquartile range [152-410] vs. 334mL [247-430] [p=0.0299]), operating time (65min [57-73] vs. 79min [66-89] [p=0.0002]) and scar length after 45 days (7cm [5-8] vs. 14cm [12-15] [p<0.0001]). There was no statistically significant difference between groups in postoperative complications, revision surgery or serious adverse events. Compared with PHS, MISS reduced operating time, perioperative bleeding and scar length with no observed functional difference. I.
Sections du résumé
BACKGROUND
Trochanteric fractures are a public health issue due to the aging of the population. Treatment aims to reduce their related morbidity and mortality and to allow an early return to independence. Postoperative anemia is associated with poorer functional recovery and an increased mortality rate. The aim of this study was to assess whether minimally invasive side plate fixation (Minimal Invasive Screw System, MISS™) resulted in reduced perioperative bleeding compared with conventional fixation (Pertrochanteric Hip Screw, PHS™).
HYPOTHESIS
We hypothesized that minimally invasive side plate fixation (MISS) would result in reduced perioperative bleeding compared with conventional fixation (PHS).
PATIENTS AND METHODS
We conducted an open randomized controlled trial with blinded assessment of the primary outcome. Inclusion criteria were patients aged over 65 years with isolated reducible trochanteric fracture. The 2 surgical implants were of the same shape, the only difference between them being the locking mode of the femoral neck screw on the plate of the MISS device, allowing a percutaneous approach. Primary outcome was perioperative bleeding evaluated with Mercuriali's formula. Secondary outcomes included operating time, scar length, length of hospital stay, radiological criteria such as quality of fracture reduction, implant positioning, bone healing, complications and functional recovery compared between the 2 groups.
RESULTS
One hundred and eight patients met the inclusion criteria and were randomized to receive either PHS (n=54) or MISS (n=54). Osteosynthesis with MISS significatively reduced perioperative bleeding (median 243mL, interquartile range [152-410] vs. 334mL [247-430] [p=0.0299]), operating time (65min [57-73] vs. 79min [66-89] [p=0.0002]) and scar length after 45 days (7cm [5-8] vs. 14cm [12-15] [p<0.0001]). There was no statistically significant difference between groups in postoperative complications, revision surgery or serious adverse events.
CONCLUSION
Compared with PHS, MISS reduced operating time, perioperative bleeding and scar length with no observed functional difference.
LEVEL OF EVIDENCE
I.
Identifiants
pubmed: 37474020
pii: S1877-0568(23)00152-4
doi: 10.1016/j.otsr.2023.103661
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT01427036']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
103661Informations de copyright
Copyright © 2023 Elsevier Masson SAS. All rights reserved.