Hip Int 2014; 24 ( 2): 200-205
DOI: 10.5301/hipint.5000096
ORIGINAL ARTICLE
Traumax screw plate vs. Gamma nail. Blood loss in pertrochanteric fractures treated by minimally invasive osteosynthesis Nicolas Reina, Laurent Geiss, Régis Pailhé, Laurent Maubisson, Jean-Michel Laffosse, Philippe Chiron Pierre Paul Riquet Hospital, Musculoskeletal Institute, CHU Toulouse, Toulouse - France
Purpose: This study is aimed to determine whether the Traumax dynamic hip screw reduces perioperative blood loss and transfusion rate compared to the Gamma nail in the treatment of pertrochanteric fractures. Materials and methods: A series of 331 patients were followed prospectively in a cohort study between February 2008 and October 2011 after a pertrochanteric fracture. Two types of fixation were used, 163 patients were treated with a Gamma nail and 168 patients with a minimally invasive screw plate Traumax. Perioperative blood loss, evaluated by the Mercuriali formula based on pre- and postoperative haemoglobin and transfusion rates were compared in order to assess risk factors. Results: Increased perioperative blood loss was significantly linked with patient-related parameters (age, anticoagulant and platelet aggregation inhibitor treatment). Type of osteosynthesis and type of fracture were also risk factors for blood loss and transfusion. The Traumax group had significantly lower blood loss (347 ml vs. 577 ml) and transfusion rate (33.9% vs. 63.8%) than the Gamma group. Involvement of the greater trochanter increased the risk of blood loss only in the Gamma group. Functional results and bone healing were comparable at six months follow-up. Conclusion: Screw plate Traumax significantly reduces perioperative bleeding after pertrochanteric fractures. It avoids fracture gaps that tend to maintain bleeding. Given the morbidity and complications related to acute anaemia and blood transfusion, the surgical management of these elderly patients is aided by this choice of fixation. Keywords: Trochanteric fractures, Minimally invasive surgical procedures, Bleeding, Elderly Accepted: July 23, 2013
INTRODUCTION Pertrochanteric fractures account for a third to half of fractures of the upper femoral extremity, which is the most common injury in traumatology (1). A mortality around 20% (2) is seen at one year in these elderly, frail patients who have numerous comorbid conditions. Acute anaemia is a major risk factor for decompensation of comorbid conditions and leads to delayed return to normal activity. Transfusion is also recognised as being correlated with an increased 200
risk of death in orthopaedic surgery (3). A certain number of risk factors for blood loss are well codified. The type of fixation device and type of fracture could also influence the amount of perioperative blood loss in this population. We compared blood loss after pertrochanteric fracture in elderly subjects treated with a minimally invasive intramedullary fixation device, the Gamma nail® (Stryker Trauma®, Geneva, Switzerland) and a minimally invasive extramedullary device, the Traumax® dynamic hip screw (DHS) (Integra LifeSciences®, NJ, USA).
© 2014 Wichtig Publishing - ISSN 1120-7000
Reina et al
Hypothesis
ume was estimated using Nadler’s formula (6) taking into account the patient’s sex, as follows:
The Traumax DHS reduces perioperative blood loss and transfusion rate compared with the Gamma nail in the treatment of pertrochanteric fractures.
PATIENTS AND METHODS A series of 331 patients were enrolled in a cohort study and prospectively followed between February 2008 and October 2011. All presented with a pertrochanteric fracture. Patients were consecutively enrolled to one treatment group. Group one consisted of 163 patients treated with a Gamma nail and the second group 168 patients treated with the Traumax DHS. Forty-two patients were excluded and two patients declined to participate in the study.
Exclusion criteria Sub- or intertrochanteric fractures or true cervical fractures, pathological fractures, patients with acute infection, patients with a comorbid condition endangering their functional or vital prognosis, an ASA score of 4 or 5, time from fracture to surgery of more than eight days and patient refusal to participate in the study. Two patients declined to participate. The same team of five senior surgeons and three anaesthetists carried out all procedures in the same surgical facility. Osteosynthesis was carried out with traction on an orthopaedic table. No postoperative drainage was used. Fractures were classified according to the OTA classification (4) and Evans classification as modified by Jensen (5). For analysis, patients were also divided into groups according to involvement (Jensen type 3, 5 or OTA 31-A1.2, A2.2, A2.3) or non-involvement (Jensen type 1, 2, 4 or OTA 31-A1.1, A1.3, A2.1) of the greater trochanter. Patient demographic data was recorded (age, sex, weight, height, BMI, preoperative haematocrit and haemoglobin level, ASA score) and extrinsic data (type of osteosynthesis, treatment with anticoagulants or platelet aggregation inhibitors, time between injury and surgery, duration of surgery).
Blood loss calculation Total blood loss was calculated from change in haematocrit level and estimated total blood volume. Total blood vol-
Women: blood volume (l) = height (m)3 x 0.3561 + weight (kg) x 0.03308 + 0.1833 Men: blood volume (l) = height (m)3 x 03669 + weight (kg) x 0.03219 + 0.6041. Perioperative blood loss was calculated using the Mercuriali formula (7). Compensation for blood loss by transfusion was estimated by assuming that all allogeneic blood units transfused had the same red cell content. Blood loss (l) = TBV (l) x (Htpreop – Htpostop) x 100 + nBU x 0.2 where TBV is total blood volume, Ht haematocrit and nBU the number of allogeneic blood units transfused. An allogeneic blood unit was considered to have a constant red cell content equivalence of 0.2 l. Blood loss was calculated as red blood cell loss. Laboratory tests were carried out preoperatively and five days postoperatively (±1 day) in the same laboratory. Management of fluid and electrolyte balance and of blood transfusion was decided by the anaesthetic team, who were blinded to the type of fixation device. Transfusion was indicated when the haemoglobin level was less than 9 g/dl or when clinical tolerance of blood loss was poor (dyspnoea, orthostatic hypotension, angina, tachycardia).
Surgical technique The Gamma nail is an intramedullary device and the operative technique consists of inserting the cephalic screw after introducing the nail through the greater trochanter. Distal locking is performed with an external ancillary kit percutaneously with a non-locking screw. The Traumax DHS involves the insertion of a cephalic screw with a modular barrel after the plate has been placed in contact with the femur (Fig. 1). The plate, the cephalic screw and distal fixation screws are inserted by a unique lateral approach, using a guide pin for the three locking screws.
Statistical analysis The null hypothesis tested was that a minimally invasive Traumax DHS leads to comparable blood loss for pertrochanteric fractures compared to a Gamma intramedullary nail in terms of calculated blood loss and transfusion rate.
© 2014 Wichtig Publishing - ISSN 1120-7000
201
Blood loss in pertrochanteric fractures: Traumax vs. Gamma
TABLE I - COMPARISON OF THE TRAUMAX AND GAMMA PATIENT GROUPS
Sample size
Traumax
Gamma
168
163
T test
P value
Age
80.8 ± 12.56
85.8 ± 19.49 -2.746 0.006*
Weight (kg)
61.9 ± 14.03
60.6 ± 13.88 0.826
0.409
Height (cm)
162.8 ± 8.39
161.3 ± 9.28
1.483
0.139
BMI
23.3 ± 4.53
23.2 ± 4.62
0.065
0.948
Time from fracture to surgery (hours)
34.1 ± 26.74 29.3 ± 19.12
1.88
0.061
Duration of surgery (min) 44.8 ± 13.94 34.4 ± 12.57
7.167
DOI: 10.5301/hipint.5000096
ORIGINAL ARTICLE
Traumax screw plate vs. Gamma nail. Blood loss in pertrochanteric fractures treated by minimally invasive osteosynthesis Nicolas Reina, Laurent Geiss, Régis Pailhé, Laurent Maubisson, Jean-Michel Laffosse, Philippe Chiron Pierre Paul Riquet Hospital, Musculoskeletal Institute, CHU Toulouse, Toulouse - France
Purpose: This study is aimed to determine whether the Traumax dynamic hip screw reduces perioperative blood loss and transfusion rate compared to the Gamma nail in the treatment of pertrochanteric fractures. Materials and methods: A series of 331 patients were followed prospectively in a cohort study between February 2008 and October 2011 after a pertrochanteric fracture. Two types of fixation were used, 163 patients were treated with a Gamma nail and 168 patients with a minimally invasive screw plate Traumax. Perioperative blood loss, evaluated by the Mercuriali formula based on pre- and postoperative haemoglobin and transfusion rates were compared in order to assess risk factors. Results: Increased perioperative blood loss was significantly linked with patient-related parameters (age, anticoagulant and platelet aggregation inhibitor treatment). Type of osteosynthesis and type of fracture were also risk factors for blood loss and transfusion. The Traumax group had significantly lower blood loss (347 ml vs. 577 ml) and transfusion rate (33.9% vs. 63.8%) than the Gamma group. Involvement of the greater trochanter increased the risk of blood loss only in the Gamma group. Functional results and bone healing were comparable at six months follow-up. Conclusion: Screw plate Traumax significantly reduces perioperative bleeding after pertrochanteric fractures. It avoids fracture gaps that tend to maintain bleeding. Given the morbidity and complications related to acute anaemia and blood transfusion, the surgical management of these elderly patients is aided by this choice of fixation. Keywords: Trochanteric fractures, Minimally invasive surgical procedures, Bleeding, Elderly Accepted: July 23, 2013
INTRODUCTION Pertrochanteric fractures account for a third to half of fractures of the upper femoral extremity, which is the most common injury in traumatology (1). A mortality around 20% (2) is seen at one year in these elderly, frail patients who have numerous comorbid conditions. Acute anaemia is a major risk factor for decompensation of comorbid conditions and leads to delayed return to normal activity. Transfusion is also recognised as being correlated with an increased 200
risk of death in orthopaedic surgery (3). A certain number of risk factors for blood loss are well codified. The type of fixation device and type of fracture could also influence the amount of perioperative blood loss in this population. We compared blood loss after pertrochanteric fracture in elderly subjects treated with a minimally invasive intramedullary fixation device, the Gamma nail® (Stryker Trauma®, Geneva, Switzerland) and a minimally invasive extramedullary device, the Traumax® dynamic hip screw (DHS) (Integra LifeSciences®, NJ, USA).
© 2014 Wichtig Publishing - ISSN 1120-7000
Reina et al
Hypothesis
ume was estimated using Nadler’s formula (6) taking into account the patient’s sex, as follows:
The Traumax DHS reduces perioperative blood loss and transfusion rate compared with the Gamma nail in the treatment of pertrochanteric fractures.
PATIENTS AND METHODS A series of 331 patients were enrolled in a cohort study and prospectively followed between February 2008 and October 2011. All presented with a pertrochanteric fracture. Patients were consecutively enrolled to one treatment group. Group one consisted of 163 patients treated with a Gamma nail and the second group 168 patients treated with the Traumax DHS. Forty-two patients were excluded and two patients declined to participate in the study.
Exclusion criteria Sub- or intertrochanteric fractures or true cervical fractures, pathological fractures, patients with acute infection, patients with a comorbid condition endangering their functional or vital prognosis, an ASA score of 4 or 5, time from fracture to surgery of more than eight days and patient refusal to participate in the study. Two patients declined to participate. The same team of five senior surgeons and three anaesthetists carried out all procedures in the same surgical facility. Osteosynthesis was carried out with traction on an orthopaedic table. No postoperative drainage was used. Fractures were classified according to the OTA classification (4) and Evans classification as modified by Jensen (5). For analysis, patients were also divided into groups according to involvement (Jensen type 3, 5 or OTA 31-A1.2, A2.2, A2.3) or non-involvement (Jensen type 1, 2, 4 or OTA 31-A1.1, A1.3, A2.1) of the greater trochanter. Patient demographic data was recorded (age, sex, weight, height, BMI, preoperative haematocrit and haemoglobin level, ASA score) and extrinsic data (type of osteosynthesis, treatment with anticoagulants or platelet aggregation inhibitors, time between injury and surgery, duration of surgery).
Blood loss calculation Total blood loss was calculated from change in haematocrit level and estimated total blood volume. Total blood vol-
Women: blood volume (l) = height (m)3 x 0.3561 + weight (kg) x 0.03308 + 0.1833 Men: blood volume (l) = height (m)3 x 03669 + weight (kg) x 0.03219 + 0.6041. Perioperative blood loss was calculated using the Mercuriali formula (7). Compensation for blood loss by transfusion was estimated by assuming that all allogeneic blood units transfused had the same red cell content. Blood loss (l) = TBV (l) x (Htpreop – Htpostop) x 100 + nBU x 0.2 where TBV is total blood volume, Ht haematocrit and nBU the number of allogeneic blood units transfused. An allogeneic blood unit was considered to have a constant red cell content equivalence of 0.2 l. Blood loss was calculated as red blood cell loss. Laboratory tests were carried out preoperatively and five days postoperatively (±1 day) in the same laboratory. Management of fluid and electrolyte balance and of blood transfusion was decided by the anaesthetic team, who were blinded to the type of fixation device. Transfusion was indicated when the haemoglobin level was less than 9 g/dl or when clinical tolerance of blood loss was poor (dyspnoea, orthostatic hypotension, angina, tachycardia).
Surgical technique The Gamma nail is an intramedullary device and the operative technique consists of inserting the cephalic screw after introducing the nail through the greater trochanter. Distal locking is performed with an external ancillary kit percutaneously with a non-locking screw. The Traumax DHS involves the insertion of a cephalic screw with a modular barrel after the plate has been placed in contact with the femur (Fig. 1). The plate, the cephalic screw and distal fixation screws are inserted by a unique lateral approach, using a guide pin for the three locking screws.
Statistical analysis The null hypothesis tested was that a minimally invasive Traumax DHS leads to comparable blood loss for pertrochanteric fractures compared to a Gamma intramedullary nail in terms of calculated blood loss and transfusion rate.
© 2014 Wichtig Publishing - ISSN 1120-7000
201
Blood loss in pertrochanteric fractures: Traumax vs. Gamma
TABLE I - COMPARISON OF THE TRAUMAX AND GAMMA PATIENT GROUPS
Sample size
Traumax
Gamma
168
163
T test
P value
Age
80.8 ± 12.56
85.8 ± 19.49 -2.746 0.006*
Weight (kg)
61.9 ± 14.03
60.6 ± 13.88 0.826
0.409
Height (cm)
162.8 ± 8.39
161.3 ± 9.28
1.483
0.139
BMI
23.3 ± 4.53
23.2 ± 4.62
0.065
0.948
Time from fracture to surgery (hours)
34.1 ± 26.74 29.3 ± 19.12
1.88
0.061
Duration of surgery (min) 44.8 ± 13.94 34.4 ± 12.57
7.167
