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Initial Experience with the T-Clamp for Temporary Fixation of Mechanically and Hemodynamically Unstable Pelvic Ring Injuries Aresh Sepehri , Marcus F. Sciadini , Jason W. Nascone , Theodore T. Manson , Robert V. O’Toole , Gerard P Slobogean PII: DOI: Reference:
S0020-1383(20)30055-3 https://doi.org/10.1016/j.injury.2020.01.030 JINJ 8540
To appear in:
Injury
Accepted date:
22 January 2020
Please cite this article as: Aresh Sepehri , Marcus F. Sciadini , Jason W. Nascone , Theodore T. Manson , Robert V. O’Toole , Gerard P Slobogean , Initial Experience with the TClamp for Temporary Fixation of Mechanically and Hemodynamically Unstable Pelvic Ring Injuries, Injury (2020), doi: https://doi.org/10.1016/j.injury.2020.01.030
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Highlights
The ‘trochanteric C-clamp’ (T-clamp) is a novel technique described for rapid stabilization of the pelvis while ensuring adequate access to the groin and abdomen. This case series presents the use of the T-clamp in 17 hemodynamically unstable patients requiring pelvic stabilization as well as emergent endovascular and abdominal procedures. T-clamp application offers a reasonably safe and effective method for expeditious stabilization of the pelvis, although caution should be applied in patients with concomitant acetabulum fracture for risk of malreduction. Additionally, its prolonged postoperative use should be limited to patients who are not immediately suitable for fixation of the pelvis.
Initial Experience with the T-Clamp for Temporary Fixation of Mechanically and Hemodynamically Unstable Pelvic Ring Injuries Aresh Sepehri,* MD, Marcus F. Sciadini,* MD, Jason W. Nascone,* MD, Theodore T. Manson,* MD, Robert V O’Toole,* MD, Gerard P Slobogean,* MD
*Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, MD Corresponding Author: Gerard P. Slobogean, MD, MPH, FRCSC, R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine, 6th Floor, Suite 300, 110 S. Paca St, Baltimore, MD
21201 (e-mail:
[email protected]). Disclosures No authors have any relevant disclosures. No sources of funding supported this study.
Keywords Unstable Pelvic Ring Injuries; Hemodynamically Unstable; Polytrauma; Temporary Pelvic Fixation Abstract In polytrauma patients with unstable pelvic ring injuries, pelvic binders interfere with femoral arterial access and are frequently removed for emergent endovascular and abdominal procedures. The ‘trochanteric C-clamp’ (T-clamp) is a novel technique described for rapid stabilization of the pelvis without fluoroscopic imaging, while ensuring adequate access to the groin. This case series reports the feasibility and safety following T-clamp application for unstable pelvic ring injuries in patients requiring simultaneous endovascular intervention. Between May 2018 – May 2019, seventeen patients with unstable pelvic ring injuries were treated with a T-clamp in conjunction with other emergent endovascular or intra-abdominal procedures. Nine presented with unstable APC injuries, seven with unstable LC injuries and one with a vertical shear pattern. Complications related to the T-clamp were prospectively collected. Following T-clamp application, there were two cases of intraoperative over-reduction, one of which required exchange for an anterior external fixator. This was the result of a concomitant acetabulum fracture leading to iatrogenic acetabular protrusion secondary to the T-clamp. Twelve cases maintained the T-clamp fixation postoperatively ranging from 1-3 days. One postoperative loss of reduction was noted and required exchange for anterior external fixator. In hemodynamically unstable patients who require emergent endovascular procedures, such as pelvic angiography and REBOA, T-clamp application offers a reasonably safe and effective method for expeditious stabilization of the pelvis while allowing unimpeded access to the abdomen, groin and pelvis. Caution should also be applied in patients with concomitant acetabulum fracture for risk of malreduction. Additionally, its prolonged postoperative use should be limited to patients who are not immediately suitable for fixation of the pelvis.
Introduction Unstable pelvic ring fractures are the result of high energy trauma and are often associated with other musculoskeletal and systemic injuries. Rapidly achieving pelvic stability and reducing the pelvic volume is an essential step in managing the hemodynamically unstable pelvic fracture patient.1,2 However, definitive reduction and fixation of the pelvis is often delayed in lieu of addressing more emergent injuries. Thus, numerous techniques for achieving temporary pelvic stability have been developed, including pelvic binders and external fixators. Pelvic binders (or sheets) are frequently the initial treatment of choice due to its universal availability and rapid application.3-5 However, in mechanically unstable pelvic fractures, the rate of arterial injury requiring pelvic angiography has been reported as high as 15%. 6-8 Additionally, although Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) was originally described in 1954,9 there has been increased clinical use recently of Zone 3 REBOA to manage pelvic bleeding.10,11 Femoral access is typically utilized for both of the above emergent endovascular interventions. Frequently, the pelvic binder or sheet interferes with access to the groin and is partially cut, moved to a lower and less mechanically advantageous position, or temporarily removed altogether. Removing the pelvic binder can increase the volume of the pelvis as much as 20%, 12,13 disrupting the tamponade effect produced by pelvic reduction and stabilization. In addition, concerns for skin necrosis often limit the amount of time pelvic binders and sheets are left in place. The C-clamp is a form of temporary external fixator that provides pelvic stabilization by securing pins in the anterior14 or posterior ilium.15,16 The major benefit of the C-clamp is the ability for the device to freely move around its axis, allowing unimpeded access to the abdomen, groins and perineum for emergent endovascular and laparotomy procedures. Archdeacon et al17 outlines the technique of the ‘trochanteric C-clamp’ (T-clamp) with pin placement into the greater trochanteric region of the femurs. This technique provides rapid stabilization of the pelvis without requiring immediate fluoroscopic
imaging. The purpose of this study is to report the feasibility and safety of emergent T-clamp application for mechanically unstable pelvic ring injuries in patients who require simultaneous emergent procedures. Materials and Methods This retrospective case series was conducted at a level 1 trauma center. Following approval from the Institutional Review Board, a review of patients with unstable pelvic ring injuries (AO/OTA 61-B2/3, 61-C) initially treated with emergent T-clamp stabilization (DePuy Synthes, West Chester, PA, USA) was conducted over one year from May 2018 – May 2019. Hospital charts and imaging studies were reviewed to collect data including basic patient demographics, fracture type, presenting lactate and systolic blood pressure, course in the trauma bay and operating room, and additional trauma interventions performed. Adverse events and complications associated with the T-clamp application were collected by the orthopaedic trauma team prospectively. Surgical Technique and Timing At the authors’ institution, trauma patients are immediately brought to the trauma bay where they are evaluated by the trauma team as per standard advanced trauma life support (ATLS) guidelines. At the time of pelvis fracture diagnosis, whether by AP radiograph or CT scan, the orthopaedic surgery team is notified and a pelvic binder is applied if not already applied by EMS or in the emergency department. For patients with unstable pelvic ring disruptions, the decision for definitive or temporary pelvic ring stabilization is determined by the patient status and need for more emergent trauma interventions. Temporary stabilization methods include pelvic binder, anterior pelvic external fixator, or T-clamp. In general, patients who sustain rotationally unstable pelvic ring injuries and present with hemorrhagic shock requiring emergent open abdomen or endovascular procedures, are typically converted from a binder to an external fixator in the operating room. However, when a patient is unable
to receive external fixation, due to physiologic extremis or the need for more emergent procedures, the T-clamp is considered by the orthopaedic surgeon. The T-clamp is applied as per the technique described by Archdeacon et al. 17 Briefly, holes are cut into the pelvic binder over the greater trochanters or a second binder is placed distally over the thighs; this ensures the pelvis remains reduced, preventing external rotation of the hemipelvis during clamp application. Palpating the greater trochanters, Kirschner wires are placed into the femur percutaneously. Incisions are made over the pin sites to slide the cannulated sleeves from the clamp over the Kirschner wires and engage the femur. The clamp is then locked in compression and the pelvic binder removed (Figure 1). Depending on immediate availability, reduction and fixation is assessed with an image intensifier at the completion of T-clamp application or at the conclusion of all more emergent trauma and vascular interventions. Descriptive statistics about the patient hemodynamic presentation, including systolic blood pressure and lactate, were performed using JMP V.12 software (SAS Institute, Cary, North Carolina, USA). Results Seventeen patients (16 male and one female) presented with an unstable pelvic ring injury and were treated with a temporary T-clamp. Table 1 displays the patient demographics and presenting injury details. The average age of the patients was 40 (range 18-69). Nine patients presented with unstable APC injuries, seven with unstable LC injuries and one with a vertical shear pattern. The median presenting systolic blood pressure was 92 mmHg (IQR: 80-114 mm Hg) and median initial lactate was 6.3 mmol/L (IQR: 5.1-9.5 mmol/L). In one case, the T-clamp was applied in the emergency department, and in the remainder of cases, the T-clamps were applied in the operating room emergently in conjunction with other endovascular and intra-abdominal procedures (Table 2). Fifteen patients underwent at least one
endovascular procedure: seven patients underwent REBOA insertion and 14 patients underwent pelvic angiography. Nine patients underwent open pelvic or abdominal procedures. All 17 patients received care from multiple services including the orthopaedic and the trauma team. In this series, all patients initially received temporary stabilization with T-clamp in conjunction with emergent trauma procedures, and were then re-evaluated at the conclusion of all initial interventions. Five patients were deemed stable enough to exchange the temporary T-clamp to alternative fixation: two received an anterior external fixator, two received posterior fixation by Sacroiliac screws, and one received definitive fixation by pubic symphysis plating and SI screws (Table 3). There were two cases of clamp-induced over-reduction following T-clamp application intraoperatively. In one case, this was corrected by adjusting the T-clamp. The other case had a concomitant transverse acetabular fracture, and compression with the T-clamp resulted in medialization of the caudal segment (Figure 2). The T-clamp was replaced by an anterior external fixator. Twelve cases maintained the T-clamp fixation postoperatively ranging from 1-3 days (Table 3). Three patients were deceased prior to definitive fixation and two patients underwent planned exchange for anterior external fixator the following day. There were three cases of loosening of the T-clamp postoperatively. In one case, the clamp was tightened and reduction was assessed with an AP pelvis radiograph without consequence. In the second case, the Kirschner wire had loosened from the femur and the T-clamp was removed and replaced with a pelvic binder. The third case returned to the operating room on postoperative day 1 for replacement with an anterior external fixator. Discussion This case series demonstrates that the novel technique, by Archdeacon et al, for trochanteric application of a C-clamp is a feasible and safe method for routine provisional pelvic ring stabilization in the hemodynamically unstable polytrauma patient. The application of the T-clamp can be performed by palpation without necessarily requiring immediate fluoroscopic guidance. Perhaps the greatest
advantage of utilizing the T-clamp is that it provides improved access to the groin and abdomen for other trauma procedures, particularly endovascular interventions such as pelvic angiography and REBOA. The use of endovascular intervention, particularly REBOA, is increasing at our center as it offers a method for managing, or at least temporizing, non-compressible hemorrhage in the torso and pelvis.18,19 All seventeen patients in our series underwent at least one additional endovascular or open abdominal procedure in addition to T-clamp application. No intraoperative complications regarding the T-clamp were noted with regards to interfering with these emergent trauma interventions. A major cause of mortality in polytrauma patients within 24 hours is hemorrhage. 20-22 For patients presenting with unstable pelvic ring injuries, blood loss is frequently due to disruption of the lumbosacral venous plexus in the retroperitoneum.1 Rapid reduction and stabilization of the pelvic ring reduces intrapelvic volume, allowing for tamponade and control of the hemorrhage. 2 Polytrauma patients often present with a pelvic binder in place or one is applied on arrival. Unfortunately, the pelvic binder can interfere with access to the groin or abdomen for other emergent procedures. Additionally, in the absence of continuous orthopaedic oversight, binders can be inappropriately removed during emergent general surgery or endovascular procedures. In our experience, the application of the T-clamp negates concerns of inappropriate removal or repositioning of a pelvic binder. The C-clamp was designed to rapidly control pelvic volume and allow rotation around its axis to provide access to the abdomen, groin and lower extremities. Initially the C-clamp was applied posteriorly by placing pins into the posterior ilium.15,16,23 Improvements in mean blood pressure and a reduction in the requirements for blood transfusion have been reported. 24 However, complications have also been reported following posterior C-clamp. Comminution in the posterior ring can potentially make posterior application ineffective. Furthermore, pin perforation through the ilium or dislodgement of pins into the schiatic notch is a relevant concern.25,26 Significant hematoma formation have been reported with the posterior pin placement.27 Knowledge of the anatomy is essential in proper pin placement to
avoid these complications. Lastly, the posterior pin placement creates open wound tracks that can potentially contaminate the definitive posterior fixation. The T-clamp offers several advantages compared to posterior C-clamp application. Anatomic landmarks can be difficult to palpate in the posterior pelvis depending on patient body habitus compared to the greater trochanter region. Secondly, the T-clamp can be applied without adjusting the pelvic binder by simply cutting holes over the greater trochanters. Once the T-clamp is secured, the pelvic binder can be removed. Although at this institution the T-clamp was most commonly applied in the OR, the device can be applied in the emergency department. Fluoroscopy is not required for the application of the T-clamp, but given the two cases of overreduction, the authors do recommend obtaining post-reduction pelvis films when able. Although application of the T-clamp at the greater trochanters is coplanar with both the pubic symphysis and the sacroiliac joints, the device is capable of producing significant compressive forces due to the ratcheting mechanism. This can result in significant internal rotation forces and over-reduction as was seen in case 2. The original C-clamp was designed to provide transverse compression directly over the iliosacral region by applying the clamp onto the posterior ilium. Utilizing this technique, the direction of the compressive force makes it nearly impossible to over-reduce the anterior ring. Instead, perforation through the ilium is the greater concern. Finally, it is important to clearly articulate the proposed indication for T-clamp use is emergent and brief temporary pelvic stabilization. In our case series, the T-clamp was left in situ postoperatively for up to 3 days. The authors do not recommend using the T-clamp for definitive fixation or even prolonged temporary fixation as the Kirschner wire and clamp configuration are not as robust as the external fixator pins and coupling devices used to secure the standard anterior pelvic external fixator. There were three cases of the clamp loosening postoperatively, one associated with the Kirschner wire breaking at the bone interface. Furthermore, lateral decubitus position is suboptimal with the T-clamp,
making prolonged ICU care difficult. In our institution, the T-clamp was maintained postoperatively only in patients who, following endovascular or abdominal procedures, were not suitable for continued operative intervention and required further resuscitation and re-evaluation prior to additional fixation of the pelvis. Only five patients were stable enough to immediately undergo definitive fixation or exchange for an anterior external fixator. There are limitations to this case series. Given its retrospective nature, the exact duration of Tclamp application is not recorded, as the patients in this series were often borderline or in extremis and undergoing multiple procedures simultaneously. Additionally, the complications associated with the Tclamp were informally collected prospectively for quality improvement purposes. Further limitations are that the sample size is limited and lacks a comparison group to quantify the benefits over previous practice. Lastly, patients undergoing T-clamp were selected by the surgeon through convenience sampling, introducing a potential selection bias. Ultimately, our initial experience with the Trochanteric C-clamp appears to demonstrate that it is a reasonably safe and effective method for expeditious stabilization of the pelvis. Due to the risk of pin loosening, patients should undergo definitive fixation or exchange with anterior external fixation following adequate resuscitation. Moreover, its prolonged postoperative use should be limited to patients who are not immediately suitable for fixation of the pelvis. Caution should also be applied in patients with concomitant acetabulum fracture. Nonetheless, in hemodynamically unstable patients who require emergent endovascular procedures, such as pelvic angiography and REBOA, T-clamp application may be another emergent temporizing treatment option to be considered as the clamp allows unimpeded access to the abdomen, groin and pelvis while providing a powerful reduction vector.
Conflict of Interest None of the authors have any conflicts of interest to declare. There were no financial or personal relationships with other people or organisations that could inappropriately influence (bias) this work. No funding was provided for this work.
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Manzano Nunez R, Naranjo MP, Foianini E, et al. A meta-analysis of resuscitative endovascular balloon occlusion of the aorta (REBOA) or open aortic cross-clamping by resuscitative thoracotomy in non-compressible torso hemorrhage patients. World journal of emergency surgery : WJES. 2017;12:30.
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Baque P, Trojani C, Delotte J, et al. Anatomical consequences of "open-book" pelvic ring disruption: a cadaver experimental study. Surgical and radiologic anatomy : SRA. 2005;27(6):487-490.
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Richard MJ, Tornetta P, 3rd. Emergent management of APC-2 pelvic ring injuries with an anteriorly placed Cclamp. Journal of orthopaedic trauma. 2009;23(5):322-326.
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Ganz R, Krushell RJ, Jakob RP, Kuffer J. The antishock pelvic clamp. Clinical orthopaedics and related research. 1991(267):71-78.
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Heini PF, Witt J, Ganz R. The pelvic C-clamp for the emergency treatment of unstable pelvic ring injuries. A report on clinical experience of 30 cases. Injury. 1996;27 Suppl 1:S-a38-45.
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Archdeacon MT, Hiratzka J. The Trochanteric C-Clamp for Provisional Pelvic Stability. Journal of orthopaedic trauma. 2006;20(1):47-51.
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Salcedo ES, Brown IE, Corwin MT, Galante JM. Pelvic angioembolization in trauma - Indications and outcomes. Int J Surg. 2016;33(Pt B):231-236.
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a
b
c
Figure 1. AP pelvis radiograph at initial presentation (a) and post T-clamp application (b) showing adequate reduction. Using palpation of the vastus ridge, Kirschner wires are inserted by battery drill through stab incisions bilaterally. Cannulated sleeves are placed over the wires down to bone and compression is applied via the clamp device. This provides adequate access to the abdomen, pelvis and groin for emergent procedures (c).
a
b
c
Figure 2. AP pelvis radiograph at initial presentation (a) showing an unstable pelvic ring fracture with an associated transverse and posterior wall acetabulum fracture. Following reduction with T-clamp, intraoperative fluoroscopy images (b) shows medialization of the femoral head. The T-clamp was replaced with an anterior pelvic external fixator after completion of an endovascular procedure (c).
Case
Sex
1
Age (years) 23
Mechanism of Injury
Presenting SBP (mmHg) 129
Presenting Lactate (mmol/L) 6.3
M
Pedestrian struck by motor vehicle
2
29
M
Fall from height approximately 60 feet
92
6.4
3
24
M
Motor vehicle collision
96
15.7
4
35
M
Fall from height approximately 60 feet
90
9.0
5
38
M
Pedestrian struck by motor vehicle
114
9.3
6
66
M
Motorcycle collision
80
4.8
7
43
M
Motor vehicle collision
59
11.2
8
40
F
Fall from height 40 feet
82
9.5
9
26
M
Motorcycle collision
95
17.0
10
60
M
Pedestrian struck by motor vehicle
77
6.3
11
46
M
Motorcycle collision
70
5.5
12
27
M
Motorcycle collision
115
3.6
13
60
M
Pedestrian struck by motor vehicle
107
3.8
14
18
M
Motor vehicle collision
80
5.3
15
56
M
Motorcycle collision
114
5.1
16
18
M
Motor vehicle collision
60
16.0
17
69
M
Motorcycle collision
116
2.9
Table 1. Patient and Injury Characteristics
Fracture Type AO/OTA (Young and Burgess Classification) 61-C1 (APC3) 61-C3 (bilateral APC3) 61-C2 (LC3) 61-B3 (APC2) 61-C2 (LC3) 61-B2 (LC2) 61-B2 (LC2) 61-B2 (LC2) 61-C1 (Vertical Shear) 61-B3 (Bilateral LC2) 61-C3 (APC3) 61-C3 (APC3 with contralateral APC2) 61-C3 (Bilateral APC3) 61-C3 (Bilateral APC3) 61-C3 (APC3 with contralateral APC2) 61-C2 (LC3) 61-C3 (Bilateral APC3)
Case
Trauma Interventions Performed at Initial Presentation in Addition to T-clamp
1
Pelvic angiography Definitive fixation performed at the conclusion of the trauma procedures
2
REBOA insertion Pelvic angiography
3
REBOA insertion Pelvic angiography with coil embolization Pelvic packing
4
Laparotomy and abdominal packing Pelvic angiography with coil embolization
5
Pelvic angiogram with coil embolization Laparotomy
6
REBOA insertion Pelvic angiography Laparotomy
7
Pelvic angiography with coil embolization
8
Laparotomy Bladder repair
9
Laparotomy with ligation of right internal iliac branches and hemicolectomy Pelvic angiography Bladder repair
10
REBOA insertion Laparotomy Pelvic angiography with coil embolization
11
REBOA insertion Laparotomy and abdominal packing Pelvic angiography with coil embolization
12
REBOA insertion Pelvic angiography with coil embolization
13
Pelvic angiography IVC filter insertion
14
Laparotomy with pelvic packing Clamshell thoracotomy with aortic cross-clamping
15
Pelvic angiography with coil embolization Above Knee Amputation
16
REBOA insertion Pelvic angiography with coil embolization
17
Pelvic angiography with coil embolization
Table 2. Emergent trauma interventions performed at initial OR presentation in addition to the T-clamp application
Case
Timing of Definitive Fixation
T-Clamp used as a reduction tool during definitive fixation
Days T-clamp in situ
1 2
Performed at Initial OR POD4
Yes No
3
POD3
No
4
N/A N/A
1
6
Deceased prior to definitive fixation Deceased prior to definitive fixation POD2
0 1 - replaced with anterior external fixator during subsequent trauma procedures 1 – replaced with anterior external fixator during subsequent trauma procedures 1
No
1
7
POD2
No
0 – replaced with anterior external fixator at conclusion of initial OR
8 9 10
Yes Yes N/A
3 0 3
11
POD3 Performed at Initial OR Deceased prior to definitive fixation POD3
No
12 13
Performed at Initial OR POD3
Yes Yes
0 – replaced with anterior external fixator at conclusion of initial OR 0 3
14
POD5
No
1
5
15 POD3 Yes 16 POD2 Yes 17 POD2 No Table 3. The duration of T-clamp use and complications.
3 2 2
Clamp Related Complications Initially over-reduced intraoperatively, required loosening and repeat reduction prior to conclusion of initial OR -
Kirschner wire broke postoperatively – replaced with pelvic binder Reduction resulted in medialization of the caudal segment of the transverse acetabulum fracture – Tclamp aborted and replaced with anterior external fixator -
Clamp and Kirschner wire loosened – repeat reduction was performed without issue Loss of Reduction postoperatively – exchanged for an anterior external fixator POD1 -