The procedure was performed in a staged fashion in 20 patients, all undergoing spinal, sacropelvic, or spinopelvic reconstruction. In the 4 patients for whom the procedure was not staged, the mean operative time was 748 minutes (range, 617 to 930 minutes). Of the 20 patients who underwent a staged procedure, placement of the FVFG was performed at the time of tumor extirpation (n = 16), following a failed nonvascularized procedure (n = 3), or because of collapse of a lumbar vertebra following combined chemotherapy and proton therapy (n = 1). The staged procedure involves an anterior procedure (Stage 1), including mobilization of the bowel and vessels, exposure of the anterior surface of the sacrum, and osteotomies of the sacrum. Stage 2 is typically performed 2 days later (median, 2 days [range, 1 to 12 days] for the present cohort) and includes tumor resection and spinopelvic or sacropelvic stabilization35. In the current study, the mean operative time for the first stage was 612 minutes (range, 225 to 1,070 minutes) and for the second stage it was 818 minutes (range, 465 to 1,344 minutes). Two patients required a third stage, with a mean operative time of 922 minutes (range, 734 to 1,109 minutes).
The FVFG was placed to support the spinal column anteriorly (n = 18) or posteriorly (n = 2) or placed as an intercalary graft (n = 4). The fibula was supplemented with a single dual-posterior rod fixation (n = 14) or 4-rod posterior fixation (n = 8) or held in place with 2 compression screws (n = 2). Among the patients with a single dual-posterior rod fixation, the anterior column fixation was supplemented with a cage in 2 patients. A single vascular anastomosis was made between the fibula and the common iliac vessels (n = 8), gluteal vessels (n = 6), external iliac vessels (n = 4), aorta and vena cava (n = 2), epigastric vessels (n = 1), internal iliac vessels (n = 1), intercostal vessels (n = 1), and rectal vessels (n = 1). In 4 patients (all following total sacrectomy), bilateral FVFGs were used. The FVFG was placed as a “double-barrel” graft in 3 additional patients.
Neoadjuvant chemotherapy (n = 9) and neoadjuvant and adjuvant chemotherapy (n = 2) were used in patients at the discretion of the medical oncology staff on the basis of tumor pathology and according to modern treatment regimens. Radiation therapy was used preoperatively to assist with local control in 7 patients (mean dose, 54 Gy [range, 45 to 65 Gy]) and postoperatively in 2 (mean dose, 57 Gy [range, 50 to 63 Gy]). Three additional patients had a history of radiation therapy to the pelvis due to a malignancy and had subsequently developed post-radiation osteosarcoma (n = 2) or tumor recurrence (n = 1). One patient was treated definitively with combined proton-beam radiation therapy and chemotherapy for a central Ewing sarcoma and subsequently developed collapse and fracture of the L5 vertebra. The mean time from the completion of radiation therapy to FVFG placement for the latter 4 patients was 7 years (range, 2 to 16 years).
Patients were followed longitudinally after reconstruction. Repeat imaging was performed to evaluate for osseous union, hardware failure, and metastatic disease every 3 months for the first 2 years, every 6 months for years 2 through 5, and yearly thereafter. Imaging consisted of a computed tomography (CT) scan of the chest, spine, and pelvis. Likewise, magnetic resonance imaging (MRI) with gadolinium contrast of the spine and/or pelvis was obtained to assess for local disease recurrence. If the patient was not able to travel to our institution, the surveillance images were sent for review. In our patient cohort, 3 (13%) of the patients had not been seen for >5 years since the last follow-up visit and were considered lost to follow-up. The mean follow-up for the surviving patients was 5 years (range, 1 to 15 years).
Data compiled from the medical record included patient demographic information, the indication for the procedure, histological diagnosis, fixation technique, postoperative complications, and time to osseous union. Union was defined as external bridging callus at the docking sites or the absence of, and/or indistinct, osteotomy lines on CT scans36. Clinical and functional outcome was measured using the Musculoskeletal Tumor Society (MSTS) 1993 score37. Reoperation was defined as a procedure in which the surgical site containing the FVFG was operated on, but the FVFG was retained. All tumor pathology was reviewed by musculoskeletal pathologists.
Statistical Methods
The Kaplan-Meier method was used to estimate the rates of overall survival and disease-free survival. Patients undergoing a reconstruction for metastatic disease (n = 1) or a hematological malignancy (n = 1) were removed from the disease-free analysis. Multivariate regression analysis was not performed because of the limited number of events.
Results
Overall and Disease-Specific Survival
Over the course of the study, 6 patients died of disease and 1 patient died as a result of a complication from the surgical procedure. The mean time to death was 2 years (range, 4 days to 8 years). The overall 2, 5, and 10-year rate of survival for spinal and pelvic reconstruction with use of an FVFG following tumor resection was 76%, 55%, and 37%, respectively.
Distant metastasis occurred in 3 (13%) of the patients; distant metastasis and local recurrence, in 2 (8%); and isolated local recurrence, in 3 (13%). One of the patients with distant disease had a hematogenous malignancy and developed another osseous lesion. Not including this patient, the overall 2, 5, and 10-year rate of disease (distant metastasis or local recurrence)-free survival following spinal or pelvic reconstruction with use of an FVFG was 81%, 72%, and 48%, respectively. The most common site for recurrence was the lungs (n = 4, 17%).
Reoperation
Reoperation occurred in 12 (50%) of the patients at a mean of 4 months (range, 1 day to 2 years) following the FVFG placement. The most common indication for a repeat procedure was irrigation and debridement of a wound complication (n = 7, 58%). In addition to the reoperations, a CT-guided spinal drain was placed in 2 patients for a spinal fluid leak and a CT-guided drain was placed for an abscess in 1 patient. The fixation was revised in 3 patients at a mean of 1 year (range, 5 months to 2 years) postoperatively. Each of these 3 patients had a single dual-posterior rod reconstruction, and either the fibular graft was fractured (n = 2) or union had not yet occurred (n = 1). Following revision of the hardware to a 4-rod posterior reconstruction, union of the graft occurred in 1 patient; the other patient died from metastatic disease prior to union. The remaining patient was revised to a single posterior rod reconstruction but died prior to union.
Graft Union
Following FVFG placement, the rate of union was 86%, with a mean time to union of 7 months (range, 3 to 14 months). Three patients died prior to union and were not included in the analysis of union. One patient required a reoperation for repeat bone-grafting 8 months postoperatively, but the FVFG was retained and subsequently went on to union. The FVFG failed in 1 patient because of thrombosis of the pedicle. The thrombosed pedicle was noticed on irrigation and debridement of a wound complication. This graft was not revised but was left as a nonvascularized graft and went on to pseudarthrosis. Two patients developed a nonunion; however, these patients were not symptomatic.
Postoperative Complications
Following the FVFG procedure, 20 (83%) of the patients sustained at least 1 postoperative complication (Table I), with multiple complications occurring in 10 (42%) of the patients. The most common complications included wound dehiscence (n = 6), deep infection (n = 5), hardware failure (n = 4), and graft fracture (n = 3). Of the patients with a 4-rod reconstruction, there were no cases of FVFG fracture or hardware failure. All patients with a preoperative history of radiation therapy sustained a local postoperative complication (100% versus 62%), most commonly a wound complication (n = 5) and infection (n = 2).
Donor-site complications include a temporary peroneal nerve palsy (n = 1) and donor-site wound dehiscence (n = 1).
Functional Outcome
At the time of the last follow-up, the mean MSTS rating was 53% (range, 13% to 87%), with 15 (63%) of the patients demonstrating walking independently or with the use of a gait aid. In examining the MSTS rating throughout the course of recovery, the mean MSTS improved between the 6-month (mean, 44%; range, 23% to 67%) and 1-year (mean, 51%; range 20% to 73%) postoperative marks. The mean MSTS then remained similar at the 2-year (mean, 50%; range, 13% to 87%) postoperative mark.
Discussion
Since the 1970s, the FVFG has become the most utilized vascularized bone graft of the extremities; however, its use in the spine and pelvis is limited6-9,26-33,36,38-43. Given the complexity of such reconstructions, the use of an FVFG poses unique challenges in the spine and pelvis during reconstruction following tumor resections. However, given the complex biomechanics, proximity to many vital anatomic structures, and poor host tissue following radiation therapy, the use of vascularized structural bone-grafting has the potential to play an important role in the spine and pelvis. Currently there is a paucity of data concerning the use of FVFGs in the reconstruction of oncological defects in the spine and pelvis. The purpose of this study was to specifically look at the outcome of reconstruction using an FVFG following wide local resection of a malignant process of the spine and pelvis. In our series, the use of an FVFG provided successful spinal and pelvic reconstruction, albeit with a high rate of complications.
Because of its ability to hypertrophy, an FVFG is able to resist the high compressive stresses of the anterior column of the spine in the setting of large osseous defects12,26. In animal models, the use of FVFGs compared with nonvascularized grafts was found to be superior in terms of improved union with host bone as well as improved stability and stiffness, which was shown to continue to improve over time44,45. The results of the current study highlight the ability to use an FVFG in the spine and pelvis for segmental defects, despite the limited indications, complex resections, and small percentage of patients who require this form of reconstruction.
The use of an FVFG in reconstruction of oncological defects of the spine and pelvis is extremely limited26,28-30. Following resection of lower spinal and sacral tumors, the continuity between the spine and pelvis is often disrupted. Historically, a majority of sacropelvic tumors required a hindquarter amputation to achieve acceptable margins; however, limb salvage surgery can be achieved without compromising the oncological outcome14,15,46,47. With advances in imaging, surgical technique, and adjuvant treatments, the ability to preserve the limb and restore spinopelvic continuity has been improved. The maintenance of spinopelvic continuity is critical in these reconstructions because of the biomechanical disadvantages attributed to losing the sacrum and the inability to transfer the load of the body to the lower extremities14,15,48-50. Despite the prevalence of postoperative complications, an FVFG was successfully used to reestablish spinopelvic continuity. We consider the biology of the FVFG to be important in supplementing the fixation to establish spinopelvic continuity because of the ability of the graft to hypertrophy, with preservation of mechanical properties over time.
The reconstruction of large spinal and pelvic defects has historically been supplemented with the use of allograft struts, either fibular or tibial30,47,51-54. The use of allogenic bone grafts following oncological resection has been fraught with complications due to the avascular and acellular nature of the bone, with a high risk of fracture and nonunion55,56. Fracture of the FVFG occurred in 3 patients in our series and was likely related to the use of a biomechanically inferior single dual-posterior-rod reconstruction. Thus, we advocate for the use of a linked 4-rod posterior reconstruction to supplement the fixation of the FVFG, which has been found to be biomechanically superior to a 2-rod technique57. The improved stability is especially important during the early phases of osseous healing and incorporation, when all 3 of the fractures occurred.
Patient function following large spinopelvic and sacropelvic resections has been shown to be related to the level of spinal and sacral nerves resected58,59. The patients in this series had either a total sacrectomy, hemisacrectomy, or external hemipelvectomy with sacrifice of the corresponding nerve roots, or sacrifice of corresponding spinal nerve roots in the lumbar and thoracic spine related to their resection level. Following reconstruction, we noted variation in the functional outcome of patients, although there was no difference on the basis of the location of reconstruction. Although we do not have a direct comparison, compared with a historic series of pelvic reconstructions14, the use of an FVFG resulted in a majority of the patients having a higher “satisfactory” result, with a mean rating of 53%.
Neoadjuvant radiation therapy is associated with a substantially elevated risk of postoperative wound complications60. Even with flap coverage, wound complications are a known risk factor following sacrectomy or external hemipelvectomy61-63. Hillmann et al.63 noted an elevated risk of postoperative wound complications following neoadjuvant radiation therapy in patients undergoing pelvic tumor resection. This is similar to the results of this series, wherein all patients with a history of neoadjuvant radiation therapy sustained a postoperative complication, most commonly a wound complication.
There were several limitations to this study. The complex nature of these cases and their limited indications restrict the ability to perform a prospective study, even making a multicenter study difficult to perform. Because of the small number of patients and limited indications, there was substantial selection bias in the patients presented. There was no comparison group in this series; however, we believe that the addition of a biological FVFG is extremely important to increase biomechanical strength compared with use of an allograft in these large reconstructions. Although all patients had at least 1 year of clinical follow-up, there was the potential for increased rates of complications and tumor recurrence with longer follow-up. Because of the retrospective nature of the study, we are limited in the data that we were able to collect from the medical record and constrained in the analysis that we were able to perform. Although this study was performed at 1 institution, the procedures were performed by multiple surgical teams. In addition, union of the fibular graft was judged by the treating surgeons, and thus, there was detection bias. Likewise, because the study was performed at a single center, it limits the generalizability of our findings.
Despite the high rate of complications, the use of an FVFG in reconstruction was able to provide patients with a durable means of spinopelvic and sacropelvic reconstruction at mid-term follow-up. Currently, the use of an FVFG is our reconstructive bone graft of choice for segmental defects of the spine and pelvis to obtain spinopelvic continuity. We now utilize a 4-rod construct to increase biomechanical stability through an anticipated long healing process and to minimize the risk of catastrophic failure from breakage of a single-rod construct.
Investigation performed at the Mayo Clinic, Rochester, Minnesota
Disclosure: No external funding was received for this study. The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/D409).
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