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Early fracture fixation is the critical factor in fracture healing. Common internal fracture implants are made of metallic materials, which often affects the imaging quality of CT and MRI. Most patients will choose secondary surgery to remove the internal fixation implants, which causes secondary damage to them. The development of new degradable internal fracture implants has attracted more and more attention from orthopedic surgeons and researchers. Based on these problems, we improved the various properties of medical grade polycaprolactone (PCL) by adding poly(L-lactide) (PLLA). We produced PCL/PLLA strapping bands with different mass ratios by injection molding. We compared the mechanical properties, degradation properties, cell biocompatibility, bone marrow mesenchymal stem cells (BMSCs) adhesion, proliferation, osteogenic differentiation and fracture fixation effect of these strapping bands. The results showed that the tensile strength and yield force of the strapping bands increased with the increase of the content of PLLA. The addition of PLLA could significantly improve the mechanical strength in the early stage and accelerate the degradation rate of the strapping band. PCL/PLLA (80/20) strapping band had no significant cytotoxicity toward rBMSCs and could promote osteogenic differentiation of rBMSCs. The strapping band could ensure femoral fracture healing of beagles in 3 months and didn’t cause damage to the surrounding tissues and main organs. This study will provide some new insights into the biodegradable products of PCL/PLLA blends for internal fixation of fracture. Graphical Abstract
Early fracture fixation is the critical factor in fracture healing. Common internal fracture implants are made of metallic materials, which often affects the imaging quality of CT and MRI. Most patients will choose secondary surgery to remove the internal fixation implants, which causes secondary damage to them. The development of new degradable internal fracture implants has attracted more and more attention from orthopedic surgeons and researchers. Based on these problems, we improved the various properties of medical grade polycaprolactone (PCL) by adding poly(L-lactide) (PLLA). We produced PCL/PLLA strapping bands with different mass ratios by injection molding. We compared the mechanical properties, degradation properties, cell biocompatibility, bone marrow mesenchymal stem cells (BMSCs) adhesion, proliferation, osteogenic differentiation and fracture fixation effect of these strapping bands. The results showed that the tensile strength and yield force of the strapping bands increased with the increase of the content of PLLA. The addition of PLLA could significantly improve the mechanical strength in the early stage and accelerate the degradation rate of the strapping band. PCL/PLLA (80/20) strapping band had no significant cytotoxicity toward rBMSCs and could promote osteogenic differentiation of rBMSCs. The strapping band could ensure femoral fracture healing of beagles in 3 months and didn’t cause damage to the surrounding tissues and main organs. This study will provide some new insights into the biodegradable products of PCL/PLLA blends for internal fixation of fracture. Graphical Abstract
Background Limiting reoperation or revision after operative stabilization or endoprosthetic reconstruction of a pathologic subtrochanteric femur fracture reduces morbidity, but how best to achieve this remains controversial. Endoprosthetic reconstruction offers durable mechanical stability but may not be most appropriate in patients who are frail or who are not expected to survive more than a few months. For that reason, cumulative incidence survival (looking at the endpoint of reoperation or revision with death as a competing risk) and factors associated with revision after surgical stabilization or reconstruction—both of which remain poorly characterized to date—would help surgeons make better decisions on behalf of these patients. Questions/purposes We analyzed patients who were operatively treated for pathologic subtrochanteric femur fracture, and we asked: (1) What is the cumulative incidence of reoperation and revision at 3 months, 1 year, and 2 years after surgery for pathologic subtrochanteric femur fracture in patients undergoing each treatment type with death as a competing risk? (2) What are the factors associated with implant revision after operative treatment of pathologic subtrochanteric femur fracture? (3) What is the overall survival of patients in this population after surgery? (4) How do clinical and surgical factors along with the frequency of complications compare in this population by operative treatment? Methods Between January 2000 and December 2020, 422 patients underwent surgery for completed proximal femur pathologic fractures. After excluding patients with non-subtrochanteric femur fractures (71% [301]), fractures caused by primary tumors of bone (< 1% [2]), and insufficient data (1% [6]), we included 113 patients who underwent operative treatment of completed pathologic subtrochanteric femur fractures. Our study period spanned 20 years because although implant trends may have shifted, the overall operative objective for pathologic subtrochanteric femur fractures—restoring function and alleviating pain, regardless of the extent of bony union—have remained relatively unchanged during this period. Median follow-up time was 6 months (range 1 month to 20.6 years). Intramedullary nailing (IMN) was performed in 68% (77) of patients, proximal femur replacement (PFR) was performed in 19% (22), and open reduction and internal fixation (ORIF) was performed in 12% (14) of patients. IMN was performed in patients with a poor prognosis but in whom fracture stabilization was felt to be advantageous. In instances of complex fractures in which adequate reduction could not be achieved, ORIF was generally performed. PFR was generally performed in patients with a better prognosis in which long-term implant survival and patient function were prioritized. We found a higher proportion of women in the IMN group (73% versus 32% in PFR and 50% in ORIF; p = 0.001). Rapid growth tumors (Katagiri classification) were found in 25% of patients with IMN, 27% with PFR, and 43% with ORIF. The primary outcome was the cumulative incidence of reoperation or revision surgery after initial stabilization. Competing risk analysis with death as a competing event was performed to estimate the cumulative incidence for reoperation and revision. Factors associated with revision surgery were identified using the Cox proportional hazards model, which rendered HRs. All analyses were adjusted to control for potential confounders. Results The cumulative incidence for reoperation at 2 years was 5% (95% confidence interval [CI] 4% to 6%) for IMN, 15% (95% CI 9% to 22%) for PFR, and 32% (95% CI 15% to 50%) for ORIF (p = 0.03). The cumulative incidence for revision at 2 years was 4% (95% CI 3% to 4%) for IMN, 4% (95% CI 2% to 6%) for PFR, and 33% (95% CI 15% to 51%) for ORIF (p = 0.01). Factors associated with revision surgery were radioresistant tumor histology (HR 8.5 [95% CI 1.2 to 58.9]; p = 0.03) and ORIF (HR 6.3 [95% CI 1.5 to 27.0]; p = 0.01). The 3-month, 1-year, and 2-year overall survival was 80% (95% CI 71% to 87%), 35% (95% CI 26% to 45%), and 28% (95% CI 19% to 36%), respectively. Thirty-day postoperative complications did not differ by fixation type, but 90-day readmission was highest after ORIF (3 of 14 versus 4 of 22 in PFR and 4% [3 of 77] in IMN; p = 0.03) Periprosthetic joint infection (PJI) was more common after salvage PFR (2 of 6) than primary PFR (1 of 22) (p = 0.04). Conclusion Primary PFR may be preferred for pathologic subtrochanteric femur fractures arising from radioresistant tumor types, as the cumulative incidence of revision was no different than for IMN while restoring function, alleviating pain, and offering local tumor control, and it less commonly develops PJI than salvage PFR. In complex fractures not amenable to IMN, surgeons should consider performing a PFR over ORIF because of the lower risk of revision and the added benefit of replacing the pathologic fracture altogether and offering immediate mechanical stability with a cemented endoprosthesis. Future studies might evaluate the extent of bone loss from local tumor burden, and this could be quantified and analyzed in future studies as a covariate as it may clarify when PFR is advantageous in this population. Level of Evidence Level III, therapeutic study.
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