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Abaloparatide and pelvic fracture healing: a phase 2 randomized placebo-controlled trial
Nieves, Jeri W; Cosman, Felicia; McMahon, Donald; Berman, Heather; Bartolotta, Roger J; Kazam, J Jacob; Hentschel, Isabelle; Egol, Kenneth; Forsh, David; Zhu, Yuan-Shan; Yoo, Jae Eun; Lane, Joseph
UNLABELLED:Pelvic fractures result in prolonged pain and immobility. In a randomized controlled trial of patients with pelvic fracture, whether abaloparatide (ABL) vs. placebo (PBO) improves healing at 3 months was evaluated. There was no significant difference in CT radiologic healing, physical performance, or change in pain in ABL vs. placebo. PURPOSE/OBJECTIVE:To determine if abaloparatide (ABL) vs. placebo (PBO) improves radiologic healing, pain, and functional outcome at 3 months in patients with pelvic fracture. METHODS:Postmenopausal women and men ≥ 50 years old, enrolled within 4 weeks of pelvic fracture (n = 48), were randomized to blinded ABL vs. PBO. The primary endpoint, fracture healing at 3 months, was assessed by two radiologists using a 5-point scale for cortical bridging from CT images comparing groups by Jonckheere-Terpstra test. The odds of healing (3 or 4 cortices bridged) were analyzed with Mantel-Haenszel relative risks (RR). Pain was assessed monthly by Numeric Rating Scale (NRS). The Short Physical Performance Battery (SPPB; walk speed, chair stands, and balance) evaluated functional mobility. RESULTS:Groups were balanced with a mean age = 82, 93% were female, 98% had multiple rami fractures, 67% had sacral fracture, and 36% had ≥ 1 displaced fracture. CT images at 3 months showed no significant difference in bridging score distribution (indicator of healing) in patients with ABL vs. PBO (p = 0.15) after adjusting for age, sacral fracture, displacement, or compliance. When evaluating individual fractures (n = 81), similar bridging scores were seen with ABL and PBO (p = 0.13). When patients were stratified as healed or not healed, 39% were healed with ABL and 64% healed with PBO (RR 0.61; 95% CI 0.33, 1.12). When looking at the 81 individual fractures, 47% were healed with ABL and 53% healed with PBO (RR = 0.88; 95% CI 0.55, 1.40). Using least square means controlling for age, sacral, and displaced fracture, NRS pain score was higher in the placebo than the ABL group at baseline (p < 0.05), but there were no further group differences in change in pain score SPPB and TUG scores improved over time in both groups without group differences. CONCLUSION/CONCLUSIONS:In this small study, there was no significant difference in CT radiologic healing, physical performance, or change in pain with ABL vs. placebo in patients with acute pelvic fracture. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov identifier: NCT04249232 registered January 27, 2020.
PMID: 42618812
ISSN: 1433-2965
CID: 6071482
A double-hit analysis: Evaluating the nephrotoxicity of dual intravenous and vancomycin impregnated cement exposure
Vu, Natalie H; Esper, Garrett W; Egol, Kenneth A; Ganta, Abhishek; Konda, Sanjit R
PURPOSE/OBJECTIVE:The concomitant use of postoperative intravenous vancomycin (IVV) in patients treated with vancomycin-impregnated cement (VIC) may represent a "double hit" contributing to nephrotoxicity, yet its impact on acute kidney injury (AKI) remains unclear. This study evaluated whether postoperative IVV in patients treated with VIC is associated with increased AKI incidence (primary outcome) and greater changes in serum creatinine (secondary outcome) compared with VIC alone. METHODS:A retrospective cohort study was conducted at a multi-hospital academic health system from 2012 to 2024. Adults undergoing VIC implantation for fracture-related infection were grouped by postoperative IVV exposure (IVV+VIC versus VIC alone). AKI was defined using Kidney Disease: Improving Global Outcomes (KDIGO) creatinine-based criteria. Secondary outcomes included mean absolute and percent serum creatinine change. A subgroup analysis evaluated 81 patients with chronic kidney disease (CKD). Multivariable regression adjusted for baseline creatinine, tobramycin dose, CKD, ASA class, and VIC dose. RESULTS:A total of 589 patients were included: 326 (55.4%) received IVV + VIC and 263 (44.6%) received VIC alone, with similar baseline characteristics. Among IVV + VIC patients, mean IV vancomycin dose was 1160 mg (SD 354) over a mean of 6.6 doses (SD 7.6), with a mean VIC dose of 4.9 g (SD 3.3). The VIC alone group had a mean VIC dose of 4.3 g (SD 3.3). AKI incidence did not differ between groups (18.1% vs 14.5%, p = 0.282). However, IVV + VIC was associated with greater mean absolute (0.19 vs 0.00 mg/dL, p < 0.001) and percent serum creatinine change (17.98 vs -0.86). Among CKD patients, AKI rates were similarly elevated in both cohorts (56.8% vs 40.5%, p = 0.216). On multivariable analysis, IVV + VIC was not independently associated with AKI (OR=1.37, 95% CI 0.84-2.23, p = 0.207) but was associated with greater absolute (β = 0.182, 95% CI 0.082-0.282, p < 0.001) and percent creatinine change (β = 17.683, 95% CI 9.659-25.706, p < 0.001). CONCLUSION/CONCLUSIONS:Postoperative IV vancomycin in patients treated with vancomycin-impregnated cement was not associated with increased AKI risk. While dual antibiotic therapy resulted in greater creatinine elevations, AKI risk appeared driven primarily by underlying renal disease. These findings support cautious use of dual therapy with close renal monitoring, particularly in patients with pre-existing CKD.
PMID: 42603393
ISSN: 1879-0267
CID: 6071331
Single lag screw cephalomedullary nail angle-anatomy mismatch is associated with immediate postoperative malreduction after intertrochanteric hip fracture fixation
Fisher, Nina; Hammond, Benjamin; Lashgari, Alexander; Goldstein, Amelia; Ganta, Abhishek; Egol, Kenneth; Konda, Sanjit
PURPOSE/OBJECTIVE:To determine whether cephalomedullary nail (CMN) angle was associated with malreduction after intertrochanteric (IT) fracture fixation. Secondarily, to explore if CMN angle was associated with fixation failure (FF). METHODS:A retrospective comparative review was conducted of patients ≥ 65 years old with low energy falls and OTA/AO 31-A fractures treated with a CMN from 12/01/2016-06/30/2024 at a single academic institution (four hospitals). The primary outcome was immediate postoperative malreduction (IPM)-the absolute difference between post-fixation neck-shaft angle (NSA) and native contralateral NSA being ≥ 3°. The secondary outcome was FF. Univariate analyses compared IPM between 125° and 130° CMNs. Multivariable regression was performed to determine if CMN angle was associated with IPM, and as an exploratory analysis, FF. RESULTS:A total of 277 patients were included with follow-up of 18.2 ± 15.1 months. The 125° CMN group had significantly greater age, body mass index (BMI), and American Society of Anesthesiologists score (ASA). There was a higher incidence of IPM with 125° CMNs (p = 0.02). Among patients with native NSA ≥ 130°, those treated with a 125° nail had significantly higher IPM incidence (p = 0.01). Mean IPM did not differ by CMN angle. Logistic regression found that BMI (OR 1.06, p = 0.04) and 125° CMN angle (OR 1.82, p = 0.05) were associated with IPM. FF rates were similar between CMN angle groups, but failures had greater varus IPM than non-failures (p = 0.02). In the exploratory FF regression model, CMN angle and varus IPM were not associated with failure, while larger native NSA was associated with FF (OR 1.16, p < 0.001). CONCLUSION/CONCLUSIONS:125° and 130° nails achieved similar mean fracture alignment, yet 125° nails were more frequently associated with varus malreduction, especially with native valgus neck-shaft angles. After adjusting for confounders, higher BMI and 125° nails were associated with malreduction but not with fixation failure.
PMID: 42439991
ISSN: 1432-1068
CID: 6066352
Posterior Tibial Tendon Transfer and Achilles Tendon Lengthening for Foot Drop [Case Report]
Mercer, Nathaniel P; Lezak, Bradley A; Lowe, Dylan T; Egol, Kenneth A
This review describes a case of chronic post-traumatic foot drop managed with posterior tibial tendon transfer through the interosseous membrane and percutaneous Achilles tendon lengthening. Key technical considerations and postoperative rehabilitation principles are highlighted. This approach provides a durable solution for restoring ankle dorsiflexion and improving ambulation in patients with irreversible peroneal nerve injury.
PMID: 42466779
ISSN: 1531-2291
CID: 6067362
Comparison of Early Bracing Versus Splinting for the Initial Treatment of Acute Humeral Shaft Fractures (The COBRAS Trial)
Kingery, Matthew T; Ganta, Abhishek; Egol, Kenneth A
OBJECTIVES/OBJECTIVE:To compare 2 methods of initial immobilization of closed humeral shaft fractures-coaptation splinting followed by delayed functional bracing and immediate functional bracing-with respect to pain, satisfaction, and skin-related complications during the initial 10-day post-injury period. DESIGN/METHODS:Multicenter, randomized, two-arm, parallel clinical trial. SETTING/METHODS:One academic medical center with 2 Level 1 academic trauma centers and 1 tertiary care orthopaedic center. PATIENT SELECTION CRITERIA/UNASSIGNED:Patients with acute, closed humeral shaft fractures (AO/OTA 12A, 12B, 12C) were randomized to either initial coaptation splinting followed by delayed transition to Sarmiento bracing or immediate Sarmiento bracing. OUTCOME MEASURES AND COMPARISONS/UNASSIGNED:Pain intensity over time measured by a patient-reported Likert scale (numerical rating scale, 0-10) once daily at the same time during the first 10 days post-injury, skin-related complications (skin damage ranging from abrasion or blistering to full-thickness skin loss secondary to pressure from the splint or brace), analgesic consumption in morphine milligram equivalent (MME), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function scores, and patient satisfaction. RESULTS:Fifty-eight patients were included in the analysis with a mean age of 48.8 ± 23.9 years (mean 50.5 years [range 18.4-92.2 years] in the coaptation splint group vs. mean 47.3 years [range 19.7-85.9 years] in the immediate Sarmiento brace group). Patients in the immediate Sarmiento bracing group reported significantly higher pain scores compared with coaptation splinting during the first 10 days postinjury (mean treatment effect = 0.97 points, 95% CI [0.26-1.69], P = 0.010; Figure 3). Cumulative opioid consumption over the 10-day period was similar between groups (median 20.0 MME for the coaptation splint group vs. 32.5 MME for the Sarmiento brace group, P = 0.308). PROMIS Physical Function scores were not significantly different between groups on postinjury day 7 (median 53.0 [IQR 44.5-68.5] for the splint group vs. 51.1 [IQR 45.0-60.5] for the brace group, P = 0.756). The rate of skin-related complications was higher in the Sarmiento brace group (33.3% vs. 7.1%, P = 0.022). Patient satisfaction scores at day 7 were not significantly different between groups (6.3 ± 2.7 for the coaptation splint group vs. 5.8 ± 3.1 for the Sarmiento brace group, P = 0.520). CONCLUSIONS:Immediate Sarmiento bracing was associated with increased patient-reported pain (roughly 1 point on the 0-10 numeric rating scale) and higher skin complication rates during the initial 10-day period after injury compared with initial coaptation splinting for acute humeral shaft fractures, without demonstrable benefits in function, analgesic requirements, or patient satisfaction. These findings support the traditional approach of initial coaptation splinting followed by delayed transition to functional bracing once acute swelling subsides. LEVEL OF EVIDENCE/METHODS:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
PMID: 42466769
ISSN: 1531-2291
CID: 6067322
Ankle Syndesmotic Injury With Posterior Tibial Tendon Rupture [Case Report]
Lezak, Bradley A; Mercer, Nathaniel P; Lowe, Dylan T; Egol, Kenneth A
Isolated ankle syndesmotic injuries are uncommon and are typically discussed in the context of athletic high ankle sprains; however, concomitant rupture of the posterior tibial tendon represents an exceedingly rare injury pattern. This case highlights the importance of maintaining a high index of suspicion for associated soft-tissue pathology in patients presenting with syndesmotic instability in the absence of fracture. This case underscores the need for comprehensive clinical and imaging evaluation of isolated syndesmotic injuries and supports primary tendon repair when rupture is identified.
PMID: 42466780
ISSN: 1531-2291
CID: 6067372
AC Joint Reconstruction Using Cortical Suture Button and Semitendinosus Allograft
Egol, Alexander J; Lowe, Dylan T; Egol, Kenneth A
Acromioclavicular joint injury reconstructive options include a wide number of described techniques. Although no single technique has consistently demonstrated superior clinical outcomes in the literature, there are theoretical biomechanical benefits to a combined reconstructive technique using cortical suture button and semitendinosus allograft. This review describes an acromioclavicular joint reconstruction using a cortical suture button and semitendinosus allograft.
PMID: 42466771
ISSN: 1531-2291
CID: 6067332
Integration of arterial and angiosome injury into computed tomography (CT) soft-tissue zone of injury models for open OTA 42A-C tibia fractures
Goldstein, Amelia R; Vu, Natalie; Ganta, Abhishek; Egol, Kenneth A; Konda, Sanjit R
PURPOSE/OBJECTIVE:To evaluate whether incorporation of arterial injury into CT-based zone-of-injury (ZOI) models improves complication prediction after open tibial shaft fractures. METHODS:A retrospective cohort study was conducted at an urban multicenter academic hospital (2012-2024). Patients ≥ 18 years with open OTA 42A-C tibia fractures, preoperative CT, and ≥ 6 months follow-up were included. Arterial injury and wound location within the anterior tibial, posterior tibial, or peroneal angiosomes were identified on CT angiography. Soft-tissue ZOI (longitudinal extent of soft-tissue air) and fracture ZOI (fracture span) were normalized to tibial length. The primary outcome was a composite complication of fracture-related infection, nonunion, or amputation. Logistic regression identified predictors, and ROC analysis compared discrimination of (1) an angiosome-augmented ZOI model, (2) a standard ZOI model, and (3) Gustilo-Anderson classification. RESULTS:Eighty-two patients were included: 32 (39.0%) developed major complications. Arterial injury was present in 11 patients and significantly associated with complications (72.7% vs 33.8%, p = 0.020). The augmented ZOI model included arterial injury, anterior angiosome involvement, number of angiosomes affected, normalized soft-tissue ZOI, and BMI (AUROC 0.777), outperforming the standard ZOI model (AUROC 0.707) and Gustilo-Anderson classification (AUROC 0.592). DeLong testing showed no significant difference between ZOI and the augmented model. CONCLUSION/CONCLUSIONS:The original CT-based ZOI model, which incorporates soft-tissue injury measurements normalized to tibial length and BMI, remains a robust objective predictor of complications following open tibial shaft fractures, consistent with prior published work. While arterial injury is associated with adverse outcomes, its addition to ZOI-based models does not significantly improve predictive performance. Notably, only the arterial-augmented ZOI model demonstrated a statistically significant improvement in discrimination over the Gustilo-Anderson classification, whereas the standard ZOI model did not reach significance in this cohort, suggesting that augmentation may be necessary to meaningfully surpass subjective wound grading. LEVEL OF EVIDENCE/METHODS:III.
PMID: 42400670
ISSN: 1432-1068
CID: 6063962
Dementia as a Marker of Poor Outcome After Hip Hemiarthroplasty
Vu, Natalie H; Olson, Danielle; Hammond, Benjamin; Egol, Kenneth A; Konda, Sanjit R; Ganta, Abhishek
PURPOSE/OBJECTIVE:To evaluate the effect of baseline dementia on postoperative outcomes in hip fracture patients undergoing hemiarthroplasty. METHODS:A retrospective review was conducted of patients aged 55 years or older who underwent hemiarthroplasty for displaced femoral neck fracture (AO/OTA 31B) between 2012 and 2024 at a large urban academic institution. Dementia was identified by ICD-10 codes and confirmed by chart review. A 3:1 propensity score matched cohort was created using the Score for Trauma Triage in Geriatric and Middle-aged (STTGMA). Demographics and baseline characteristics were compared to ensure similarity. Outcomes included total complications, major and minor complications, periprosthetic dislocation, length of stay, ICU admission, discharge location, 30- and 90-day readmission, revision surgery, inpatient, and 30-day and 1-year mortality. RESULTS:A total of 1,030 patients were included, with 241 patients with dementia and 839 controls. After 3:1 STTGMA propensity matching, baseline characteristics were comparable (mean age 82.75 vs. 83.0 years, P = 0.065; Charlson Comorbidity Index 1.96 vs. 1.92, P = 0.42; STTGMA 0.022 vs. 0.020, P = 0.50). Patients with dementia had increased major complications (17.92% vs. 10.93%, P = 0.013), including sepsis (5.00% vs. 2.21%, P = 0.027), urinary tract infections (13.33% vs. 6.78%, P = 0.002), and hip hemiarthroplasty dislocations (6.25% vs. 2.21%, P = 0.002). Patients with dementia also had longer length of stay (7.84 ± 5.83 vs. 6.80 ± 2.24 days, P = 0.030), increased 30-day readmissions (15.83% vs. 8.85%, P < 0.001), increased 90-day readmission (20.00% vs. 11.76%, P < 0.001), and higher 1-year mortality (16.25% vs. 8.02%, P < 0.001). No differences were observed in pneumonia, stroke, myocardial infarction, cardiac arrest, venothromboembolism, acute kidney injury, anemia, and revision surgery. CONCLUSION/CONCLUSIONS:Dementia was associated with increased major complications, hip hemiarthroplasty dislocations, higher readmission, and mortality after hemiarthroplasty. These findings highlight the need for targeted perioperative planning and multidisciplinary care pathways in cognitively impaired patients.
PMID: 42377450
ISSN: 1940-5480
CID: 6062592
Tourniquet Use Does Not Affect Soft Tissue Outcomes Following Rotational Ankle Fracture Repair
Xie, Justin F; Ganta, Abhishek; Tejwani, Nirmal; Konda, Sanjit R; Egol, Kenneth A
IntroductionTourniquet use for ankle fracture fixation surgery is a common but not universally accepted practice due to concerns regarding soft tissue complications. Although prior literature has demonstrated increased short-term postoperative pain, tourniquet use's association with other complications remains under-investigated.MethodsA retrospective cohort study was performed of adult patients undergoing open reduction and internal fixation of a closed rotational ankle fracture (OTA Type 44) between 2012 and 2024 at an urban academic health system. Patients were stratified by tourniquet use. Demographic information, injury characteristics, and operative variables were collected. The primary outcome was the development of postoperative complications-wound dehiscence, fracture-related infection, superficial wound infection, delayed wound healing, peripheral nerve injury, venous thromboembolism, and nonunion. Secondary outcomes were operative time and estimated blood loss. Multivariable logistic regression was used to evaluate the association between tourniquet use and postoperative complications.ResultsA total of 617 patients met the inclusion criteria, including 446 who had a tourniquet inflated during surgery and 171 who did not. No significant differences in baseline patient demographics or comorbidity were observed. After multivariable logistic regression, tourniquet use was not associated with higher odds of any wound complication, fracture-related infection, delayed wound healing, or peripheral nerve injury. Among patients in the tourniquet cohort, 4 developed venous thromboembolism and 7 developed a fracture nonunion. No such complications were observed among patients treated without a tourniquet. Tourniquet use was associated with a modest decrease in estimated blood loss (47.3 ± 44.2 vs 33.9 ± 36.0 mL, P < .001) with no significant increase in operative time.ConclusionTourniquet use during operative fixation of closed rotational ankle fractures was not associated with increased soft tissue or bony complications. The findings support the safety of continued tourniquet use per surgeon preference, provided that appropriate patient selection is employed.
PMID: 42400414
ISSN: 1938-7636
CID: 6063942