Florida Orthopaedic Institute

Spinal surgeries have become common procedures due to greater life expectancy and the increasing elderly population. Failed fusion, or nonunion, may be influenced by patient risk factors and can lead to a myriad of complications. Pulsed electromagnetic field (PEMF) stimulation is a noninvasive post-operative adjunct therapy that has been shown to influence underlying cellular processes that may improve osteogenesis to promote successful fusion following spinal surgery. The aim of the study was to evaluate the effect of PEMF on lumbar fusion in patients with risk factors for nonunion. The current study employed a prospective, multicenter study to investigate PEMF as an adjunct therapy following lumbar spinal fusion procedures in subjects with risk factors for failed fusion. A retrospective control arm was used as a comparator. Subjects were enrolled with at least one of the following risk factors: prior failed fusion, multi-level fusion, nicotine use, osteoporosis, advanced age (>65 years), body mass index >30 kg/m2, and diabetes. PEMF was delivered for 6-months following surgery. Overall fusion status and influence of risk factors were assessed. Successful fusion was determined by radiographic imaging. Fusion status was compared at a 12-month follow-up in subjects treated with PEMF (n=142) vs. control (n=47). Successful fusion was observed in 88.0% (n=125/142) of PEMF subjects and 68.1% (n=32/47) of control subjects. PEMF therapy resulted in statistically improved fusion rates in subjects with prior failed fusion (P=0.04), multi-level fusion surgery (P<0.001), and advanced age (P<0.001) when compared to control. PEMF therapy resulted in statistically improved fusion rates in subjects who had at least one risk factor (P=0.002), ≥2 risk factors (P<0.001), and ≥3 risk factors (P=0.003) compared to control. Linear regression analyses showed a significant treatment effect of PEMF across all risk factors and presentations (P=0.003). A favorable safety profile was observed with PEMF therapy. PEMF therapy improved fusion success in subjects following lumbar spinal surgery and represents a beneficial adjunct treatment resulting in significant improvements in subjects having risk factors for nonunion.

Revision or secondary rhinoplasty involving the nasal tip is challenging due to distorted anatomy, scarring, and compromised tip support. This article presents a framework for surgical approach and decision-making in secondary rhinoplasty. Contemporary principles emphasize stability, conservative cartilage handling, and restoring native architecture. The nasal tip depends on the soft-tissue envelope and lower lateral crura, whose relationship with the septum determines projection, rotation, and contour. High-resolution photography, endoscopy, and improved grafting materials enhance the diagnosis and correction of nasal tip deformities. Optimal patients should undergo in-depth assessment with special attention to skin thickness, previous complications, and unrealistic expectations. Structure and support of the tip cartilages are the foundation and critical for the appearance and longevity of your results. As part of building the structure and support, the lower lateral cartilages can be repositioned and reshaped to the ideal appearance. Further refining of the definition and contour then occurs, with management of the soft tissue envelope being part of the decision process throughout. Scar modulation and protection of graft constructs are critical for long-term stability. Regenerative therapies, advanced biomaterials, and minimally invasive contour solutions continue to evolve. A regimented, anatomy-driven approach provides consistent and durable outcomes in revision tip rhinoplasty.

BackgroundPeripheral nerve injuries can result in severe and lasting morbidity, including motor weakness, pain, and functional deficits, even with timely intervention. Treatment options include non-operative management and surgical interventions, such as direct end-to-end nerve repair for low-tension injuries or grafting techniques (e.g., autograft, allograft, and tissue-engineered grafts) for large-gap injuries. Recent research has focused on the regenerative potential of human amniotic fluid stem cells (AFS) due to their paracrine effects. Amniotic fluid stem cell-conditioned media (AFS-CM) has emerged as a promising therapeutic adjunct, offering ease of formulation and low immunogenicity. However, the role of AFS-CM in peripheral nerve repair remains poorly understood. This study investigates the effects of AFS-CM on peripheral nerve recovery in a sciatic nerve injury model in CD1 mice.MethodsThirty-six male CD1 mice underwent sciatic nerve transection of the left hindlimb and were divided into three groups: (I) control group—direct end-to-end nerve repair; (II) hydrogel group—reconstruction with a hydrogel-coated silicone graft; and (III) AFS-CM group—reconstruction with an AFS-CM-infused hydrogel-coated silicone graft. Post-surgical treatments were administered biweekly via hydrogel (control and hydrogel groups) or hydrogel plus AFS-CM (AFS-CM group). Functional recovery was assessed through gait analysis, electromyography (EMG), and nerve conduction studies at two weeks, one month, and two months. Muscle and nerve tissues were analyzed using immunohistochemistry. Statistical analyses included analysis of variance (ANOVA) and generalized linear models, with a significance threshold of P<0.05.ResultsNo significant differences were observed in EMG amplitude and latency or the G-ratio across all groups (P>0.05). Gait analysis revealed substantial improvements in overlap distance (P<0.001) and ataxia coefficient (P=0.01) in the AFS-CM group compared to the hydrogel group. The AFS-CM group also demonstrated reduced expression of muscle RING-finger protein-1 (MURF-1), indicative of less muscle atrophy, and increased expression of alpha-bungarotoxin, suggesting improved neuromuscular junction (NMJ) recovery. Among the groups, no significant differences were noted in malondialdehyde expression, a marker of oxidative stress.ConclusionsAFS-CM shows promise as a therapeutic adjunct in peripheral nerve repair, improving functional outcomes and reducing muscle atrophy compared to hydrogel-only reconstruction. While electrophysiological and morphological outcomes showed no significant differences, the enhanced gait performance and NMJ recovery observed in the AFS-CM group highlight its regenerative potential. Further studies are warranted to elucidate the underlying mechanisms and to optimize the clinical application of AFS-CM in peripheral nerve injury management.

Prospective, multicenter, single-blind, randomized, controlled pivotal study. To evaluate whether P-15L (PearlMatrix P-15 Peptide Enhanced Bone Graft) is noninferior in effectiveness to local autograft when applied in single-level instrumented transforaminal lumbar interbody fusion (TLIF). P-15L, an FDA-designated Breakthrough Drug-Device, is a composite drug-device combination bone graft containing P-15, a 15-amino acid polypeptide, which enhances cell binding, proliferation, and differentiation, resulting in bone formation. Skeletally mature patients, aged 22 to 80 years, with degenerative disc disease (DDD) were randomized 1:1 to P-15L (investigational) or to the local autograft (control) during single-level TLIF with a polyetheretherketone (PEEK) cage and supplemental pedicle screw fixation. The primary outcome was composite clinical success (CCS) at 24 months, defined as: no index level secondary surgical procedures; achievement of fusion; ≥15-point improvement in Oswestry low back pain disability questionnaire (ODI) from baseline; no new or worsening persistent neurological deficit relative to baseline; and no device-related serious adverse events (SAEs). A total of 290 patients were enrolled at 33 sites: 141 (48.6%) received P-15L, and 149 (51.3%) received local autograft. P-15L was noninferior ( P <0.0001) and superior ( P =0.002) to autograft with respect to CCS, with 55.5% of the investigational group achieving composite clinical success compared with 37.5% of the control group. P-15L had a 25.8% higher fusion rate as compared with autograft for the CCS at 24 months (84.3% vs. 58.5%, respectively). Device-related SAE rates were similar in both groups. P-15L was superior to local autograft in achieving clinical success at 24 months. Furthermore, P-15L produced a significantly higher fusion rate as compared with autograft. No meaningful clinical differences were found in the incidence of device-related SAEs. P-15L appears to be a safe and effective option for TLIF. Level I.

Study Design.Prospective, multicenter, single-blind, randomized, and controlled pivotal study.Objective.Compare time-to-fusion in patients treated with P-15L (PearlMatrixTM P-15 peptide enhanced bone graft) versus local autograft over 24 months and evaluate changes in pain and quality of life at 24 months relative to baseline.Summary of Background Data.P-15L, an FDA-designated breakthrough device, is a composite bone graft with P-15, a 15-amino acid polypeptide that promotes cellular adhesion, proliferation, and differentiation to support bone formation.Methods.Patients (22–80 y) with degenerative disc disease were randomized to the investigational (P-15L) or control (local autograft) group during single-level transforaminal lumbar interbody fusion (TLIF) with a PEEK cage and supplemental pedicle screw fixation. Fusion assessments occurred at 6, 12, and 24 months. Time-to-fusion was tested for superiority as compared with the control using Kaplan-Meier survival analysis. Back and leg pain were measured using the Visual Analog Scale (VAS) and quality of life was assessed using the Short Form Survey (SF-12).Results.The analysis included 290 patients from 33 sites; 141 (48.6%) received P-15L and 149 (51.3%) received local autograft. At randomization, at least one risk factor for pseudoarthrosis (obesity, nicotine use, or diabetes) was reported in 58.9% (83/141) of the investigational group and 60.4% (90/149) of the control group. More patients in the investigational group than the control group achieved fusion at 6 months (Kaplan-Meier fusion rates 57.6% vs. 26.9%, respectively), 12 months (68.8% vs. 41.5%, respectively), and 24 months (81.1% vs. 54.9%, respectively). P-15L was statistically superior to autograft for time-to-fusion (hazard ratio=1.87, 95% CI: 1.47–2.38; P < 0.0001). There was marked improvement in VAS and SF-12 relative to baseline in both groups at 24 months.Conclusion.P-15L promotes statistically superior earlier time-to-fusion than local autograft in instrumented TLIF. Both treatments resulted in clinically meaningful improvements in pain and quality of life at 24 months.Level of Evidence.Level I.

To assess whether patients treated with a Minimally Invasive Rotator-Interval Technique (MIR-IT) versus the traditional technique of splitting the rotator cuff (RTCS) for intramedullary nailing of humeral shaft fractures resulted in comparable post-operative clinical and patient-reported outcomes (PROM). Design: Retrospective Cohort Study. Level 1 Trauma Center. Patients >18yo with humeral shaft fractures (AO/OTA 12A-C) treated with IMN between 2015 and 2022. The primary outcome was differences in PROMs (ASES, Quick DASH, and Oxford Shoulder Score) between the MIR-IT and RTCS techniques. Secondary outcome measures included differences in rates of nonunion, superficial and deep surgical infections, wound dehiscence and iatrogenic nerve palsy between the two techniques. Seventy-one patients underwent humeral IMN (MIR-IT - 39; RTCS - 32). Fifty-five patients (MIR-IT- 30; RTCS-25) had radiographic and clinical follow up to union. Mean follow up was 7.5 months (range: 3.1-16.8 months). Patients did not vary significantly with regards to age (MIR-IT: 54.4 ± 22.4; RTCS: 55.1 ± 18.5 years, p=0.896), and gender (Males- MIR-IT: 46.7%, RTCS: 44%, p=0.843). There were no significant differences in nonunion (7.4% vs 4.0% p=1.0), superficial infection (3.6% vs 4% p=1.0) or iatrogenic nerve palsy (3.6% vs 4.0% p=1.0) between the MIR-IT and RTCS groups. There were no deep infections or wound dehiscences in either group. Forty-two patients had PROMs (MIR-IT -21; RTCS -21). Average time to PROMs collection was 35.7 months (MIR-IT: 34.2 months, RTCS: 37.1 months, p=0.682). There were significantly better ASES scores (82.7 vs 71.6 p=.015), Quick DASH scores (9.7 vs 21.0 p=.011) and Oxford Shoulder Scores (39.3 vs 33.9 p=.042) amongst patients treated with the MIR-IT. Humeral IMN utilizing the MIR-IT resulted in better shoulder PROMs compared to the RTCS technique, with similarly low surgical complication rates. Therapeutic Level II.

To report the incidence of lower leg fasciotomies in tibial shaft and plateau fractures and explore the incidence of potential missed acute compartment syndrome (ACS) with widespread, selective, or no invasive monitoring (IM). This is a retrospective review of adult patients with diaphyseal tibial fractures (Orthopaedic Trauma Association 42A-C), and proximal tibial fractures (Orthopaedic Trauma Association 41A-C) treated surgically at a Level 1 trauma center from 2001 to 2020. Main outcomes of interest include lower extremity fasciotomy rates and incidence of potential missed ACS (abnormal neurovascular examination, sensory changes, chronic pain, claw toes, or amputation) in diaphyseal and proximal tibial fractures at three time intervals: widespread use of IM (w-IM) (2000 to 2010), selective IM (s-IM) (2011 to 2015), and clinical examination with a high index of suspicion alone without IM (CES), 2016 to 2020. Fasciotomy rates decreased from 4.96% (93 in 1,873) in 2001 to 2010 (w-IM) to 2.61% (32 in 1,226) in 2011 to 2015 (s-IM) and to 1.11% (16 in 1,438) in 2016 to 2020 (CES) ( P < 0.001). Random samples of 317 patients with tibial shaft and plateau fractures that did not undergo fasciotomy from 2001 to 2010 (w-IM), 304 patients from 2011 to 2015 (s-IM), and 285 patients from 2016 to 2020 (CES) found that 96.5% had a normal neurovascular examination in the w-IM group, 98.4% in the s-IM group, and 96.8% in the CES group, P = 0.210. No differences were found in sensory changes in the three groups (0.6% for w-IM vs. 1.6% for s-IM vs. 0.4% for CES, P = 0.235) or severe pain (0.6% vs. 0.3% vs. 0.7%, P = 0.589). No patients had late amputation or claw toes in any group. The combined complication rate was slightly lower in the s-IM group (2.0%) and the CES group (2.8%) compared with the w-IM group (4.4%) ( P = 0.214). The rate of fasciotomy for ACS in proximal and diaphyseal tibial fractures has declined over time at our center coinciding with the decreased use of IM with no apparent increase in missed ACS. Diagnostic Level III.

In the United States, cementless fixation is the gold standard for elective total hip arthroplasty (THA). Many modern cementless stem designs have re-introduced collared stem options in recent years which have demonstrated a lower risk of fracture. Minimal studies, however, outline radiographic performance of this novel stem design. As such, the primary purpose of this single-center study was to determine the radiographic performance, including defining patterns of radiographic incorporation and remodeling, associated with this novel, single stem design. Data within the institutional data repository was queried for patients who underwent a primary or conversion THA between January 1st, 2016 and July 31st, 2022. Patients were included in the study if they were 18 years of age or older and had a minimum of a one-year follow-up visit. Patients were excluded if they did not have a radiograph at the one-year follow-up or if the stem was placed in a revision setting. Continuous data were reported as means and standard deviations (± SD), and categorical data were reported as number of cases (n) and percentages (%). A total of 592 encounters (562 patients) were included in the final analyses. At the one-year postoperative visit, no stems met the criteria for radiographic loosening, 502 (85.2%) patients had distinct radiographic osseointegration of their stem as defined by at least one radiographic spot weld. There was an 18.7% incidence of calcar-collar gaps on initial radiographs and 66.7% of these filled in by one-year. The intraoperative fracture rate was 0.7% without any cases of secondary stem revision or loosening and only 0.8% of stems showed subsidence (i.e., all less than 5 mm) without loosening or revision. Thigh pain within the first year was reported in 1.7% of patients. The all-cause stem revision at one-year was 0.2%. This study demonstrated excellent rates of healing of this novel stem design. Additionally, this novel stem was associated with low rates of periprosthetic fracture, stem revision, and thigh pain. Level of Evidence: IV.