Adverse events related to total ankle replacement devices: an analysis of reports to the United States Food and Drug Administration.

BACKGROUND: The published outcomes of total ankle replacement (TAR) implants came from limited institutions creating observational bias. For broader perspective, we queried the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) voluntary database to explore complications reported outside published literature. METHODS: The database was reviewed retrospectively between November 2011 and April 2019 using two product codes assigned to six TAR devices. RESULTS: Among 648 relevant reports available in the database, common complications were aseptic loosening (19.3%), infection (18.2%), and alignment/mechanical issues (16.5%). Others included instrument/instrumentation complications, impingement, polyethylene problems, fractures, avascular necrosis of talus (AVN), and packaging issues. CONCLUSION: MAUDE database revealed various patterns of device-related malfunctions that have been under-reported in published data. Despite inconsistency in the available reports, it provided opportunities for improvements in quality control, device design, and ultimately patient safety. Database would be further strengthened by more robust reporting mechanism or mandatory reporting of device-related complications.

A cadaveric comparison of two methods for isolated talonavicular arthrodesis: Two-screws versus plate with integrated compression screw.

BACKGROUND: This study compared stiffness between two constructs for talonavicular arthrodesis: a dorsomedial plating system and two partially threaded cannulated cancellous screws. We hypothesized that the plate would exhibit greater stiffness and resistance to deformation during cyclic loading. METHODS: The constructs were implanted in eight matched pairs of cadaveric feet and subjected to axial torsion, cantilever bending in two directions, and cyclic loading to failure. RESULTS: The two-screw constructs were significantly stiffer in plantar-dorsal bending (p = .025) and trended towards a higher number of cycles before failure than the plate group (p = .087). No significant differences were observed in internal torsion (p = .620), external torsion (p = .165), or medial-lateral bending (p = .686). CONCLUSIONS: This study provided the first biomechanical assessment of a plating system with an integrated compression screw, which was significantly less stiff than a two-screw construct when loaded from plantar to dorsal.

Comparative study of autograft harvested from contra lateral proximal tibia versus the iliac crest for operative management of depressed tibial plateau fractures.

Our study evaluates differences in fracture healing, clinical outcome and donor site morbidity between iliac crest bone graft and contra lateral proximal tibial bone graft utilized for internal fixation of displaced tibial plateau fractures. In 34 patients requiring bone grafting, iliac crest was utilized in 16 cases and proximal tibia in the remaining 18. Fracture union was achieved in all patients in either group at a mean period of 14 weeks with no difference in the functional knee scores between the groups. The iliac crest group showed significantly higher visual analogue pain scores in the immediate post-operative period and greater donor site complications like superficial wound infection, incisional hernia and chronic pain compared to the proximal tibial group. Contra lateral proximal tibia offers a viable alternative to iliac crest as a donor site for bone graft with adequacy of graft quantity, ease of graft harvest and lesser donor site morbidity.

Missed peroneus longus tendon laceration following plate-glass injury: A pitfall in the emergency department.

A thorough exploration of traumatic wound is critical to accurately assess the severity of the injury. When it comes to glass-related injuries, the diagnosis of a glass foreign body is often prioritized over identifying any underlying damage. The authors report a case of peroneus longus tendon rupture caused by plate-glass accident that was misdiagnosed in the emergency department (ED) as a superficial laceration.

Isolated lateral-sided knee pain in total knee arthroplasty. A review.

Isolated lateral-sided knee pain is a unique problem following total knee arthroplasty (TKA). Reported causes include soft tissue impingement against extruded cement, an overhanging tibial tray, remnant osteophytes rubbing against the iliotibial band (ITB), popliteal tendon impingement, fabella syndrome, and synovial tissue impingement in the lateral gutter. In addition, iliotibial band traction syndrome secondary to guided motion Bi-cruciate stabilizing knee arthroplasty has been recognized as a new clinical entity. Initial work up should include ruling out the most common causes of painful TKA including infection, aseptic loosening, and instability. Radiographs and CT scan are utilized to identify potential source of pain. Ultrasound evaluation (with elicited probe tenderness) can increase diagnostic accuracy. Ultrasound guided local anesthetic injections can confirm the source of pain. Anti-inflammatory medications, physical therapy with ITB stretches, and therapeutic local steroid injections are initial treatment modalities. Satisfactory resolution of symptoms may require surgical intervention directed at the specific cause and may avoid the morbidity associated with revision TKA.

Delayed Presentation of Displaced Salter-Harris III Distal Tibia Fracture: Does Transfracture Reduction Yield Satisfactory Outcomes?

LEVELS OF EVIDENCE: Level V.

A Novel Positioning Technique for Olecranon Fracture Fixation.

Various positioning techniques have been described for the osteosynthesis of olecranon fractures, each with their own pros and cons. The supine position is time-efficient and better suited in a polytrauma setting but frequently requires an assistant to maintain optimal limb positioning. Also, adequate fluoroscopic imaging is not possible without moving the operative extremity outside the sterile field. We describe a simple and reproducible method addressing these limitations while providing excellent surgical access and intraoperative imaging.

A simple tool for volar tilt restoration during volar plate osteosynthesis of distal radius fracture: A technical note.

Anatomical restoration of volar tilt is a technical challenge in a displaced distal radius fracture with a dorsally angulated fracture pattern accompanied by dorsal metaphyseal comminution. We adopted a reduction technique using a mini-Hohmann retractor, to accomplish the desired volar tilt in a controlled fashion. We would like to present this technical note through a case example describing the technique specifics along with one-year postoperative outcomes.

Total Hip Arthroplasty in Cirrhosis is Associated with Increased Complications during the Hospital Stay, Length of Stay, and Cost of Care: A Propensity Matched Database Study.

Objectives: The aim of the study is to evaluate the impact of cirrhosis on inpatient hospital complications and healthcare costs in elective Total Hip Arthroplasty (THA). Methods: A 4-year retrospective analysis of the Nation Inpatient Sample (NIS) database, who underwent elective THA stratified by the presence or absence of cirrhosis was performed (2016-19). The records of specific postoperative complications, the cost of care (COC), and the length of stay (LOS) were evaluated by statistical analysis. Results: The NIS database identified 367,894 patients who underwent THA, of which 1,134 (0.3%) were cirrhotic. In the unmatched analysis, patients with cirrhosis showed significantly elevated rates (P< 0.05) of in-hospital complications compared to non-cirrhotic controls, including mortality (0.7% vs. 0.1%), acute renal failure (9.2% vs. 2.5%), blood loss anemia (30.4% vs. 19.5%), pneumonia (1.1% vs. 0.3%), periprosthetic fracture (3% vs. 1.2%), dislocations (2.5% vs. 1.4%), infection (4.2% vs. 1%), wound dehiscence (0.8% vs. 0.1%) and blood transfusion (11.3% vs. 3.5%). After propensity matching, significantly higher rates of blood loss anemia (30.4% vs. 26.7%; P=0.05), periprosthetic dislocations (2.4% vs. 1%; P=0.008), and infections (4.2% vs. 2.7%, P=0.05) were seen in the cirrhotic cohort, while the rate of pulmonary embolism was significantly lower (0% vs. 0.8%, P=0.002), as was myocardial infarction (0.08% vs. 0.7%, P=0.017). Concerning LOS in the hospital, patients with cirrhosis stayed significantly longer in both the unmatched (4.2 vs. 2.3 days; P <0.001) and matched (4.2 vs. 3.68; P=0.016) controls. The average COC was greater in the cirrhotic group, with a mean value of $90,264 vs. $66,806.31 (P<0.001) in the unmatched and $90,624 vs. $80,676.87 (P=0.001) in the matched cohort. Conclusion: Cirrhosis is associated with longer lengths of stay, higher hospital costs, and a greater risk of perioperative in-hospital complications such as blood loss anemia, dislocation, and infection after THA. This data could assist during preoperative patient counseling and improve the strategies for effectively utilizing the finite healthcare resources without compromising patient care and financial compensation from payers.

Intraoperative Ultrasound for Extracting Deep-Seated Radio-Opaque Foreign Body from Calf: A Case Report.

CASE: A 50-year-old man presented with chronic refractory symptoms of radiating leg pain with muscle cramps because of a retained bullet in the calf after being shot in 1990. Radiographs confirmed the bullet lodged in posterolateral aspect of calf abutting proximal fibula. An intraoperative point-of-care ultrasound aided in accurate localization of bullet, thereby facilitating precise planning of surgical incision and subsequent removal. CONCLUSIONS: Ultrasound can be used as an alternative tool for safe surgical extraction of deep-seated metallic object with minimal tissue dissection, obviating the need for C-arm.

Patients With Cirrhosis Have Higher Costs of Care, Longer Length of Stays, and More Perioperative Complications Following Total Knee Arthroplasty: A National Inpatient Sample-Based Study.

Background Cirrhosis is a growing disease affecting millions of people in the United States annually. Many cirrhosis patients undergo significant procedures and are met with increased risks such as encephalopathy, impaired immune response, ascites, variceal bleeding, renal disease, and increased malnutrition. Many cirrhosis patients need to undergo major surgical procedures such as total knee arthroplasty (TKA); however, perioperative complications following TKA in cirrhosis patients have not been studied. The purpose of this study was to analyze the demographic characteristics and perioperative complications of cirrhosis patients following TKA. Methods Using the National Inpatient Sample (NIS) database, we looked at retrospective data from the years 2016-2019 to analyze the incidence of perioperative complications, length of stay (LOS), and the cost of care (COC) among patients undergoing TKA who were categorized as cirrhosis patients, compared with those who are not. A propensity match was conducted to consider associated comorbidities that influence perioperative complications. Results Of the 558,256 patients analyzed who underwent TKA, 1670 (0.3%) were diagnosed with cirrhosis. After matching, cirrhosis patients had a longer LOS (4.22 vs. 3.68 days, p=0.016) and COC ($90,624 vs. 80676.87, p<0.001) than patients in the control group. Moreover, cirrhosis patients had a higher likelihood of developing acute renal failure (odds ratio (OR): 3.05, 95% CI: 2.07-4.50, p<0.001), blood loss anemia (OR: 1.60, 95% CI: 1.34-1.92, p<0.001), periprosthetic fracture (OR: 3.27, 95% CI: 1.31-8.18, p=0.007), periprosthetic infection (OR: 3.14, 95% CI: 1.99-4.95, p<0.001), and blood transfusions (OR: 1.62, 95% CI: 1.12-2.35, p=0.009) than patients in the control group. Conclusion The cirrhosis group had a significantly higher COC, longer LOS, and higher rates of perioperative complications than non-cirrhosis patients. This data will help providers make informed decisions about patient care and resource allocation for cirrhosis patients undergoing TKA.

Using Biceps Tendon Autograft as a Patch in the Treatment of Massive Irreparable Rotator Cuff Tears Improves Patient-reported Outcome Scores: A Systematic Review.

Purpose: To review the clinical studies describing the use of ipsilateral biceps tendon autograft for bridging irreparable massive rotator cuff tears (MRCTs). Methods: A systematic review was conducted of MEDLINE, Embase, Cochrane, CINAHL, and Scopus databases using search terms "massive rotator cuff tear," "irreparable rotator cuff tear," and "long head of the biceps tendon." Only clinical human studies in which the biceps tendon was used as a bridging graft in MRCTs were included. All review studies, technique papers, and studies describing the use of biceps tendon as superior capsular reconstruction equivalent or rotator cable were excluded. Results: A total of 45 studies were initially identified, of which only 6 studies met the inclusion criterion. All studies were retrospective in nature, with a total of 176 patients. All studies reported a clinically significant improvement in postoperative functional outcomes, although this was not compared to a control group in all the studies. Pain was assessed using the visual analog scale (VAS) in 4 studies, and all reported an improvement in postoperative VAS ranging from 5 to 6 points. One study reported an improvement in pain scale from Japanese Orthopedic Association from 13.1 to 22.5 (9 points). One study did not report a VAS score as this study was published before the VAS score was developed. All the reported studies saw improvements in range of motion. Conclusions: The use of the long head of the biceps tendon as an interposition/bridging patch to augment the MRCT repair can reduce the VAS score, improve elevation and external rotation, and improve clinical and functional outcomes. Level of Evidence: IV, systematic review of Level III and IV studies.

Endoscopic Sciatic Neurolysis for Deep Gluteal Syndrome: A Systematic Review.

Deep gluteal syndrome (DGS) is an underdiagnosed condition caused by an extra-spinal entrapment of the sciatic nerve in the deep gluteal space. Symptomatic patients who fail conservative treatment require surgical decompression of the nerve either by an open or endoscopic approach. In recent times, there has been an increasing trend towards minimally invasive surgery performed with endoscopic techniques. This systematic review aimed to assess the effectiveness of endoscopic sciatic nerve decompression in the management of DGS. A comprehensive search of the PubMed, Web of Science, Cumulated Index to Nursing and Allied Health Literature (CINAHL), and SPORTDiscus databases were performed on January 3, 2022. All English-language clinical studies on DGS treated with endoscopic surgical decompression were included. The initial search criteria identified 145 articles, of which four studies were available for the final review. There was one level III evidence, while the remaining three were level IV, comprising 144 patients with a mean age of 46 years. The Coleman methodology score (CMS) was utilized to assess the quality of the studies and the mean score was 62 (range, 52 to 71). The presence of fibrovascular bands and bursal tissue was the most common cause of DGS, followed by musculotendinous structures. The average follow-up of the included studies was 26.3 months (range, 12 to 32 months). Less favorable outcomes were seen in patients with major traumatic sciatic neuropathies after fractures or open reconstructive hip surgeries. Conversion to formal open surgery was recorded in one case of DGS caused by sciatic nerve schwannoma due to poor endoscopic access. One patient developed postoperative recurrent sciatic nerve entrapment due to a foreign body reaction requiring an open decompression. Overall, the available studies reported a high degree of clinical success with a low rate of complications, albeit no high-quality studies could be identified.

Staged Achilles Allograft Reconstruction of Chronic Bilateral Simultaneous Tears of the Retracted Distal Biceps Tendon Using a Novel Fixation Technique.

Bilateral simultaneous rupture of distal biceps tendons is an extremely rare clinical entity that can result in significant morbidity for an active person if not addressed appropriately. Treatment becomes more complicated in a delayed presentation as the tendon retracts and scars to the adjacent tissues, thus precluding a primary tendon-to-bone repair. The present study is a case report of an active male with a two-month-old simultaneous rupture of both distal biceps tendons managed by Achilles allograft reconstruction and double cortical-button fixation technique that provided a satisfactory functional outcome.

Failure of Primary Distal Biceps Repair After Cortical Button Fixation With Whipstitch Technique: A Root Cause Analysis.

Rerupture after cortical button fixation and whipstitch suture technique is a rare complication of distal biceps tendon repair. The tendon-bone fixation construct can fail for various reasons, including cortical breach, pull out or disengagement of a cortical button, suture breakage, or knot slippage. Occasionally, a cut-through of the tendon substance by the high-tensile strength suture material, called the 'cheese-wire' effect, can happen, especially with premature loading during the early postoperative period. The clinical presentation is more subtle, and the rerupture may go unnoticed. A high index of suspicion and a low threshold for ordering a magnetic resonance imaging (MRI) scan are necessary for a prompt diagnosis and early treatment. We describe the management of a reruptured distal biceps in an active male that happened in the early postoperative period, along with a critical analysis of the failure pattern and potential preventive measures.

Salvage of Hindfoot Charcot with Osteomyelitis and Ulceration: A Case Report.

Diabetic Charcot arthropathy of the ankle, due to the presence of multiplanar deformities, and associated medical comorbidities, poses a challenge for treating physicians. The situation becomes more complicated when accompanied by ulceration and osteomyelitis, leaving limited salvage options. We present a case of advanced Charcot ankle arthropathy with osteomyelitis and ulcerated hindfoot. It was managed by talectomy and antibiotic-impregnated cement beads, followed by hindfoot arthrodesis using a retrograde intramedullary nail six weeks later. This two-stage reconstruction approach resulted in an ulcer-free, stable, plantigrade foot at one-year postoperative follow-up.

Association Between Self-Reported Kinesiophobia and Single-Leg Hop for Distance in Patients With ACL Reconstruction: A Systematic Review.

CONTEXT: Psychological readiness is a significant factor in determining successful return to sport (RTS) and physical activities after anterior cruciate ligament (ACL) reconstruction. Knowing the influence of kinesiophobia on physical tests that are used to guide RTS, such as the single-leg hop for distance (SLHD), would contribute to advancing clinical practice. OBJECTIVE: To investigate the association between kinesiophobia and SLHD performance in patients after ACL reconstruction. DATA SOURCES: A comprehensive search strategy entailed surveying 6 databases for relevant articles published from January 2009 to March 2021. STUDY SELECTION: Articles published in English that were a minimum of level 3 evidence describing kinesiophobia, as measured by the Tampa Scale for Kinesiophobia, and related to SLHD performance in patients after ACL reconstruction. STUDY DESIGN: Systematic review. LEVEL OF EVIDENCE: Level 3. DATA EXTRACTION: Study characteristics, sample population demographics, instrument(s), or approach(s) used to assess kinesiophobia and SLHD performance, and corresponding results. RESULTS: A total of 152 potential studies were identified, 106 studies underwent screening, 40 were reviewed in full, and 7 studies were included. Meta-analysis could not be performed because of differences in experimental design among studies and instances of missing outcome data. Currently, moderate evidence indicates patients with ACL reconstruction that exhibit less kinesiophobia perform better on the SLHD test. CONCLUSION: The outcomes of this review propose that sports health practitioners consider the influence of kinesiophobia on SLHD performance as a criterion for RTS and physical activities in patients after ACL reconstruction. Higher quality studies are necessary to establish the extent of association between these variables.

Adverse Events Related to Cartiva Hemiarthroplasty of First Metatarsal: An Analysis of Reports to the United States Food and Drug Administration.

Background: The results supporting Cartiva, a synthetic cartilage implant (Wright Medical) in hallux rigidus have come from limited institutions creating observational bias. Complications experienced in community centers are not routinely included in the published literature. To look at a broader range of potential complications, we reviewed the United States Food and Drug Administration's (FDA) voluntary device database and compared that data with published literature. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database of the FDA was retrospectively reviewed between July 2016 and October 2019 using the product code: PNW, assigned for Cartiva. Results: A total of 49 events have been reported and implant subsidence was the most common with 16 reports. Others include fragmentation (9), infection (4), bone erosion (3), foreign body reaction (1) and unspecified (16). Thirty-five events mentioned further surgeries at a mean interval of 4.75 months. Conclusions: The analysis of the MAUDE database disclosed certain device-related dysfunctions that have been underreported in the published literature. Because of the voluntary nature of reporting, the true incidence of each complication is unknown with this data representing a baseline. The MAUDE database could be further strengthened by a more robust reporting mechanism or mandatory reporting of device-related complications.Levels of Evidence: Level IV: Case series from large database analysis.

Superior Capsular Reconstruction Using the Biceps Tendon in the Treatment of Irreparable Massive Rotator Cuff Tears Improves Patient-Reported Outcome Scores: A Systematic Review.

Purpose: To systematically evaluate the clinical outcomes of superior capsular reconstruction (SCR) using the long head of the biceps tendon for irreparable massive rotator cuff tears. Methods: Multiple electronic databases were searched for studies treating massive and/or irreparable rotator cuff tears with SCR using the biceps tendon while retaining its proximal attachment to the superior glenoid. A PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) flowchart was created. All the included studies were assessed for quality with the Modified Coleman Methodology Score. Multiple variables including patient demographic characteristics, functional scores, visual analog scale (VAS) scores, and complications were extracted and analyzed. Results: Seven studies were included in this review, with a total of 133 patients. The age range of patients was 39 to 82 years, and the duration of follow-up ranged from 6 to 40.7 months. Various validated scoring systems were used for functional outcome evaluation in all studies; all of them showed postoperative improvement greater than the minimal clinically important difference. The VAS score improvement ranged from 3.8 to 7.1. Five studies reported improvement in shoulder forward elevation, with a range of 22° to 95°. Three studies reported retear rates of 21%, 37%, and 66% on postoperative magnetic resonance imaging scans. Two studies reported complications, with the first study reporting revision surgery in 4 of 35 patients and the second study reporting 1 infection and 1 case of deltoid detachment (open procedure) among 17 patients. Conclusions: SCR using the long head of the biceps tendon is a safe and effective procedure. VAS and patient-reported outcome scores showed significant improvement with minimal short-term complications. Level of Evidence: Level IV, systematic review of Level III and IV studies.

Olecranon Fracture in an Older Adult Treated With Locking Plate Osteosynthesis.

Although olecranon fractures are not uncommon in the geriatric population, there has been a considerable difference of opinion between surgical and nonsurgical treatments. Surgical treatment is usually deferred in the elderly, even for displaced olecranon fractures, because of inherent risks associated with poor bone quality and soft tissues, which often necessitate further surgeries. However, nonoperative treatment frequently results in an inability to regain full extension strength of the elbow, which can be disabling in select older adults with higher functional demands. We present an active older adult with a displaced olecranon fracture, who achieved a satisfactory result after open reduction and internal fixation (ORIF) using a low-profile locking plate.