Analysis of Complications in Sacroiliac Joint Fusions Using FDA 510(k) Cleared Devices.

STUDY DESIGN: This was a level III-retrospective cohort study. OBJECTIVE: The objective of this study was to present an unbiased report of the current rate of severe complications for Federal Drug Administration (FDA) 510(k) cleared sacroiliac joint (SIJ) fusions and investigate the underlying cause of these complications. SUMMARY OF BACKGROUND DATA: The number of yearly SIJ fusions is on an upward trend. Currently, the most utilized implants to fuse the SIJ have been FDA 510(k) cleared devices. Studies reporting on complications following SIJ fusions are mostly industry-sponsored. MATERIALS AND METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database was searched for all reported FDA 510(k) cleared SIJ fusion device complications. Several data points were obtained from each report and recorded. The Hospital Inpatient National Statistics and the Center for Medicare and Medicaid Services (CMS) was also searched for the number of SIJ fusions performed each year. RESULTS: A search of the MAUDE database returned 1115 reports, with the first report on June 30, 2011, and the last report on July 28, 2020. Patient injury was the most common type of event reported at 97.5% (1080/1107). Death was reported in 3 patients (0.3%). Malposition was the most common device problem at 49.5% (548/1107). The root cause of these events was primarily user error at 58.2% (644/1107). Revision surgery or reoperation occurred in 92.8% (1028/1107) of reports. Data for SIJ fusions through CMS showed an overall trend of increasing yearly SIJ fusions. CONCLUSIONS: The majority of complications reported to MAUDE for FDA 510(k) cleared SIJ fusion devices are user error due to improper placement of implants. These complications are likely underreported, and there is currently no formal tracking system of total SIJ fusions performed to calculate accurate complication and revision rates. Patient injury and health care costs can potentially be reduced with improved education, training, and oversight, which is currently lacking.

Hip Arthroscopy for Femoroacetabular Impingement in Adolescents: 10-Year Patient-Reported Outcomes.

BACKGROUND: Previous studies have demonstrated hip arthroscopy to be an effective treatment for femoroacetabular impingement (FAI) in individuals 18 years of age and older. Long-term outcome data in the adolescent population, however, are limited. PURPOSE: To report 10-year outcomes after hip arthroscopy in adolescents with symptomatic FAI. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Prospectively collected data were analyzed on adolescent patients younger than 18 years of age who had hip arthroscopy between March 2005 and 2009 with a minimum 10-year follow-up. Patients were included if they were diagnosed with symptomatic FAI and an associated labral tear that was treated with repair. Patients were excluded if they had previous hip procedures, acetabular dysplasia (lateral center-edge angle, <20°), avascular necrosis, previous hip fracture or dislocation, or Legg-Calve-Perthes disease, or refused to participate. The primary patient-reported outcome measure was the Hip Outcome Score (HOS) Activities of Daily Living (ADL) subscale. In addition, the HOS-Sport, modified Harris Hip Score (mHHS), 12-Item Short Form Health Survey (SF-12), and patient satisfaction were collected. Failure was defined as patients having to undergo revision arthroscopy. RESULTS: There were 60 patients (70 hips) who met inclusion criteria and had a 10-year follow-up. The mean age of the cohort was 16 ± 1.2 years, with 21 male and 49 female hips. Seven hips (10%) required revision hip arthroscopy. All revisions occurred in female patients and were associated with global laxity as well as longer duration of symptoms before time of surgery. At a mean follow-up of 12 years (range, 10-14 years), patients who did not undergo revision surgery had significant improvements from preoperatively to postoperatively in HOS-ADL (from 64 to 92; P < .01), HOS-Sport (from 40 to 86; P < .01), mHHS (from 56 to 88; P < .01), and SF-12 Physical Component Summary (from 41 to 54; P < .01). The median patient satisfaction was 10 out of 10 (very satisfied). CONCLUSION: Hip arthroscopy for FAI with labral repair resulted in excellent patient-reported outcomes and satisfaction at a minimum of 10 years of follow-up. There was a 10% rate of revision surgery, which was associated with global laxity and longer duration of symptoms before surgery, which should be considered in patient selection.

Outcomes After Arthroscopic Hip Labral Reconstruction: A Systematic Review and Meta-analysis.

BACKGROUND: The acetabular labrum is critical to maintenance of hip stability and has been found to play a key role in preservation of the hip fluid seal. For irreparable labral damage, arthroscopic labral reconstruction is an evolving technique that has been shown to decrease hip pain and restore function. PURPOSE: To provide a comprehensive review of current literature for arthroscopic hip labral reconstruction, with a focus on determining if outcomes differ between autograft or allograft tissue. STUDY DESIGN: Systematic review and meta-analysis. METHODS: PubMed and Scopus online databases were searched with the key terms "hip,""labrum,""reconstruction," and "graft" in varying combinations. Procedures performed, complications, failures, and functional outcome measures were included in this analysis. The inverse variance method was used to calculate pooled estimates and 95% CIs. RESULTS: Eight studies with 537 hips were included. Mean age was 37.4 years (95% CI, 34.5-40.4 years), and mean follow-up time was 29 months (95% CI, 26-33 months). Survivorship after autograft reconstruction ranged from 75.7% to 100%, as compared with 86.3% to 90.0% in the allograft cohort. In the autograft cohort, failures included 0% to 13.2% conversion to total hip arthroplasty and 0% to 11.0% revision hip arthroscopy. Failures in the allograft cohort included 0% to 12.9% total hip arthroplasty conversion, 0% to 10.0% revision arthroscopy, and 0% to 0.8% open revision surgery. Based on 6 studies, the modified Harris Hip Score improved by a mean 29.0 points after labral reconstruction (P < .0001). CONCLUSION: Arthroscopic hip labral reconstruction results in clinically significant improvements in patient-reported outcomes. Our analysis indicates that there are no significant differences in outcomes based on graft type alone. A number of factors may determine graft choice, including patient preference, surgeon experience, operative time, morbidity, and cost. Proper patient selection based on age and severity of degenerative joint disease will also optimize outcomes after labral reconstruction.

Postoperative Pain Management Strategies in Hip Arthroscopy.

PURPOSE OF REVIEW: Hip arthroscopy is a rapidly growing field due to its significant diagnostic and therapeutic value in the management of numerous hip disorders. Adequate control of postoperative pain in patients undergoing hip arthroscopy continues to be a challenging and evolving area in orthopedics. In the absence of standardized protocols for pain management in these patients, a variety of different approaches have been utilized in an effort to find a regimen that is effective at reducing postoperative pain, narcotic consumption, and cost to the patient and healthcare system. The purpose of this article, therefore, is to provide a comprehensive review of current literature regarding postoperative pain management techniques in patients undergoing hip arthroscopy. RECENT FINDINGS: Recent literature demonstrates the importance of a multimodal approach to treat postoperative pain in patients undergoing hip arthroscopy. When a peripheral nerve block or intraoperative anesthetic is used in combination with a pre- and postoperative analgesic medication regimen, patients report less pain and postoperative narcotic consumption. Patient-reported pain scores and postoperative opioid use were similar between the different modalities, however, postoperative complications appear to be less in groups receiving intra-articular (IA) injection or local anesthetic infiltration (LAI) compared to peripheral nerve blocks. In summary, we present evidence that intraoperative techniques, such as IA injection or LAI, in conjunction with pre- and postoperative pain medications, offers an effective multimodal strategy for treating postoperative pain following hip arthroscopy. This topic is of increasing importance due to the need for cost-effective strategies of managing pain and decreasing opioid consumption following hip arthroscopy.

Aspirin: are patients actually taking it?-A quality assessment study.

BACKGROUND: The purpose of the study was to assess patient adherence to an aspirin-based prophylactic deep venous thromboembolism (DVT) care management plan after total lower extremity arthroplasty. METHODS: Using a cross-sectional study design, patients who underwent total hip or knee replacement surgery by a single senior surgeon were surveyed at their routine 6-week follow-up appointment regarding adherence to aspirin DVT prophylaxis. Postoperatively, patients were advised to take 325 mg of aspirin twice daily for 6 weeks to prevent DVT. RESULTS: Of the 101 patients surveyed, 45 underwent total hip arthroplasty while 56 underwent total knee arthroplasty. There were 48 (48%) patients who were still taking aspirin at their routine 6-week postoperative follow-up appointment and 53 (52%) patients who were not taking aspirin (nonadherent group). Of the latter, 3 (6%) never took aspirin postoperatively, 14 (26%) discontinued within 2 weeks postoperatively, and 23 (43%) did not take it any longer for half the time prescribed. In the nonadherent group, 8 patients reported that they felt they did not need the aspirin prophylaxis, 5 experienced side effects, and 10 were unsure of how long they needed to take it. There was 1 patient with a calf DVT and no episodes of pulmonary embolism. CONCLUSIONS: Over half of our study, patients did not finish their aspirin regimen. We suggest a consistent outline of medication duration throughout the pre/postop course and communication regarding aspirin cessation.

Timing of lower extremity frontal plane motion differs between female and male athletes during a landing task.

BACKGROUND: Female athletes are at a greater risk for noncontact anterior cruciate ligament injuries than male athletes. Gender differences in frontal plane kinematics (hip adduction, knee valgus, and ankle eversion) and temporal relationships that make up the components of dynamic knee valgus may explain this discrepancy. HYPOTHESIS: The authors hypothesized that women would reach peak frontal plane kinematic values earlier during landing compared with their male counterparts. STUDY DESIGN: Controlled laboratory study. METHODS: Hip, knee, and ankle 3-dimensional kinematics were measured using high-speed motion capture in 10 National Collegiate Athletic Association Division I female athletes and 10 male practice squad athletes during a drop-jump landing. Independent t tests were used to analyze each dependent variable to identify differences between genders. RESULTS: Maximum hip adduction, knee valgus, and ankle eversion occurred earlier in women than in men (mean differences 33.7% of stance [95% CI, 20.2%-47.2%], 41.7% [95% CI, 31.5%-51.6%], 16.5% of stance [95% CI, 7.3%-25.6%], respectively). Maximum hip adduction and knee valgus occurred before maximum knee flexion in women and after in men (mean differences 0.11 seconds [95% CI, 0.05-0.18 seconds], 0.19 seconds [95% CI, 0.13-0.25 seconds], respectively). Maximum ankle eversion occurred earlier in women than in men (mean difference 0.06 seconds [95% CI, 0.01-0.11 seconds]). There was a significant difference between genders for angular velocity of knee valgus (mean difference = 25.53 deg/sec [95% CI, 8.30-42.77 deg/sec]). CONCLUSION: Frontal plane kinematic temporal relationships at the hip, knee, and ankle differ between genders. The components of dynamic knee valgus peak during the deceleration phase in women and during the acceleration phase in men during a drop-jump landing. These data suggest that men and women employ a completely different kinematic landing/jumping strategy and that women land and collapse very rapidly into valgus compared with their male counterparts. CLINICAL RELEVANCE: The differences in timing of the components of dynamic knee valgus between women and men may contribute to the increased risk of noncontact anterior cruciate ligament injuries in female athletes. There may be implications for neuromuscular reeducation training in those at risk for anterior cruciate ligament injury so the components of dynamic valgus occur later in the landing phase of jumping.

A 5° medial wedge reduces frontal but not saggital plane motion during jump landing in highly trained women athletes.

Lower extremity mechanics during landing have been linked to traumatic and nontraumatic knee injuries, particularly in women's athletics. The effects of efforts to mitigate these risks have not been fully elucidated. We previously reported that a 5° medial wedge reduced ankle eversion and knee valgus. In the present report we further investigated the effect of a 5° medial wedge inserted in the shoes of female athletes on frontal plane hip motion, as well as ankle, knee, hip, and trunk saggital plane motion during a jump landing task. Kinematic data were obtained from 10 intercollegiate female athletes during jump landings from a 31 cm platform with and without a 5° medial wedge. Hip adduction was reduced 1.98° (95% CI 0.97-2.99°) by the medial wedge but saggital plane motions were unaffected. A 5° medial wedge reduces frontal plane motion and takes the knee away from a position associated with anterior cruciate ligament injury and patellofemoral pain syndrome. Although frontal plane motion was not captured it is unlikely to have increased in a bilateral landing task. Thus, it is likely that greater muscle forces were generated in these highly trained athletes to dissipate ground reaction forces when a medial wedge was in place. Additional investigation in younger and lesser trained athletes is warranted to assess the impact of orthotic devices on knee joint mechanics.