Supraspinatus pathology on MRI is associated with degree of weakness on dynamic clinical strength testing.

OBJECTIVE: To analyze shoulder strength and function in patients presenting with possible supraspinatus pathology and to ascertain if these clinical findings are associated with severity of supraspinatus pathology on MRI. MATERIALS AND METHODS: In total, 171 patients with presumptive rotator cuff pathology and with preserved strength on standard rotator cuff examination were prospectively recruited. Patients were subjected to bilateral shoulder strength testing employing dynamometry; this included isometric strength testing at 90° of abduction, followed by eccentric assessment of isotonic strength from full abduction through the full range of motion until the arm rested at the patient's side. We calculated absolute strength and symptomatic-to-asymptomatic arm (S/A) strength ratios. On subsequent shoulder MRI, supraspinatus pathology was designated into one of seven categories. The association between strength measurements and MRI findings was analyzed. RESULTS: Increasing lesion severity on MRI was associated with both decreasing absolute strength (no tear [59.9 N] to full-thickness tear [44.2 N]; P = 0.036) and decreasing S/A strength ratios during isotonic testing (no tear [91.9%] to full-thickness tear [65.3%]; P = 0.022). In contrast, there were no significant relationships between imaging severity and absolute strength or S/A strength ratios on isometric testing. CONCLUSION: Severity of supraspinatus pathology on MRI was associated with dynamic clinical function. These results validate the clinical correlation between MRI designations of supraspinatus pathology and function and suggest the need for future work to investigate utility of dynamic (versus isometric) rotator cuff physical examination maneuvers.

Accelerated versus standard physical therapy in patients with transtendinous rotator cuff repair: a propensity-matched cohort study.

BACKGROUND: Partial-thickness rotator cuff tears that remain symptomatic despite conservative management can be repaired operatively through a transtendinous approach. Although transtendinous repairs have been linked to superior long-term biomechanical outcomes compared with other surgical techniques, they are classically associated with early postoperative stiffness and a slower rate of recovery. PURPOSE: To examine the impact of expediting the physical therapy (PT) regimen after transtendinous repair on postoperative range of motion and complications. METHODS: The first 61 patients to receive accelerated PT after transtendinous repair were compared with a historical cohort of 61 patients who underwent standard postoperative management. The patients were propensity matched on age, sex, smoking status, and biceps procedure performed at the time of rotator cuff repair. Primary outcome measures included active range of motion (AROM) in forward flexion, abduction, external rotation, and internal rotation at 2 weeks, 6 weeks, 3 months, and 6 months postoperatively. Secondary outcome measures included development of severe stiffness or symptomatic rotator cuff retear at 1-year follow-up. Patients with full-thickness tears and those undergoing revision surgery or tear-completion and repair were excluded. RESULTS: The accelerated PT cohort showed significantly increased AROM at 6 weeks and 3 months postoperatively. At 6 weeks, AROM in forward flexion (137.0° vs. 114.9°; P < .001), abduction (126.1° vs. 105.3°; P = .009), and external rotation (51.7° vs. 36.5°; P = .005) were all significantly higher in the accelerated PT cohort. A similar increase was seen at 3 months, with superior forward flexion (147.5° vs. 134.0°; P = .01) and external rotation (57.7° vs. 44.0°; P = .008) in patients who received accelerated PT. Severe postoperative stiffness was significantly less common in the accelerated PT cohort (3.3% vs. 18.0%; P = .02), and there were no symptomatic retears (0.00%) in the accelerated PT cohort as compared with 1 symptomatic retear (1.64%) in the standard PT cohort (P = 1.00). CONCLUSION: Accelerated PT after transtendinous rotator cuff repair is associated with significant improvement in AROM at 6 weeks and 3 months postoperatively. Further, the early motion may help obviate the development of severe postoperative stiffness without any evidence of higher rotator cuff retear rates. LEVEL OF EVIDENCE: Level III; Retrospective Cohort Comparison; Treatment Study.

Mid-Term Results of Arthroscopic Synovectomy for Pigmented Villonodular Synovitis of the Hip.

PURPOSE: To analyze mid-term outcomes after arthroscopic synovectomy of both diffuse and nodular hip pigmented villonodular synovitis (PVNS). METHODS: This is a retrospective case series of patients that underwent hip arthroscopy for hip PVNS with a single senior surgeon between 2007 and 2016. Inclusion criteria were magnetic resonance imaging evidence, arthroscopic visualization, and/or histologic confirmation of PVNS; and a minimum of 3 years of follow-up. Concomitant pathology such as femoroacetabular impingement also was treated at the time of surgery. Primary outcome measures were recurrence of hip PVNS and the rate of revision hip surgery. Secondary outcomes were complications, visual analog scale pain score, pain relief, and patient satisfaction, and 6 patient-reported outcome measures were collected at latest follow-up. RESULTS: In a case series of 14 patients consisting of 6 (42.9%) male and 8 (57.1%) female patients, the mean operative age was 32.69 ± 12.73 years with a mean follow-up was 6.66 ± 1.87 years. PVNS type was determined intraoperatively: 5 (35.7%) patients had diffuse hip PVNS and 9 (64.3%) had nodular type. There was only 1 case (7.14%) of recurrence that was treated arthroscopically and no cases (0%) progressed to revision open synovectomy or arthroplasty. Mean patient-reported outcome measure scores were notable for a modified Harris Hip Score of 74.08 ± 16.84. The mean visual analog scale pain score decreased by 4.9 ± 1.7, which was significant with a P < .001, with a larger decrease in patients with localized type. CONCLUSIONS: This study presents a large case series of hip PVNS managed arthroscopically with mid-term follow-up of slightly over 6.5 years. The survival rate was 93%, with only 1 (7%) recurrence and 0 (0%) progression to revision open synovectomy or arthroplasty with 0 (0%) complications. We conclude that arthroscopic synovectomy is a reliable and effective treatment of hip PVNS. LEVEL OF EVIDENCE: Case Series, Level IV.

Endoscopic Repair of Full-Thickness Gluteus Medius and Minimus Tears-Prospective Study With a Minimum 2-Year Follow-Up.

PURPOSE: To evaluate the short-term outcomes of endoscopic repair of full-thickness gluteus medius and minimus tendon tears with a minimum of 2-year follow-up and add to the paucity of literature on abductor tendon tears. METHODS: All patients who underwent endoscopic abductor tendon repair between December 2013 and August 2017 were prospectively evaluated. The inclusion criteria for this study were primary full-thickness gluteal tendon tears and at least 2-years of follow-up. Clinical outcome data consisted of visual analog scale (VAS) pain score, hip abduction strength, Trendelenburg sign, complications, and patient-reported outcome measures (PROMs): modified Harris Hip Score, Hip Outcome Score, Non-arthritic Hip Scale, International Hip Outcome Tool-33, and Lower Extremity Functional Scale. RESULTS: A total of 15 hips, all full-thickness tears, met inclusion criteria with an average follow-up of 31.2 months, with no patients being excluded. On physical examination, there was a significant improvement in VAS pain score from 5.36 to 2.43 (P = .0243), hip abduction strength with 8 (53.3%) hips improving by at least 1 point (P = .02056), and resolution of Trendelenburg sign in all 15 hips at 2-years (P = .0019). The mean difference for all 6 PROMs was statistically significant, even after Bonferroni adjustment, with the majority of patient improvement exceeding the minimal clinically important difference (MCID) thresholds: modified Harris Hip Score: 86.67%, Hip Outcome Score-ADL: 86.67%, Hip Outcome Score-SSS: 66.67%, Non-arthritic Hip Scale: 93.33%, and International Hip Outcome Tool-33: 80%. Greater Goutallier grade was associated with a greater VAS pain score. There were no complications, including no retears. CONCLUSIONS: In this study of 15 hips with full-thickness gluteal tendon tears managed endoscopically, we found excellent outcomes that exceeded the MCID thresholds in the majority of patients at an average of 31.2 months follow-up, while offering the potential advantages of less tissue violation, ambulatory day surgery, and fewer complications compared with open repair. LEVEL OF EVIDENCE: Level 4, Case Series.

The new dynamic isotonic manipulation examination (DIME) is a highly sensitive secondary screening tool for supraspinatus full-thickness tears.

BACKGROUND: Traditional shoulder physical examination (PE) tests have suboptimal sensitivity for detection of supraspinatus full-thickness tears (FTTs). Therefore, clinicians may continue to suspect FTTs in some patients with negative rotator cuff PE tests and turn to magnetic resonance imaging (MRI) for definitive diagnosis. Consequently, there is a need for a secondary screening test that can accurately rule out FTTs in these patients to better inform clinicians which patients should undergo MRI. The purpose of this study was to assess the ability of 2 new dynamic PE tests to detect supraspinatus pathology in patients for whom traditional static PE tests failed to detect pathology. METHODS: We prospectively enrolled 171 patients with suspected rotator cuff pathology with negative findings on traditional rotator cuff PE, who underwent 2 new dynamic PE tests: first, measurement of angle at which the patient first reports pain on unopposed active abduction and, second, the dynamic isotonic manipulation examination (DIME). Patients then underwent shoulder magnetic resonance arthrogram. Data from the new PE maneuvers were compared with outcomes collected from magnetic resonance arthrogram reports. RESULTS: Pain during DIME testing had a sensitivity of 96.3% and 92.6% and a negative predictive value of 96.2% and 94.9% in the coronal and scapular planes, respectively. DIME strength ≤86.0 N had a sensitivity of 100% and 96.3% and a negative predictive value of 100% and 95.7% in the coronal and scapular planes, respectively. Pain at ≤90° on unopposed active abduction in the coronal plane had a specificity of 100% and a positive predictive value of 100% for supraspinatus pathology of any kind (ie, tendinopathy, "fraying," or tearing). CONCLUSION: DIME is highly sensitive for supraspinatus FTTs in patients with negative traditional rotator cuff PE tests for whom there is still high clinical suspicion of FTTs. Thus, this test is an excellent secondary screening tool for supraspinatus FTTs in patients for whom clinicians suspect rotator cuff pathology despite negative traditional static PE tests. Given its high sensitivity, a negative DIME test rules out supraspinatus FTT well in these patients, and can therefore better inform clinicians which patients should undergo MRI. In addition, the angle at which patients first report pain on unopposed active shoulder abduction is highly specific for supraspinatus pathology.

National Longitudinal Comparison of Patients Undergoing Surgical Management of Craniosynostosis.

PURPOSE: Limited cross-institutional studies compare strip craniectomy versus cranial vault remodeling (CVR) for craniosynostosis management. Given competing surgical preferences, the authors conducted a large-scale analysis of socioeconomic differences, costs, and complications between treatment options. METHODS: Nonsyndromic craniosynostosis patients receiving strip craniectomies or CVR were identified in the Kids' Inpatient Database for years 2000 to 2009. Demographics, socioeconomic background, hospital characteristics, charge, and outcomes were tabulated. Univariate and multivariate analyses were performed for comparison. RESULTS: Two hundred fifty-one strip craniectomies and 1811 CVR patients were captured. Significantly more strip craniectomy patients were White while more CVR patients were Hispanic or Black (P < 0.0001). Strip craniectomy patients more often had private insurance and CVR patients had Medicaid (P < 0.0001). Over time, CVR trended toward treating a higher proportion of Hispanic and Medicaid patients (P = 0.036). Peri-operative charges associated with CVR were $27,962 more than strip craniectomies, and $11,001 after controlling for patient payer, income, bedsize, and length of stay (P < 0.0001). Strip craniectomies were performed more frequently in the West and Midwest, while CVR were more common in the South (P = 0.001). Length of stay was not significant. Postsurgical complications were largely equivocal; CVR was associated with increased accidental puncture (P = 0.025) and serum transfusion (P = 0.002). CONCLUSION: Our national longitudinal comparison demonstrates widening socioeconomic disparities between strip craniectomy and CVR patients. Cranial vault remodeling is more commonly performed in underrepresented minorities and patients with Medicaid, while strip craniectomy is common in the White population and patients with private insurance. While hospital charges and complications were higher among CVR, differences were smaller than expected.

A review of the design, manufacture, and outcomes of custom total joint replacement implants available in the United States.

Custom total joint replacement (TJA) implants, specifically designed and manufactured for each patient, have emerged as surgeons seek to improve functional outcomes of primary total joint replacement, as well as treat patients with complex primary deformities, bone defects, and revision surgeries. The purpose of this review is to present the various custom total hip and knee arthroplasty implants available in the United States for primary and revision cases, so that surgeons can understand the design considerations and manufacturing processes of custom implants, as well as their performance compared to standard implants.

Hip Arthroscopy Versus Physical Therapy for the Treatment of Symptomatic Acetabular Labral Tears in Patients Older Than 40 Years: 24-Month Results From a Randomized Controlled Trial.

BACKGROUND: The indications for hip arthroscopy in patients aged ≥40 years remain controversial, as observational studies have suggested that advanced age portends poor functional outcomes, poor durability of improvement, and high rates of conversion to total hip arthroplasty. PURPOSE: To compare hip arthroscopy versus nonoperative management for symptomatic labral tears in patients aged ≥40 years with limited radiographic osteoarthritis. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: This single-surgeon, parallel randomized controlled trial included patients aged ≥40 years with limited osteoarthritis (Tönnis grades 0-2) who were randomized 1:1 to arthroscopic surgery with postoperative physical therapy (SPT) or physical therapy alone (PTA). Patients who received PTA and achieved unsatisfactory improvement were permitted to cross over to SPT after completing ≥14 weeks of physical therapy (CO). The primary outcomes were the International Hip Outcome Tool-33 score and modified Harris Hip Score at 24 months after surgery, and secondary outcomes included other patient-reported outcome measures and the visual analog scale for pain. The primary analysis was performed on an intention-to-treat basis using linear mixed-effects models. Sensitivity analyses included modified as-treated and treatment-failure analyses. RESULTS: A total of 97 patients were included, with 52 (53.6%) patients in the SPT group and 45 (46.4%) patients in the PTA group. Of the patients who underwent PTA, 32 (71.1%) patients crossed over to arthroscopy at a mean of 5.10 months (SD, 3.3 months) after physical therapy initiation. In both intention-to-treat and modified as-treated analyses, the SPT group displayed superior mean patient-reported outcome measure and pain scores across the study period for nearly all metrics relative to the PTA group. In the treatment-failure analysis, the SPT and CO groups showed greater improvement across all metrics compared with PTA; however, post hoc analyses revealed no significant differences in improvement between the SPT and CO groups. No significant differences were observed between groups in rates of total hip arthroplasty conversion. CONCLUSION: In patients ≥40 years of age with limited osteoarthritis, hip arthroscopy with postoperative physical therapy led to better outcomes than PTA at a 24-month follow-up. However, additional preoperative physical therapy did not compromise surgical outcomes and allowed some patients to avoid surgery. When surgery is indicated, age ≥40 years should not be considered an independent contraindication to arthroscopic acetabular labral repair. REGISTRATION: NCT03909178 (ClinicalTrials.gov identifier).

Biceps tenotomy vs. tenodesis in patients undergoing transtendinous repair of partial thickness rotator cuff tears.

Background: Patients with partial thickness rotator cuff tears (PTRCTs) often present with concurrent pathology of the long head of the biceps tendon (LHBT). To address both conditions simultaneously, long head of the biceps (LHB) tenotomy or tenodesis can be performed at the time of arthroscopic rotator cuff repair (RCR). This study aims to compare postoperative shoulder active range of motion (AROM) and complications following transtendinous RCR with concurrent LHB tenodesis or tenotomy. Methods: A total of 90 patients with PTRCTs met inclusion criteria for this study. Patients who underwent tear-completion-and-repair, revision surgery, or open repair of the LHB tendon were excluded. Patients were stratified into tenotomy, arthroscopic suprapectoral tenodesis, or no biceps operation cohorts and were propensity matched 1:1:1 on age, sex, body mass index, and smoking status. Primary outcome measures included AROM in forward flexion, abduction, external rotation, and internal rotation at 6 weeks, 3 months, and 6 months postoperatively. The development of severe stiffness and rates of rotator cuff retear at final follow-up were recorded as secondary outcomes. Results: When comparing the tenotomy and tenodesis cohorts, tenotomy patients were found to have increased AROM at 3 months in forward flexion (153.2° vs. 130.1°, P = .004), abduction (138.6° vs. 114.2°, P = .019), and external rotation (60.4° vs. 43.8°, P = .014), with differences in forward flexion remaining significant at 6 months (162.4° vs. 149.4°, P = .009). There were no significant differences in interval rates of recovery in any plane between cohorts. Additionally, there were no significant differences in rates of symptomatic retears between groups (P = .458). Rates of severe postoperative stiffness approached but did not achieve statistical significance between tenotomy (4.2%) and tenodesis (29.2%) cohorts (P = .066). Smoking status was a significant predictor of severe stiffness (odds ratio, 13.69; P = .010). Conclusion: Despite significant differences in absolute AROM between cohorts, the decision to perform tenotomy or tenodesis was not found to differentially affect rates of AROM recovery for patients undergoing arthroscopic transtendinous RCR for PTRCT. Notably, however, transient stiffness complications were more commonly observed in smokers, and data trends suggested an increased risk of stiffness for patients undergoing LHB tenodesis. Overall, postoperative stiffness is likely multifactorial and attributable to both patient- and procedure-specific factors, and LHB tenotomy may be more appropriate for patients with risk factors for developing stiffness postoperatively.

Association Between Chondrolabral Junction Breakdown and Conversion to Total Hip Arthroplasty After Hip Arthroscopy for Symptomatic Labral Tears: Minimum 8-Year Follow-up.

BACKGROUND: Arthroscopic treatment of femoroacetabular impingement (FAI) and symptomatic labral tears confers short- to midterm benefits, yet further long-term evidence is needed. Moreover, despite the physiological and biomechanical significance of the chondrolabral junction (CLJ), the clinical implications of damage to this transition zone remain understudied. PURPOSE: To (1) report minimum 8-year survivorship and patient-reported outcome measures after hip arthroscopy for FAI and (2) characterize associations between outcomes and patient characteristics (age, body mass index, sex), pathological parameters (Tönnis angle, alpha angle, type of FAI, CLJ breakdown), and procedures performed (labral management, FAI treatment, microfracture). STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: This retrospective cohort study included patients who underwent primary hip arthroscopy for symptomatic labral tears secondary to FAI by a single surgeon between 2002 and 2013. All patients were ≥18 years of age with minimum 8-year follow-up and available preoperative radiographs. The primary outcome was conversion to total hip arthroplasty (THA), and secondary outcomes included revision arthroscopy, patient-reported outcome measures, and patient satisfaction. CLJ breakdown was assessed using the Beck classification. Kaplan-Meier estimates and weighted Cox regression were used to estimate 10-year survivorship (no conversion to THA) and identify risk factors associated with THA conversion. RESULTS: In this study of 174 hips (50.6% female; mean age, 37.8 ± 11.2 years) with mean follow-up of 11.1 ± 2.5 years, the 10-year survivorship rate was 81.6% (95% CI, 75.9%-87.7%). Conversion to THA occurred at a mean 4.7 ± 3.8 years postoperatively. Unadjusted analyses revealed several variables significantly associated with THA conversion, including older age; higher body mass index; higher Tönnis grade; labral debridement; and advanced breakdown of the CLJ, labrum, or articular cartilage. Survivorship at 10 years was inferior in patients exhibiting severe (43.6%; 95% CI, 31.9%-59.7%) versus mild (97.9%; 95% CI, 95.1%-100%) breakdown of the CLJ (P < .001). Multivariable analysis identified worsening CLJ breakdown (weighted hazard ratio per 1-unit increase, 6.41; 95% CI, 3.11-13.24), older age (1.09; 95% CI, 1.04-1.14), and higher Tönnis grade (4.59; 95% CI, 2.13-9.90) as independent negative prognosticators (P < .001 for all). CONCLUSION: Although most patients achieved favorable minimum 8-year outcomes, several pre- and intraoperative factors were associated with THA conversion; of these, worse CLJ breakdown, higher Tönnis grade, and older age were the strongest predictors.

Puncture Capsulotomy Technique for Hip Arthroscopy: Midterm Functional Outcomes.

Background: The most common surgical approaches in hip arthroscopy are interportal and T-capsulotomy. However, these methods may introduce capsular instability. Puncture capsulotomy preserves capsuloligamentous integrity by avoiding iatrogenic transection of the iliofemoral capsular ligament. Purpose: To present minimum 2-year functional outcomes for patients who underwent arthroscopic treatment for acetabular labral tears and concomitant femoroacetabular impingement using the puncture capsulotomy technique. Study Design: Case series; Level of evidence, 4. Methods: The authors conducted a retrospective review of prospectively collected data on patients who underwent arthroscopic acetabular labral tear treatment between December 2013 and May 2019. Included were patients aged ≥18 years who underwent hip arthroscopy by a single surgeon and completed a minimum of 2 years of patient-reported outcome measure (PROM) surveys. Intraoperatively, patients underwent hip arthroscopy via puncture capsulotomy to treat labral tears and any concomitant femoroacetabular impingement. Clinical outcome data consisted of PROMs. Results: A total of 163 hips were included; the mean patient follow-up was 30.4 months (range, 24-60 months; 95% CI, 28.5-32.3 months). Patients had a mean age of 37.9 years (range, 36.1-39.6 years), with a mean body mass index of 25.9 (range, 25.2-26.5). There were significant improvements in mean [95% CI] baseline to final follow-up scores for the 33-Item International Hip Outcome Tool (iHOT-33) (39.6 [36.8-42.4] vs 76.1 [72.7-79.6]), Hip Outcome Score-Activities of Daily Living (70.0 [67.0-73.0] vs 89.3 [87.3-91.3]), modified Harris Hip Score (60.1 [57.9-62.4] vs 84.9 [82.5-87.2]), and Hip Outcome Score-Sports Specific Subscale (41.8 [37.9-45.6] vs 75.7 [71.7-79.7]) (P < .001 for all). Additionally, the mean [95% CI] visual analog scale pain scores were noted to significantly improve throughout the duration of the postoperative period (from 6.3 [5.9-6.7] to 2.2 [1.8-2.6]; P < .001). There were no incidences of infection, avascular necrosis of the femoral head, dislocation/instability, or femoral neck fracture. At the 2-year follow-up, 81.0%, 62.0%, and 58.9% of hips achieved previously published clinically meaningful iHOT-33 thresholds for minimally clinically important difference, Patient Acceptable Symptom Score, and substantial clinical benefit, respectively. Conclusion: Puncture capsulotomy demonstrated significantly improved functional and clinically meaningful outcomes at a minimum 2-year follow-up, along with a minimal complication rate.

Labral Reconstruction via Capsular Augmentation Maintains Perfusion to the Acetabular Labrum and Locally Transferred Autograft: An in Vivo Laser Doppler Flowmetry Analysis.

Background: The purpose of the present study was to examine the effects of arthroscopic labral repair with capsular augmentation on blood flow in vivo with use of laser Doppler flowmetry (LDF) to measure microvascular perfusion of the labrum and autograft tissue. Methods: The present prospective case series included patients ≥18 years old who underwent arthroscopic acetabular labral repair with capsular augmentation; all procedures were performed by a single surgeon between 2018 and 2022. The LDF probe measured microvascular blood flow flux within 1 mm3 of the surrounding labral and capsular tissue of interest. Mean baseline measurements of flux were compared with readings immediately following capsular elevation and after completing labral augmentation. Blood flux changes were expressed as the percent change from the baseline measurements. Results: The present study included 41 patients (24 men [58.5%] and 17 women [41.5%]) with a mean age (and standard deviation) of 31.3 ± 8.4 years, a mean BMI of 24.6 ± 3.4 kg/m2, a mean lateral center-edge of angle 35.3° ± 4.9°, a mean Tönnis angle of 5.8° ± 5.8°, and a mean arterial pressure of 93.7 ± 10.9 mm Hg. Following capsular elevation, the mean percent change in capsular blood flow flux was significantly different from baseline (-9.24% [95% confidence interval (CI), -18.1% to -0.04%]; p < 0.001). Following labral augmentation, the mean percent change in labral blood flow flux was significantly different from baseline both medially (-22.3% [95% CI, -32.7% to -11.9%]; p < 0.001) and laterally (-32.5% [95% CI, -41.5% to -23.6%]; p = 0.041). There was no significant difference between the changes in medial and lateral perfusion following repair (p = 0.136). Conclusions: Labral repair with capsular augmentation sustains a reduced blood flow to the native labrum and capsular tissue at the time of fixation. The biological importance of this reduction is unknown, but these findings may serve as a benchmark for other labral preservation techniques and support future correlations with clinical outcomes. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Interpretation of regulatory factors for 3D printing at hospitals and medical centers, or at the point of care.

3D printing is revolutionizing the medical device landscape through its ability to rapidly create patient-specific anatomic models, surgical instruments, and implants. Recent advances in 3D printing technology have allowed for the creation of point-of-care (PoC) 3D printing centers. These PoC centers blur the line between healthcare provider, medical center, and device manufacturer, creating regulatory ambiguity. The United States Food & Drug Administration (FDA) currently regulates 3D printed devices through existing medical device regulations. However, the FDA is increasingly interested in developing guidelines and regulations specifically for PoC 3D printing due to its rapid adoption across the healthcare institutions. In this article, we review the regulatory framework that governs medical devices, discuss how PoC 3D printing falls within this framework, and describe a novel conceptual framework that the FDA has proposed. Finally, through analysis of the aforementioned regulations and discussions with industry medical 3D printing regulatory experts, we provide recommendations for PoC medical 3D printing best practices so that institutions are best positioned to utilize this revolutionary technology safely and effectively.

Arthroscopic Acetabular Labral Repair Versus Labral Debridement: Long-term Survivorship and Functional Outcomes.

Background: Arthroscopic treatment for labral tears includes debridement and repair. Long-term studies have failed to demonstrate a difference between these treatments in terms of conversion to total hip arthroplasty (THA). Purpose: To investigate 2 different labral treatments, debridement and repair, using an adjusted analysis to evaluate long-term conversion to THA. Study Design: Cohort study; Level of evidence, 3. Methods: This was a retrospective cohort study of patients who underwent hip arthroscopy by a single surgeon between April 2007 and October 2014. Postoperative follow-up information included conversion to THA, patient satisfaction, and patient-reported outcome measures (modified Harris Hip Score; Hip Outcome Score, Activities of Daily Living and Sports Specific subscales; International Hip Outcome Tool; Nonarthritic Hip Score; and Lower Extremity Functional Scale). Results: Of the 204 hips included in the study, 99 (48.5%) underwent labral repair, and 105 (51.5%) underwent debridement. In total, 28 (13.7%) of the 204 patients underwent conversion to THA within 10 years after hip arthroscopy (labral repair: 5 [5.0%] vs labral debridement: 23 [21.9%]). Labral repair was associated with a significantly lower risk of conversion to THA compared with debridement (hazard ratio [HR] = 0.24; 95% CI, 0.07-0.74; P = .014). Additional factors associated with risk of conversion to THA included older age at the time of arthroscopy (HR = 1.06 per year; 95% CI, 1.02-1.11; P = .002) and Tönnis grade (HR = 2.39; CI, 1.14-5.41; P = .026). Abrasion chondroplasty, acetabuloplasty, body mass index, Outerbridge grade, and radiographic femoroacetabular impingement were not found to be significantly associated with risk of THA. No significant difference in patient satisfaction was found between treatment groups, and for patients who did not convert to THA, there was no difference in mean patient-reported outcome scores at final follow-up. Conclusion: Patients who underwent labral repair were less likely to convert to THA compared with patients who underwent labral debridement, despite adjustment for differences in baseline patient characteristics and preexisting pathology. Additional factors associated with a lower rate of hip survival were older age and osteoarthritis at the time of hip arthroscopy.

Functional Outcomes of Arthroscopic Acetabular Labral Repair with and without Bone Marrow Aspirate Concentrate.

BACKGROUND: Osteoarthritis (OA) of the hip is a debilitating condition associated with inferior outcomes in patients undergoing hip arthroscopy. To provide symptom relief and improve outcomes in these patients, bone marrow aspirate concentrate (BMAC) has been applied as an adjuvant therapy with the hope of halting progression of cartilage damage. The current study examined the clinical efficacy of BMAC application in patients undergoing arthroscopic acetabular labral repair by comparing patient-reported outcome measures (PROMs) between groups with and without BMAC application. METHODS: Patients who received BMAC during arthroscopic acetabular labral repair from December 2016 to June 2019 were compared with a control cohort that underwent the same procedure but did not receive BMAC from November 2013 to November 2016. Patients in both cohorts were asked to prospectively complete PROMs prior to surgery and at 3, 6, 12, and 24-month follow-up intervals; those who completed the PROMs at enrollment and the 12-month follow-up were included in the study. An a priori subgroup analysis was performed among patients with moderate cartilage damage (Outerbridge grade 2 or 3). The analyses were adjusted for any differences in baseline factors between groups. RESULTS: Sixty-two patients with BMAC application were compared with 62 control patients without BMAC application. When compared with the no-BMAC cohort, the BMAC cohort did not report significantly different mean International Hip Outcome Tool-33 (iHOT-33) scores at any postoperative time point. However, when patients with moderate cartilage damage were compared across groups, the BMAC cohort reported significantly greater mean (95% confidence interval) scores than the no-BMAC cohort at the 12-month (78.6 [72.4 to 84.8] versus 69.2 [63.3 to 75.2]; p = 0.035) and 24-month (82.5 [73.4 to 91.6] versus 69.5 [62.1 to 76.8]; p = 0.030) follow-up. Similarly, these patients reported greater score improvements at 12 months (37.3 [30.3 to 44.3] versus 25.4 [18.7 to 32.0]; p = 0.017) and 24 months (39.6 [30.4 to 48.7] versus 26.4 [19.1 to 33.8]; p = 0.029). CONCLUSIONS: Patients with moderate cartilage injury undergoing arthroscopic acetabular labral repair with BMAC application reported significantly greater functional improvements when compared with similar patients without BMAC application. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Comparing the Risk of Osteonecrosis of the Femoral Head Following Intra-Articular Corticosteroid and Hyaluronic Acid Injections.

BACKGROUND: Although intra-articular corticosteroid injections (CSIs) are a cornerstone in the nonoperative management of hip pathology, recent reports have raised concerns that they may cause osteonecrosis of the femoral head (ONFH). However, these studies might have been limited by nonrepresentative patient samples. Therefore, the purpose of this study was to assess the incidence of ONFH after CSI and compare it with the incidence in a similar patient population that received a non-CSI injection. METHODS: This was a retrospective propensity-matched cohort study of patients in the MarketScan database who underwent an intra-articular hip injection from 2007 to 2017. Patients receiving hip CSIs were matched 4:1 with patients receiving hip hyaluronic acid injections (HAIs) based on age, sex, geographic region, comorbidities, type of hip pathology, injection year, and baseline and follow-up time using propensity scores. The patients' first injections were identified, and the time to development of ONFH was analyzed using Kaplan-Meier curves and Cox proportional-hazards models. Patients with a history of osteonecrosis or those who received both types of injections were excluded. RESULTS: A total of 3,710 patients undergoing intra-articular hip injection were included (2,968 CSIs and 742 HAIs; mean [standard deviation] age, 53.1 [9.2] years; 55.4% men). All baseline factors were successfully matched between the groups (all p > 0.57). The estimated cumulative incidence (95% confidence interval [CI]) of ONFH for CSI and HAI patients was 2.4% (1.8% to 3.1%) versus 2.1% (1.1% to 3.5%) at 1 year and 2.9% (2.2% to 3.7%) versus 3.0% (1.7% to 4.8%) at 2 years (hazard ratio, 1.05; 95% CI, 0.59 to 1.84; p = 0.88). The results held across a range of sensitivity analyses. CONCLUSIONS: The incidence of ONFH after intra-articular hip injection was similar between patients who received CSIs and those who received HAIs. Although this study could not determine whether intra-articular injections themselves (regardless of the drug that was used) lead to ONFH, the results suggest that ONFH after CSI often may be due, in part, to the natural course of the underlying disease. Future randomized controlled trials are needed to definitively answer this question; in the interim, clinicians may be reassured that they may continue judicious use of CSIs as clinically indicated. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Limitations of Postless Hip Arthroscopy for a Patient with Coxa Profunda: A Case Report.

CASE: A 27-year-old man with coxa profunda and a right acetabular labral tear presented for surgical re-evaluation after a postless arthroscopic labral repair was attempted at an outside institution and aborted because of inadequate distraction during portal placement. Arthroscopic labral repair with a perineal post was subsequently performed without complications. CONCLUSION: Indications and limitations of postless hip distraction are seldom discussed in the literature. This report examines possible limitations of postless hip distraction for a patient with coxa profunda. Careful radiographic evaluation of hip anatomy may be essential for patients with deep hip sockets to determine the best-suited distraction technique.

Hip Arthroscopy Versus Physical Therapy for the Treatment of Symptomatic Acetabular Labral Tears in Patients Older Than 40 Years: A Randomized Controlled Trial.

BACKGROUND: Previous observational studies have suggested poor results of arthroscopic surgery for the treatment of acetabular labral tears in patients older than 40 years. PURPOSE: To compare hip arthroscopy versus nonoperative management for symptomatic labral tears in patients older than 40 years who have limited radiographic osteoarthritis. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: In this single-surgeon, parallel randomized controlled trial, patients older than 40 years who had symptomatic, MRI-confirmed labral tears and limited radiographic osteoarthritis (Tönnis grades 0-2) were randomized 1:1 to arthroscopic surgery with postoperative physical therapy (SPT) or physical therapy alone (PTA) using an electronic randomization program. PTA patients who achieved unsatisfactory improvement were permitted to cross over to SPT after completing ≥14 weeks of physical therapy. The primary outcomes were International Hip Outcome Tool (iHOT-33) and modified Harris Hip Score (mHHS) at 12 months after randomization, and secondary outcomes included other patient-reported outcome measures and the visual analog scale. Outcomes were assessed at baseline and at 3, 6, and 12 months after randomization. Primary analysis was performed on an intention-to-treat basis using linear mixed-effect models. Sensitivity analyses included modified as-treated analysis and treatment-failure analysis. Due to infeasibility, patients and health care providers were both unblinded. RESULTS: The study enrolled 90 patients (46 [51.1%] SPT; 44 [48.9%] PTA); of these, 81 patients (42 [51.9%] SPT; 39 (48.1%) PTA) completed 12-month follow-up. A total of 28 of the 44 PTA patients crossed over to SPT within the study period (63.6% crossover). Intention-to-treat analysis revealed significantly greater iHOT-33 scores (+12.11; P = .007) and mHHS scores (+6.99 points; P = .04) in the SPT group than the PTA group at 12 months. Modified as-treated analysis revealed that these differences exceeded the minimal clinically important difference of 10.0 points (SPT-PTA iHOT-33, +11.95) and 8.0 points (SPT-PTA mHHS, +9.76), respectively. CONCLUSION: In patients older than 40 years with limited osteoarthritis, arthroscopic acetabular labral repair with postoperative physical therapy led to better outcomes than physical therapy alone. Thus, age over 40 years should not be considered a contraindication to arthroscopic acetabular labral repair. REGISTRATION: NCT03909178 (ClinicalTrials.gov identifier).

Minimum 2-Year Functional Outcomes of Patients Undergoing Capsular Autograft Hip Labral Reconstruction.

BACKGROUND: There is a paucity of literature on arthroscopic capsular autograft labral reconstruction. PURPOSE: To report midterm functional outcomes for patients undergoing acetabular labral repair with capsular autograft labral reconstruction. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: This is a retrospective case series of prospectively collected data on patients who underwent arthroscopic acetabular labral repair by the senior surgeon between March 2013 and August 2018. The inclusion criteria for this study were adult patients aged 18 years or older who underwent primary hip arthroscopy for arthroscopic capsular autograft labral reconstruction. Exclusion criteria were <2 years of postoperative follow-up, elective disenrollment from study before 2-year follow-up, or repeat ipsilateral hip surgery before 2-year follow-up. Intraoperatively, patients underwent capsular autograft hip labral reconstruction if they were found to have a labrum with hypoplastic tissue (width <5 mm), complex tearing, or frank degeneration of native tissue. Clinical outcome data consisted of patient-reported outcome measures. RESULTS: A total of 97 hips (94 patients) met the inclusion criteria with a mean final follow-up of 28.2 months (95% CI, 26.0-30.4). Patients had a mean age of 39.0 years (95% CI, 36.8-41.2) with a mean body mass index of 25.8 (95% CI, 24.9-26.7). When compared with baseline (40.4 [95% CI, 36.7-44.2]), the mean international Hip-Outcome Tool-33 (iHOT-33) scores were significantly greater at 3-month (60.9 [95% CI, 56.8-64.9]; P < .001), 6-month (68.8 [95% CI, 64.7-72.9]; P < .001), 12-month (73.2 [95% CI, 68.9-77.5]; P < .001), and final (76.6 [95% CI, 72.4-80.8]; P < .001) follow-up. At 2-year follow-up, 76.3%, 65.5%, and 60.8% of patients' iHOT-33 scores exceeded clinically meaningful outcome thresholds for minimally clinically important difference (MCID), patient-acceptable symptomatic state, and substantial clinical benefit, respectively. CONCLUSIONS: In this study of 97 hips undergoing arthroscopic labral repair with capsular autograft labral reconstruction, we found favorable outcomes that exceeded the MCID thresholds in the majority of patients at a mean 28.2 months' follow-up. Future studies should compare outcomes between this technique and other methods of autograft and allograft reconstruction to determine differences in patient-reported outcomes, donor-site morbidity, and complications.