VARIABILITY IN EVALUATION AND TREATMENT OF PEDIATRIC TIBIAL TUBERCLE FRACTURES AMONGST PEDIATRIC ORTHOPAEDIC SURGEONS

Introduction: Tibial tubercle fractures are uncommon injuries typically seen in adolescents approaching skeletal maturity. No evidence based clinical practice guidelines currently exist regarding clinical management of both operative and nonoperative fractures. Purpose: To determine the variability in clinical management of tibial tubercle fractures among a group of pediatric orthopaedic surgeons. Methods: Nine fellowship trained academic pediatric orthopaedic surgeons reviewed 51 anteroposterior and lateral knee radiographs with associated case age (mean: 13.6yrs, range: 9-16yrs) and gender (86%male). Respondents were asked to describe each fracture using the Ogden classification (Type 1-5 with A/B modifiers), desired radiographic workup, operative vs. nonoperative treatment strategy, and plans for post treatment follow-up. Interrater reliability was determined among the surgeons using Fleiss Kappa analysis. Results: Fair agreement was reached when classifying the fracture type using the Ogden classification (k=0.39,p<0.001). There was slight agreement when determining if CT (k=0.10,p<0.001) should be ordered and when rating concern for compartment syndrome (k=0.17,p<0.001). Overall, surgeons had moderate agreement on whether to treat the fractures operatively vs. nonoperatively (k=0.51,p<0.001). Nonoperative management was selected for 80.4%(45/56) of Type 1A fractures. Respondents selected operative treatment for 75% (30/40) of Type 1B, 58.3% (14/24) of Type 2A, 97.4%(74/76) of Type 2B, 90.7%(39/43) of Type 3A, 96.3%(79/82) of Type 3B, 71.9%(87/121) of Type 4, and 94.1%(16/17) of Type 5 fractures. Regarding operative treatment, moderate agreement was reached when evaluating the emergent nature of the fracture (k=0.44,p<0.001) and surgical technique (k=0.44, p<0.001). However, only fair/slight agreement was reached when selecting the specifics of operative treatment including surgical fixation technique (k=0.25,p<0.001), screw type (k=0.26, p<0.001), screw size (k=0.08,p<0.001), use of washers (k=0.21,p<0.001), and performing a prophylactic anterior compartment fasciotomy (k=0.20,p<0.001). There was moderate agreement on radiographic work up at first (k=0.5,p<0.0011) and final (k=0.49,p<0.001) follow up visits. Surgeons had moderate agreement on plans to remove hardware (k=0.39,p<0.001). Non-operative treatment of fractures was observed to have only fair agreement (k=0.29,p<0.001). Furthermore, surgeons had fair/moderate agreement regarding the specifics of nonoperative treatment including degree of knee extension during immobilization (k=0.46,p<0.001), length of immobilization (k=0.34,p<0.001), post treatment weight bearing status (k=0.30,p<0.001), and post treatment rehabilitation (k=0.34,p<0.001). Finally, there was moderate agreement on radiographic work up at first (k=0.51,p<0.001) and final follow up (k=0.46,p<0.001). Conclusion: Significant variability exists between surgeons when evaluating and treating pediatric tibial tubercle fractures. Future studies should aim to create best practice guidelines for pediatric orthopaedic surgeons to reference when treating these fractures. [Table: see text]

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Treatment of Pectoralis Major Tendon Tears: A Systematic Review and Meta-Analysis of Operative and Nonoperative Treatment

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120s00411 ◽

2020 ◽

Vol 8 (7_suppl6) ◽

pp. 2325967120S0041

Author(s):

Blake Bodendorfer ◽

Brian McCormick ◽

David Wang ◽

Christine Conroy ◽

Caroline Fryar ◽

...

Keyword(s):

Systematic Review ◽

Operative Treatment ◽

Mixed Model ◽

Meta Analysis ◽

Random Effect ◽

Nonoperative Treatment ◽

Pectoralis Major ◽

Isokinetic Strength ◽

Tendon Tears

Objectives: The incidence of pectoralis major tendon tears is rising, and repair is generally considered, but there is a paucity of comparative data to demonstrate the superiority of operative treatment. We sought to compare the outcomes of operative and nonoperative treatment of pectoralis major tendon tears. We hypothesized that repair would result in superior outcomes compared to nonoperative treatment. Methods: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic review of the literature was completed using MEDLINE, SPORTDiscus, CINAHL, Cochrane, Embase and Web of Science databases. English-language studies were included with a minimum of 6 months average follow-up and 5 cases per study. Methodological Index for Nonrandomized Studies was utilized to assess the quality of the existing literature. Meta-analysis of pooled mechanisms of injury and outcomes was completed. Pooled effect-sizes were calculated from random effects models. Continuous variables were assessed using mixed model analysis with the individual study designated as a random effect and the desired treatment for comparison as a fixed effect. Bivariate frequency data was transformed using the Freeman-Tukey log-linear transformation for variance stabilization and then assessed using a mixed model with a study-level random effect and subsequently back-transformed. Significance was set at P<.05. Results: Twenty-three articles with 664 injuries met the inclusion criteria for comparison (Figure 1). All patients were male with 63.2% of injuries occurring during weight training, with an average age of 31.48 years and follow-up of 37.02 months. Included studies had moderately high methodological quality. Operative treatment was significantly superior to nonoperative treatment with a relative improvement of functional outcome by 0.70 (P=.027), full isometric strength by 77.07% (P<.001), isokinetic strength by 28.86% (P<.001) compared to the uninjured arm, cosmesis satisfaction by 13.79% (P=.037), and resting deformity by 98.85% (P<.001) (Table 1). There was an overall complication rate of 14.21%, including a 3.08% rate of rerupture, for operative treatment. Conclusion: Pectoralis major tendon repair resulted in significantly superior outcomes as compared to nonoperative treatment with an associated 14.21% complication rate. There was a statistically significant improvement in functional outcome, isokinetic strength, isometric strength, cosmesis, and resting deformity. [Figure: see text][Table: see text]

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OPERATIVE DECISION-MAKING FOR PEDIATRIC TIBIAL SPINE FRACTURES: ASSESSING THE EFFECT OF SURGEON EXPERIENCE AND RISK-AVERSION AND PATIENT AGE, SEX, INJURY TYPE, AND ATHLETIC LEVEL USING A MIXED EFFECTS MODEL

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967119s00129 ◽

2019 ◽

Vol 7 (3_suppl) ◽

pp. 2325967119S0012

Author(s):

Alexander J. Adams ◽

Nathan N. O’Hara ◽

Joshua M. Abzug ◽

Aristides I. Cruz ◽

Henry B. Ellis ◽

...

Keyword(s):

Surgical Treatment ◽

Operative Treatment ◽

Risk Taking ◽

Spine Fractures ◽

Type Ii ◽

Orthopaedic Surgeons ◽

Tibial Spine ◽

Fracture Displacement ◽

Surgeon Training ◽

Pediatric Orthopaedic

Background: Tibial spine fractures most commonly occur in children aged 8 to 14 years and are occasionally seen in adults. Although the annual incidence is 3 per 100,000 children, they account for 2-5% of pediatric knee injuries with effusions and are associated with substantial complications including ACL deficiency and arthrofibrosis. The rise in competitive youth sports has brought increased public attention to this injury. Meyers and McKeever Type II fractures are displaced anteriorly with an intact posterior hinge. This specific subtype of pediatric tibial spine fractures has controversy in the literature whether they should be treated non-operatively or operatively. The purpose of this study was to identify assess for variability amongst pediatric orthopaedic surgeons when treating pediatric type II tibial spine fractures. Methods: A discrete choice experiment was conducted to determine the patient and injury attributes that influence the management of type II pediatric tibial spine fractures by pediatric orthopaedic surgeons. A convenience sample of 14 pediatric orthopaedic surgeons reviewed 40 case vignettes (Figure 1) that included radiographs displaying fractures with varying degrees of displacement (range: 2.5 – 6.0 mm) and a brief description on the patient’s sex, age (8-17), mechanism of injury (fall, collision, hypertension, twist), and predominant sport (swimming, football, basketball, nonathlete). Surgeons were asked whether they would treat the fracture operatively or non-operatively. Physes were blinded. A mixed effects model was used to determine the patient attributes most likely to influence the surgeon’s decision for operative treatment of a tibial spine fracture. In addition, the association between surgeon propensity for operative treatment based on surgeon training, years in practice, and risk-taking behavior based on the Jackson Personality Inventory subscale was assessed. A receiver operating characteristic curve was used to determine probability of surgical treatment based on the degree of fracture displacement. Results: Surgeon demographics are summarized in Table 1. Overall, the 14 respondents selected operative treatment in 75% of the presented cases. The degree of fracture displacement was the only patient attribute that was significantly associated with treatment choice (p<0.001). Surgeons were 29% more likely to treat the fracture operatively with each additional millimeter of displacement. The probability of opting for surgical treatment exceeded 50% when the fracture had 3.5 or more millimeters of displacement. Significant variation in surgeon’s propensity for operative treatment of this fracture was observed (p=0.01). Nine of the 14 surgeons demonstrated a significant propensity for operative treatment of this injury. Surgeon training, years in practice, and risk-taking scores were not associated with the respondent’s preference for surgical treatment. Conclusions / Significance: There is substantial variation among pediatric orthopaedic surgeons when treating type II tibial spine fractures. The decision to operate is significantly based on the degree of fracture displacement. However, there is no standardization regarding how to treat type II tibial spine fractures and therefore better treatment algorithms are needed to optimize patient outcomes. Learning about the current treatment preferences among surgeons given different patient factors can highlight current variation in practice patterns and direct efforts toward promoting the most optimal treatment strategies. [Table: see text]

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Physician treatment preferences in non-displaced distal fibula fractures

Foot & Ankle Orthopaedics ◽

10.1177/2473011418s00366 ◽

2018 ◽

Vol 3 (3) ◽

pp. 2473011418S0036

Author(s):

Steven Neufeld ◽

Dan Merenstein

Keyword(s):

Operative Treatment ◽

Practice Guidelines ◽

Evidence Based Practice ◽

Operative Management ◽

The United States ◽

Nonoperative Treatment ◽

Treatment Preferences ◽

Evidence Based ◽

Foot And Ankle ◽

Orthopedic Surgeons

Category: Trauma Introduction/Purpose: Background: Several studies have demonstrated equivocal long-term functional outcomes for both operative and nonoperative treatment of Weber-B fractures, however there are currently no evidence-based practice guidelines. The purpose of this study was to determine which treatment modality was preferred by orthopedic surgeons in the United States and Internationally, despite the lack of accepted guidelines. Methods: Methods: A survey of 428 practicing orthopedic surgeons was conducted to evaluate physician treatment preferences for non-displaced Weber-B fractures. Analyses were performed to determine physician preference for operative versus nonoperative fracture treatment, as well as to determine group differences between U.S, international and foot and ankle orthopedic surgeons compared to all other orthopedic surgeons. A cost effective analysis was conducted to compare differences among nonoperative and operative preferences. Results: Nonoperative treatment of non-displaced Weber-B fractures was preferred by 90.4% of orthopedic surgeons compared to operative treatment (9.6%; P<0.0001). Internationally-based orthopedic surgeons chose operative management at a higher rate (30/129) than U.S.-based surgeons (11/299; P<0.0001). General orthopedic surgeons were not more likely than subspecialty orthopedic surgeons to choose operative management, but foot and ankle subspecialists chose operative treatment at a higher rate compared to all other orthopedic surgeons (11/61 versus 29/362; P=0.0185). The direct medical costs and the indirect societal costs are likely to be 249 percent greater if managed operatively. Conclusion: Our findings suggest that while the vast majority of practicing surgeons choose to non-operatively manage non-displaced Weber-B fractures, there still exist a significant percentage of physicians who prefer to operate on these fractures. Given the existing literature suggesting equivalent outcomes for operatively and non-operatively treated Weber-B fractures, the current data suggests the need for further research into the reasons behind such differences in treatment preferences, as well as the evolution of evidence-based practice guidelines to guide the management of this very common fracture.

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Prospective, Multicenter Assessment of Nonoperative Treatment Outcomes and Conversion to Operative Treatment for Adult Spinal Deformity: Minimum Two-Year Follow-Up

The Spine Journal ◽

10.1016/j.spinee.2014.08.250 ◽

2014 ◽

Vol 14 (11) ◽

pp. S98-S99

Author(s):

Justin S. Smith ◽

Christopher I. Shaffrey ◽

Virginie Lafage ◽

Frank J. Schwab ◽

Themistocles S. Protopsaltis ◽

...

Keyword(s):

Treatment Outcomes ◽

Operative Treatment ◽

Spinal Deformity ◽

Adult Spinal Deformity ◽

Nonoperative Treatment

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Pediatric Type II Tibial Spine Fractures: Addressing the Treatment Controversy With a Mixed-Effects Model

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967119866162 ◽

2019 ◽

Vol 7 (8) ◽

pp. 232596711986616

Author(s):

Alexander J. Adams ◽

Nathan N. O’Hara ◽

Joshua M. Abzug ◽

Julien T. Aoyama ◽

Theodore J. Ganley ◽

...

Keyword(s):

Operative Treatment ◽

Risk Taking ◽

Mixed Effects ◽

Spine Fractures ◽

Type Ii ◽

Fracture Fragment ◽

Orthopaedic Surgeons ◽

Tibial Spine ◽

Surgeon Training ◽

Pediatric Orthopaedic

Background: Tibial spine fractures, although relatively rare, account for a substantial proportion of pediatric knee injuries with effusions and can have significant complications. Meyers and McKeever type II fractures are displaced anteriorly with an intact posterior hinge. Whether this subtype of pediatric tibial spine fracture should be treated operatively or nonoperatively remains controversial. Surgical delay is associated with an increased risk of arthrofibrosis; thus, prompt treatment decision making is imperative. Purpose: To assess for variability among pediatric orthopaedic surgeons when treating pediatric type II tibial spine fractures. Study Design: Cross-sectional study. Methods: A discrete choice experiment was conducted to determine the patient and injury attributes that influence the management choice. A convenience sample of 20 pediatric orthopaedic surgeons reviewed 40 case vignettes, including physis-blinded radiographs displaying displaced fractures and a description of the patient’s sex, age, mechanism of injury, and predominant sport. Surgeons were asked whether they would treat the fracture operatively or nonoperatively. A mixed-effects model was then used to determine the patient attributes most likely to influence the surgeon’s decision, as well as surgeon training background, years in practice, and risk-taking behavior. Results: The majority of respondents selected operative treatment for 85% of the presented cases. The degree of fracture displacement was the only attribute significantly associated with treatment choice ( P < .001). Surgeons were 28% more likely to treat the fracture operatively with each additional millimeter of displacement of fracture fragment. Over 64% of surgeons chose to treat operatively when the fracture fragment was displaced by ≥3.5 mm. Significant variation in surgeon’s propensity for operative treatment of this fracture was observed ( P = .01). Surgeon training, years in practice, and risk-taking scores were not associated with the respondent’s preference for surgical treatment. Conclusion: There was substantial variation among pediatric orthopaedic surgeons when treating type II tibial spine fractures. The decision to operate was based on the degree of fracture displacement. Identifying current treatment preferences among surgeons given different patient factors can highlight current variation in practice patterns and direct efforts toward promoting the most optimal treatment strategies for controversial type II tibial spine fractures.

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Operative vs. Nonoperative Treatment of Intra-Articular Fractures of the Calcaneus: A Prospective Randomized Trial

Foot & Ankle International ◽

10.1177/107110079601700102 ◽

1996 ◽

Vol 17 (1) ◽

pp. 2-9 ◽

Cited By ~ 258

Author(s):

David B. Thordarson ◽

Lauren Eric Krieger

Keyword(s):

Randomized Trial ◽

Operative Treatment ◽

Excellent Result ◽

Early Mobilization ◽

Nonoperative Treatment ◽

Prospective Randomized Trial ◽

Functional Score ◽

Articular Fractures ◽

Nonoperative Group

Thirty patients with displaced, intra-articular calcaneus fractures were randomized to operative or nonoperative treatment. All patients had two or three major articular fragments of the posterior facet (Sanders type II or III). Nonoperative treatment included early mobilization and delayed weightbearing. Operative treatment involved open reduction and rigid internal fixation with a plate and screws through an extensile, L-shaped lateral approach followed by early mobilization and delayed weightbearing. Fifteen operative patients were evaluated at an average of 17 months follow-up and 11 nonoperative patients were seen at 14 months average follow-up. In the operative group, there were 7 excellent results, 5 good results, 2 fair results, and 1 poor result, and in the nonoperative group there was 1 excellent result, 3 good results, 1 fair result, and 6 poor results (difference significant at P < 0.01). A functional scoring system of 0–100 points was developed based upon the responses to an outcome assessment questionnaire. The average functional score for the operative group was far superior at 86.7, compared with 55.0 for the nonoperative group ( P < 0.0001). Subtalar range of motion averaged 20° for the operative group and 17° for the nonoperative group with pain on extremes of motion of 25% of the operative patients compared with 100% of the nonoperative patients. This study is the first prospective, randomized trial to demonstrate the superior results of current operative treatment with early mobilization compared with nonoperative treatment.

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Treatment of Pectoralis Major Tendon Tears: A Systematic Review and Meta-analysis of Operative and Nonoperative Treatment

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967119900813 ◽

2020 ◽

Vol 8 (2) ◽

pp. 232596711990081

Author(s):

Blake M. Bodendorfer ◽

Brian P. McCormick ◽

David X. Wang ◽

Austin M. Looney ◽

Christine M. Conroy ◽

...

Keyword(s):

Systematic Review ◽

Operative Treatment ◽

Mixed Model ◽

Meta Analysis ◽

Random Effect ◽

Nonoperative Treatment ◽

Pectoralis Major ◽

Isokinetic Strength ◽

Tendon Tears

Background: The incidence of pectoralis major tendon tears is increasing, and repair is generally considered; however, a paucity of comparative data are available to demonstrate the superiority of operative treatment. Purpose/Hypothesis: The purpose of this study is to compare the outcomes of operative and nonoperative treatment of pectoralis major tendon tears. We hypothesized that repair would result in superior outcomes compared with nonoperative treatment. Methods: In accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a systematic review of the literature was completed by use of MEDLINE, SPORTDiscus, CINAHL, Cochrane, EMBASE, and Web of Science databases. We included English-language studies that had a minimum of 6 months of average follow-up and 5 cases per study. The MINORS (Methodological Index for Non-Randomized Studies) was used to assess the quality of the existing literature. Meta-analysis of pooled mechanisms of injury and outcomes was completed. Pooled effect sizes were calculated from random-effects models. Continuous variables were assessed by use of mixed-model analysis, with the individual study designated as a random effect and the desired treatment for comparison as a fixed effect. Bivariate frequency data were transformed via the Freeman-Tukey log-linear transformation for variance stabilization and then assessed through use of a mixed model with a study level random effect and subsequently back-transformed. Significance was set at P < .05. Results: A total of 23 articles with 664 injuries met the inclusion criteria for comparison. All patients were male, with an average age of 31.48 years; 63.2% of injuries occurred during weight training, and the average follow-up was 37.02 months. Included studies had moderately high methodological quality. Operative treatment was significantly superior to nonoperative treatment, with relative improvements of functional outcome by 23.33% (0.70 improvement by Bak criteria which is scored 1-4; P = .027), full isometric strength 77.07% ( P < .001), isokinetic strength 28.86% ( P < .001) compared with the uninjured arm, cosmesis satisfaction 13.79% ( P = .037), and resting deformity 98.85% ( P < .001). The overall complication rate for operative treatment was 14.21%, including a 3.08% rate of rerupture. Conclusion: Pectoralis major tendon repair resulted in significantly superior outcomes compared with nonoperative treatment, with an associated 14.21% complication rate. Statistically significant improvements were noted in functional outcome, isokinetic strength, isometric strength, cosmesis, and resting deformity.

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A 5-Year Follow-up of Patients Treated for Full-Thickness Rotator Cuff Tears: A Prospective Cohort Study

Orthopaedic Journal of Sports Medicine ◽

10.1177/23259671211021589 ◽

2021 ◽

Vol 9 (9) ◽

pp. 232596712110215

Author(s):

Joel Gagnier ◽

Asheesh Bedi ◽

James Carpenter ◽

Christopher Robbins ◽

Bruce Miller

Keyword(s):

Cohort Study ◽

Rotator Cuff ◽

Operative Treatment ◽

Nonoperative Management ◽

Nonoperative Treatment ◽

Rotator Cuff Tears ◽

Symptom Duration ◽

Full Thickness ◽

Diabetes Status

Background: The evidence in support of operative versus nonoperative management of rotator cuff tears (RCTs) is limited, based primarily on observational studies of lower scientific merit. Purpose: To (1) compare the efficacy of operative versus nonoperative management of full-thickness RCTs across time and (2) detect variables that predict success within each group. Study Design: Cohort study; Level of evidence, 2. Methods: We included patients with symptomatic full-thickness RCTs who were enrolled in an institutional shoulder registry. Patient enrollment began in 2009 and continued until early 2018. The following outcome measures were collected at baseline, then 6 months, 1 year, and annually up to 5 years postoperatively: Western Ontario Rotator Cuff Index (WORC), American Shoulder and Elbow Surgeons (ASES) score, Veterans RAND 12-Item Health Survey (VR-12) mental and physical component subscales (MCS and PCS, respectively), 100-point Single Assessment Numeric Evaluation (SANE) rating, and 100-point visual analog scale (VAS) for pain and for patient satisfaction. We performed regression models for all outcome variables across all 5 years of follow-up and included the following predictor variables: treatment type (operative vs nonoperative), sex, age, symptom duration, smoking status, diabetes status, injury side, and obesity status. Results: A total of 595 patients were included. Longitudinal mixed-effects regression revealed that patients who received operative treatment did better across time on all outcomes. Women (n = 242; 40.7%) did not fare as well as did men on the ASES, WORC, or VR-12 PCS. Older patients tended to improve less on the VR-12 PCS and more on the VR12-MCS. Patients with longer symptom duration at baseline had better scores across time on the ASES, WORC, VAS for pain, and SANE. Current or recent smokers and patients with diabetes tended to have lower scores on all measures across time. For changes in scores from baseline, patients in the operative group improved to a larger degree out to 3 years compared with those in the nonoperative group. Conclusion: Patients with RCTs tended to improve regardless of whether they received operative or nonoperative treatment, but patients who underwent operative treatment improved faster. There appear to be several predictors of improved and worsened outcomes for patients with RCTs undergoing operative or nonoperative treatment.

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Outcomes and mortality after hip fractures treated in Kazakhstan

Hip International ◽

10.1177/1120700018773395 ◽

2018 ◽

Vol 28 (2) ◽

pp. 205-209 ◽

Cited By ~ 3

Author(s):

Sultan Amrayev ◽

Ussama AbuJazar ◽

Justinas Stucinskas ◽

Alfredas Smailys ◽

Sarunas Tarasevicius

Keyword(s):

Hip Fracture ◽

Operative Treatment ◽

Hip Fractures ◽

Western Europe ◽

Nonoperative Treatment ◽

Fracture Register ◽

Hip Function ◽

Patient Groups ◽

Nonoperated Group

Introduction: Patients with hip fractures are usually treated operatively in Western Europe. However, in Mid-Asia different indications are used to decide whether this patient is suitable for operative treatment and those are related to specific traditions and rules in hospital. Thus, traditions and surgeon/patient fears seem to affect treatment choices in hip fractures and subsequent outcomes. The aim of our study was to investigate patients with hip fractures and compare outcome at 1-year follow-up in the operated and nonoperated patient groups. Methods: All patients over 50 years old who sustained a hip fracture, between January 2014 and December 2014, were included. Patients were assessed preoperatively and at 1-year follow-up, using questionnaires from National Swedish Hip Fracture Register and quality of life (Euroqol EQ-5D). Results: Out of 398 included patients, 299 were operated on and 99 were not. 344 patients remained for our analysis before the end of 1-year follow-up. 51 patients (65%) deceased in the nonoperated group as compared to 55 (21%) in the operated group, p<0.001. Out of 27 patients in the nonoperated group hip function was evaluated at 1-year follow-up, 11 (41%) were walking independently or using 1 stick, as compared to 192 (91%) in the operated group. Conclusions: We conclude that nonoperative treatment of hip fracture patients is associated with higher mortality and worse functional outcome as compared to those who were treated operatively. We therefore advocate operative treatment of the hip fracture in the vast majority of cases.

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Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis at 5-year follow-up: durability of outcomes and impact of treatment-related serious adverse events

Journal of Neurosurgery Spine ◽

10.3171/2020.9.spine201472 ◽

2021 ◽

pp. 1-13

Author(s):

Justin S. Smith ◽

Michael P. Kelly ◽

Elizabeth L. Yanik ◽

Christine R. Baldus ◽

Thomas J. Buell ◽

...

Keyword(s):

Adverse Events ◽

Operative Treatment ◽

Nonoperative Treatment ◽

Incidence Rates ◽

Mean Difference ◽

Patient Counseling ◽

Serious Adverse Events ◽

Lumbar Scoliosis ◽

The Impact

OBJECTIVE Although short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes. METHODS The ASLS-1 (Adult Symptomatic Lumbar Scoliosis–1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40–80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]–22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22. RESULTS The 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference −15.2 [95% CI −18.7 to −11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48–0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI −13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2–5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI −12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE −8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD. CONCLUSIONS The significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.

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