The Philosophy of Surgical Success and Outcomes of Cartiva Versus Fusion.

Noninferiority studies in surgery are, by their very nature, reductionist. They use multiple variables to generate a yes or no answer about the new device being tested. A binary outcome is appropriate for a regulatory agency such as the Food and Drug Administration, but the clinical situation is more nuanced. It is critical to understand the underlying philosophies and choices that go into trial design when a surgeon is recommending a new device. In the case of Cartiva, any of 3 reasonable alternative means of defining surgical success would have altered the final outcome of the MOTION trial. Additionally, using a more rigorous noninferiority margin rather than adding an additional cushion based upon the argument that motion alone had extra inherent value would have also led to failure of the trial to demonstrate noninferiority.

Lower Extremity Injury Rates on Artificial Turf Versus Natural Grass Playing Surfaces: A Systematic Review.

BACKGROUND: No study has provided a comprehensive systematic review of sports injuries on artificial turf versus natural grass. PURPOSE: To comprehensively examine the risk of overall injuries and multiple types of lower extremity injuries across all sports, all levels of competition, and on both old-generation and new-generation artificial turf. STUDY DESIGN: Systematic review; Level of evidence, 3. METHODS: A systematic review of the English-language literature was performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. All included articles compared overall injury rates or lower extremity (hip, knee, or foot and ankle) injury rates on artificial turf and natural grass. All sports, levels of competition, and turf types were included. Studies were excluded if they did not include overall injury rates or lower extremity injury rates. Because of the heterogeneity of the included studies, no attempt was made to aggregate risk ratios to conduct a quantitative meta-analysis. RESULTS: A total of 53 articles published between 1972 and 2020 were identified for study inclusion. Most studies on new-generation turf (13/18 articles) found similar overall injury rates between playing surfaces. When individual anatomic injury locations were analyzed, the greatest proportion of articles reported a higher foot and ankle injury rate on artificial turf compared with natural grass, both with old-generation (3/4 articles) and new-generation (9/19 articles) turf. Similar knee and hip injury rates were reported between playing surfaces for soccer athletes on new-generation turf, but football players, particularly those at high levels of competition, were more likely to sustain a knee injury on artificial turf than on natural grass. CONCLUSION: The available body of literature suggests a higher rate of foot and ankle injuries on artificial turf, both old-generation and new-generation turf, compared with natural grass. High-quality studies also suggest that the rates of knee injuries and hip injuries are similar between playing surfaces, although elite-level football athletes may be more predisposed to knee injuries on artificial turf compared with natural grass. Only a few articles in the literature reported a higher overall injury rate on natural grass compared with artificial turf, and all of these studies received financial support from the artificial turf industry.

Philosophies of Surgical Care Are Embedded in Outcome Studies: An Illustrative Reanalysis of the Cartiva MOTION Trial.

BACKGROUND: Subjective assumptions on the definition of surgical success are inherent to the design of clinical trials with a categorial outcome. The current study used reasonable alternative assumptions about surgical care to reassess data for the randomized controlled Cartiva trial (MOTION). METHODS: Data from the published study were augmented by publicly accessible internal US Food and Drug Administration documents. As in the published report, 1-sided lower bound 95% CIs (LBCI95) for the difference of proportions were calculated for a series of alternative scenarios in which the assumptions underlying what constitutes surgical success were altered. RESULTS: Using a noninferiority margin of -15%, the MOTION trial reported success based on a 1-sided LBCI95 of -10.9%. Each of the 3 independent alternative scenarios analyzed yielded results that altered the primary outcome of the trial: (1) eliminating failures based solely upon radiographs findings, thereby considering a painless pseudarthrosis as a success (1-sided LBCI95 of -15.9%), (2) considering only major surgical revision as a failure and discounting isolated hardware removal (1-sided LBCI95 of -15.1%), and (3) using a visual analog scale (VAS) pain threshold of <30 as the success criterion rather than a 30% reduction in VAS pain score (1-sided LBCI95 of -15.8%). CONCLUSION: In this reanalysis, applying any of 3 reasonable alternative assumptions about the definition of surgical success to the data resulted in failure to prove noninferiority of Cartiva over arthrodesis, a reversal of the reported trial result. These results highlight the effect of subjective assumptions in the design of clinical trials with a categorical outcome and illustrate how differing philosophies about what constitutes surgical success can be pivotal in determining the final result. LEVEL OF EVIDENCE: Level II, prospective comparative study.

What Is the Interrater and Intrarater Reliability of the Lawrence and Botte Classification System of Fifth Metatarsal Base Fractures?

BACKGROUND: Fractures of the proximal fifth metatarsal are common, and often they are classified using a three-part scale first proposed by Lawrence and Botte. A clear consensus on prognosis and treatment for these fractures is lacking, particularly for fractures in the middle classification, Zone 2; the reliability of the classification scheme itself may be partly at fault for this. The intra- and interrater reliability of the classification itself has never been established, and it remains unclear whether the three-part classification of fifth metatarsal fractures can be applied consistently enough to guide treatment. QUESTIONS/PURPOSES: When used by experienced orthopaedic surgeons, (1) What is the overall interrater reliability of the three-part Lawrence and Botte classification of fifth metatarsal base fractures? (2) What is the overall intrarater reliability of the three-part Lawrence and Botte classification of fifth metatarsal base fractures? (3) What are these same metrics for the individual transitions within the classification (Zone 1-2 and Zone 2-3)? METHODS: Thirty sets of initial presentation radiographs representing an equal number of fractures originally diagnosed by treating clinicians as Zone 1, Zone 2, and Zone 3 were evaluated and classified by three orthopaedic surgeons specializing in foot and ankle surgery and eight foot and ankle fellows to determine interrater reliability. Two weeks later, the same set of radiographs were reevaluated in random order to determine intrarater reliability. Kappa values for interrater and intrarater reliability were calculated. Additionally, the individual transitions between zones were separately analyzed by calculating kappa values for a hypothetical two-part classification based on each transition. RESULTS: The three-part Lawrence and Botte classification of fifth metatarsal fractures demonstrated an overall interrater agreement of κ = 0.66 (observed agreement 77% versus chance agreement 33%). Intrarater reliability for the 11 surgeons ranged from κ = 0.60 to κ = 0.90. A two-part scheme divided by the transition between Zone 1 and Zone 2 demonstrated an interrater agreement of κ = 0.83, and a two-part scheme divided by the transition between Zone 2 and Zone 3 demonstrated a much lower interrater reliability of κ = 0.66. CONCLUSION: The three-part Lawrence and Botte classification system demonstrated a concerningly low level of interrater reliability with an observed agreement of 77% compared with a chance agreement of 33%. The primary source of concern is the assessment of the interface between Zone 2 and Zone 3, which proved much less reliable than that between Zone 1 and Zone 2. This suggests that previous studies of isolated Zone 1 fractures likely contain a homogeneous fracture cohort, whereas studies of Zone 2 or Zone 3 fractures are likely to include a mixture of fracture types. In practice, the consensus treatment of fifth metatarsal fractures differs based on whether they represent a more proximal, avulsive injury or a more distal injury from indirect trauma. Our data suggest that the Lawrence and Botte classification should be abandoned. Further work should focus on developing a new classification scheme that demonstrates improved interobserver reliability and more directly corresponds to this treatment paradigm. LEVEL OF EVIDENCE: Level III, diagnostic study.

Is Arthrodesis Sufficient in the Setting of Complex, Severe and Rigid Progressive Collapsing Foot Deformities?

Arthrodesis of the hindfoot is typically used for the correction of severe and arthritic progressive collapsing foot deformity. Concomitant bony or soft tissue procedures may be helpful in patients with congenital abnormalities including the ball-and-socket ankle or congenital vertical talus. Dysplasia of the hindfoot bones may be more common than previously recognized, and corrective procedures or alterations in technique may need to be performed during hindfoot arthrodesis to account for bony deformity. Intraarticular osteotomies, extraarticular osteotomies, tendon lengthening, and tendon transfer procedures may be used in specific instances to aid in deformity correction and improve overall function.

Radiographic Outcomes of Cotton Osteotomy in Treatment of Adult-Acquired Flatfoot Deformity.

BACKGROUND: We investigated the long-term radiographic outcomes of the Cotton osteotomy performed at our institution by the 2 senior authors in conjunction with other reconstruction procedures to correct adult-acquired flatfoot deformity (AAFD). METHODS: We retrospectively studied patients who underwent Cotton osteotomy between 2005 and 2010 with minimum 4-year follow-up. Radiographic assessment was made on weightbearing radiographs taken at 4 different time intervals: preoperative, early (first postoperative full weightbearing), intermediate (between 1 and 4 years postoperatively), and final (over 4 years postoperatively). RESULTS: Nineteen patients were included. Final follow-up was 8.6 ± 2.6 years. The lateral talus-first metatarsal angle improved significantly from preoperative to early radiographs (n = 15; mean change: 30 degrees, 95% CI, 21.6-38.7; P < .0001). A significant loss of correction was observed between intermediate and final radiographs (n = 11; mean change: 17 degrees, 95% CI, 8.1-26.4; P < .0001). Of 14 patients with early radiographs, 8 lost >50% of the correction initially achieved. Medial column height decreased by 3.0 mm (95% CI, 1.80-7.90; P = .35) between early radiographs and final follow-up. DISCUSSION: This is the longest reported radiographic follow-up of the Cotton osteotomy performed to address forefoot varus deformity as part of AAFD. The Cotton osteotomy achieved radiographic correction of the medial longitudinal arch at early follow-up, but approximately half of the patients had lost over 50% of that correction at final follow-up. The lengthened angular shape of the cuneiform did not collapse, implying that further collapse occurred through the medial column joints. LEVEL OF EVIDENCE: Level IV, case series.