How Can You Ensure That Your Assessment of Collected Data Is Valid?ã¢â‚¬â€¹

Introduction

Slipped majuscule femoral epiphysis (SCFE) is classified as unstable when the patient reports a level of pain that, regardless of the duration of the symptoms, is severe plenty to prevent walking even with crutches [¹⁶]. Instability of the SCFE has been cited as an important prognostic gene as a result of its association with the development of osteonecrosis of the femoral head [^sixteen ^, ¹⁷ ^, ^27-29]. Osteonecrosis is the virtually astringent complication later on unstable SCFE handling. Although previous studies [¹⁰ ^, ^sixteen ^, ¹⁷ ^, ¹⁹ ^, ²⁰ ^, ²³ ^, ^27-29] vary widely in terms of the proportion of patients who develop osteonecrosis after unstable SCFE, a contempo systematic review of the literature reported an overall charge per unit of 24% [²⁹]. Osteonecrosis leads to femoral caput collapse and farther hip osteoarthritis, and it is the near mutual indication for hip arthroplasty in patients with SCFE [¹¹ ^, ¹²].

Several surgical techniques including in situ pinning [¹⁹ ^, ²⁷], reduction with a decompression arthrotomy and pinning [¹ ^, ^{half dozen}], and open reduction [²⁰] have been described for the treatment of unstable SCFE. The recently described surgical dislocation approach [⁴] with autopsy of the retinacular flap containing the nutrient vessels to the femoral caput [^v] has immune for advances in the surgical treatment of SCFE using a modification of the Dunn [³] subcapital realignment procedure, in which open up realignment of the femoral epiphysis is performed. One of the benefits of the subcapital realignment through the surgical dislocation approach (modified Dunn process) is visualization and protection of the vascular retinaculum and direct assessment of perfusion of the femoral head during surgery. Femoral caput perfusion may exist assessed by evaluating bleeding later creating a 2-mm drill hole [^ix ^, ²⁴ ^, ³⁰ ^, ³¹], by laser-Doppler flowmetry [⁹ ^, ^thirty], and/or by intracranial pressure probe monitoring [²⁴]. Cess of perfusion during surgery may allow for adjustments of positioning the femoral head if blood flow decreases after the femoral head is reduced. In addition, it may allow for identification of patients at risk of developing osteonecrosis long before femoral head deformity develops, which would allow for potential early on interventions to foreclose such deformities. Although normally performed, the accuracy of femoral caput perfusion assessment during modified Dunn in unstable SCFE has not been well documented.

In this retrospective study we asked (1) whether intraoperative assessment of femoral head perfusion would help identify hips at risk of developing osteonecrosis; (two) whether i of the four methods of assessment of femoral head perfusion is more accurate (highest expanse under the curve) at identifying hips at risk of osteonecrosis; and (three) whether specific clinical features would be associated with osteonecrosis occurrence after a modified Dunn procedure for unstable SCFE.

Patients and Methods

In March 2007 nosotros began performing the modified Dunn procedure for handling of patients with an unstable SCFE as defined by the Loder [^xv]. Since 2011, we treated all patients with unstable SCFE with the modified Dunn procedure. Betwixt March 2007 and 2014, we performed 29 modified Dunn procedures for unstable SCFE in 16 boys and eleven girls with a median age of 13 (range, eight-17 years). During the study menstruation, 6 patients were treated by in situ pinning based on the indication by the orthopaedic surgeon on-call. Two patients who were lost to followup before 1 year were excluded from the study, leaving 27 patients followed for a minimum of i yr. Because osteonecrosis after unstable SCFE typically develops within the first twelvemonth of surgery [¹⁵ ^, ¹⁶ ^, ²⁴], we set up minimum followup of this study to 1 year. The median duration of followup was 2.5 years (range, 1-8 years).

I of the authors (LAK) retrospectively reviewed the medical records for collection of preoperative variables including age at surgery, sex, body mass index, estimated fourth dimension from injury to surgery, and SCFE chronicity. Severity of SCFE was assessed on AP pelvic preoperative radiographs and on frog-leg view radiographs when available [²⁶]. Intraoperative notes were reviewed for the purpose of assessing femoral head haemorrhage and harm to the periosteum and retinacular vessels and determining the type of fixation used.

Surgical treatment was performed past ane of the three senior authors (ENN, TCH, ELS) following a previously described technique [^xiii ^, ^xiv ^, ³¹]. 10 of the 27 patients (37%) were operated less than 24 hours afterwards the slip, whereas 17 of 27 (63%) were operated on 24 hours after the sideslip. Briefly, the patient was positioned in lateral decubitus and a straight lateral incision was performed. The fascia lata is incised anteriorly to the gluteus maximus to avert splitting the muscle. A trochanteric osteotomy was performed and the hip capsule was exposed. Afterwards capsulotomy, the metaphysis of the proximal femur was exposed and two-threaded Kirschner wires were used to provisionally stabilize the epiphysis. Before dissection of the retinacular flap, femoral head perfusion was assessed past drilling a two-mm hole in the anterosuperior attribute. The presence or absence of active bleeding was recorded (Fig. 1). An Integra^® Camino^® Intracranial Pressure Monitoring (Integra, Plainsboro, NJ, United states) display was adjusted to read nil and the intracranial pressure (ICP) probe was inserted into the drill hole. The scale of pressure waveform on the display was adapted to the range of −5 mmHg to 10 mmHg. Although the intracranial pressure (ICP) monitor displays a numeric value of pressure, the waveform was recorded as present when there was a large waveform with a clear elevation. The ICP monitor reading was interpreted equally negative when there was a apartment line with no clear waveform on display or in patients with very minimal wave changes on the display.

F1-17 — Fig. one:
Intraoperative moving-picture show during a modified Dunn procedure after definitive fixation of the epiphysis shows the presences of active haemorrhage through a 2-mm drill hole (pointer) and the intact vascular retinaculum (*).

The hip was then confused after release of the teres ligament past flexion and external rotation. The acetabular cartilage and labrum were assessed and the hip was reduced. An osteotomy was performed at the physis of the greater trochanter for subperiosteal dissection of the retinacular flap [⁵]. The retinaculum was dissected all the way posteriorly and after the hip was once again dislocated and the femoral neck was subperiosteally exposed anteriorly and medially. Posterior and inferior callus was resected; however, formal femoral neck shortening was avoided. After the epiphysis was curetted to remove the physeal cartilage, the epiphysis was reduced advisedly into the femoral neck and the alignment and tension to the retinaculum were checked. The epiphysis was so provisionally fixed with two threaded Kirschner wires or with the guidewires for a cannulated screw. The femoral head was reduced in the acetabulum and the epiphyseal bleeding was reassessed. In cases in which the perfusion of the femoral head was found to be absent or reduced, the tension on the retinaculum was checked and if necessary the femoral neck was shortened slightly not to exceed iii mm. Radiographic alignment of the epiphysis was confirmed and final fixation was obtained with three threaded Kirschner wires or ii cannulated six.5-mm screws, co-ordinate to surgeon preference. Final femoral head active bleeding and ICP monitor waveform were recorded with the hip in neutral position of abduction and rotation. The sheathing was loosely airtight. The trochanteric fragment was fixed with either 2 or three three.5-mm or 4.5-mm screws using a standard compression technique. The wound was airtight in layers. Patients were advised to avoid bearing weight and immune to use the contralateral leg for pivoting transfer in a wheelchair for minimum of 6 weeks. After this period, when radiographic healing was observed, patients were instructed to follow physical therapy-guided rehabilitation to achieve full bearing of weight.

1 of the authors (JCMA) assessed postoperative radiographs for the presence of osteonecrosis of the femoral head. Osteonecrosis was defined equally observations of changes in the femoral head including progressive sclerosis followed past cystic changes and plummet. Patients were typically evaluated clinically and with an AP and frog-leg radiograph at six and 12 weeks after surgery then at 6 months, 9 months, and at minimum 12 months postoperatively. Seven of the 27 patients (26%; exact 95% confidence interval, 11%-46%) developed osteonecrosis of the femoral caput. The diagnosis was made at a median of 3 months later surgery (range, ii-sixteen months). All patients who developed osteonecrosis were diagnosed during the first 6 months after surgery with the exception of one patient. A 12-year-one-time girl was seen at the iii-calendar month followup and was instructed to return for the 6-month postoperative visit. Still, equally a result of social issues, the patient was not seen until 409 days after surgery when she was seen with a major limp, pain, hip contracture, and complete resorption of the femoral head on radiographs. Among the seven patients who developed osteonecrosis, 2 had a complete tear of the retinaculum with nearly full avulsion from the epiphysis observed during surgery. These patients had absent perfusion of the femoral caput throughout the unabridged process.

All patients undergoing the modified Dunn process underwent assessment of epiphyseal perfusion by the presence of active bleeding and/or by ICP probe monitoring. Given the retrospective nature of the written report, in the initial five patients in this series, perfusion was recorded once, either before dissection of the retinacular flap or afterwards fixation by one of the two methods. In the remaining 22 patients (81%), perfusion was systematically assessed earlier dissection of the retinacular flap and later on fixation by both methods.

For the purpose of this study, femoral head perfusion was defined by the presence (negative exam) or absence (positive examination) of a waveform on the ICP monitor display and the presence (negative test) or absence (positive test) of active bleeding before the subperiosteal dissection of the retinaculum and after definitive fixation of the epiphysis. Measures of diagnostic accuracy including sensitivity, specificity, and the expanse under the receiver operating curve (AUC) along with their respective 95% confidence intervals were estimated for each method of detecting osteonecrosis. Amid patients who truly develop osteonecrosis, sensitivity represents the probability a given test is positive. Among patients who truly do not develop osteonecrosis, specificity represents the probability a given test is negative. A receiver operating curve (ROC curve) is constructed graphically by plotting the sensitivity on the Y-axis and 1-specificity on the X centrality. The expanse under the curve represents the total expanse nether the ROC curve and describes the accuracy of a exam. Values range between 0 and 1 with higher values indicative of better exam functioning. Values of 0.five suggest the test is equivalent to random run a risk at differentiating between patients who do versus do not develop osteonecrosis. Generally, AUC values tin can exist interpreted every bit the probability that amid a given pair of patients (one with osteonecrosis and one without), the test volition correctly identify the patient with osteonecrosis [^seven]. When comparing test options, the examination associated with the higher AUC value is generally considered a superior test [²²].

Multivariable logistic regression models (Proc Logistic; SAS 9.iv, Cary, NC, U.s.a.) were used to test the null hypothesis that the AUC values obtained from the models representing each of the four methods of assessing perfusion condition were ≤ 0.l. The nonparametric methods described by DeLong et al. [ⁱⁱ] were used to test for difference in AUC beyond the four methods. Based on the distribution of body mass alphabetize (BMI) across subjects who did versus did not develop osteonecrosis, all models included BMI as a cofounding variable. A secondary analysis investigated potential factors associated with osteonecrosis. Descriptive statistics were used to summarize the demographics and clinical characteristics of subjects who did versus did not develop osteonecrosis after the surgical direction of an unstable SCFE. Wilcoxon rank-sum or Fisher'south exact test was used to compare the distribution of these variables across the two osteonecrosis groups.

Results

Later on adjusting for BMI, the cess of femoral head perfusion with ICP monitoring before retinaculum dissection (adjusted AUC: 0.79; 95% confidence interval [CI], 0.58-0.99; p = 0.006), the cess of femoral head perfusion with ICP monitoring after definitive fixation (adapted AUC: 0.82; 95% CI, 0.65-1.0; p < 0.001), the presence of femoral caput bleeding before retinaculum dissection (adapted AUC: 0.77; 95% CI, 0.58-0.96; p = 0.006), and the presence of femoral head haemorrhage afterward definitive fixation (adjusted AUC: 0.81; 95% CI, 0.63-0.99; p = 0.001) were superior to random run a risk at differentiating between patients who did versus did non develop osteonecrosis during the study menstruum.

There was no difference in AUC across the four methods of assessing femoral caput perfusion status (p = 0.8226). A descriptive review of the unadjusted measures of diagnostic accuracy revealed that assessment of active bleeding afterwards fixation had splendid (1.0; 95% CI, 0.82-1.0) specificity, whereas ICP monitoring before retinaculum dissection had practiced sensitivity (0.67; 95% CI, 0.22-0.96; Tabular array 1).

T1-17 — Tabular array 1:
Unadjusted measures of diagnostic accuracy associated with the four methods of assessing femoral caput perfusion

With the numbers available, nosotros found no clinical features that allowed us to predict which hips were at risk of developing osteonecrosis. The mean BMI of patients who did non progress to osteonecrosis was 25 kg/m² (SD 6), whereas the hateful BMI of patients who did was 30 kg/1000ⁱⁱ (SD 5) (p = 0.0818) (Table 2).

T2-17 — Table ii:
Comparison of patients who did versus did not develop osteonecrosis of the femoral head

Discussion

At that place has been a recent increase in interest of the modified Dunn procedure for the handling of SCFE [²⁴]. The increased attending is nearly likely related to the fact that osteonecrosis of the femoral head was not reported in the beginning descriptive studies [¹³ ^, ¹⁴ ^, ²⁹]. Recent studies, all the same, have reported that approximately 25% of patients undergoing a modified Dunn for unstable SCFE developed osteonecrosis [²¹ ^, ²²]. One of the advantages of the modified Dunn procedure is the ability to perform an intraoperative assessment of epiphyseal perfusion and controlled reduction of the epiphysis preserving its claret supply. Yet, at that place is limited evidence [^eighteen ^, ³⁰] about the performance of epiphyseal perfusion assessment in screening for osteonecrosis. In this report, we investigated the accuracy of intraoperative assessment of femoral caput vascularity by examining the presence of active haemorrhage and using an ICP monitor as an indicator for osteonecrosis development in patients undergoing a modified Dunn procedure for the treatment of unstable SCFE while assessing clinical features as possible prognostic factors. We found that after adjusting for BMI, all iv methods of assessing femoral head perfusion were superior to random chance at differentiating between patients who did versus did non have osteonecrosis by the end of the study period.

This study has several limitations. Kickoff, this was a retrospective study based on data collected from operative notes over a relatively long time. In the initial five patients in this series, perfusion was recorded once, either before dissection of the retinacular flap or subsequently fixation by one of the two methods. In the remaining 22 patients (81%), perfusion was systematically assessed earlier dissection of the retinacular flap and afterward fixation by both methods. Although this may have limited the number of patients with complete data, we do not believe that this compromises our findings because it reflects our evolution in assessing femoral head perfusion rather than a selective assessment. 2nd, our cohort represents the learning curve of the 3 surgeons. Thus, the overall proportion of patients who developed osteonecrosis may be higher than the expected proportion reported by the originators of the technique [¹³ ^, ¹⁴ ^, ²⁹]. Still, all surgeons were experienced in the surgical dislocation arroyo and the proportion of osteonecrosis in this series compares well to other recent studies [²⁴ ^, ²⁵]. We believe that by including multiple surgeons with relevant expertise, we improved the external validity of our written report. Third, the assessment of femoral head perfusion using the presence of active bleeding and ICP monitoring may be subjective. In agreement with a previous written report [⁶], we noted that during surgery, the quality of the femoral head bleeding after drilling was non necessarily homogeneous. In some patients, immediate bright red blood came out of the hole, whereas in others, the bleeding was darker and more than delayed. For the ICP monitoring, we did non use an objective assessment of the actual numeric value of the pressure because the device was not developed for intraosseous force per unit area monitoring. Nosotros nerveless the presence of an aplenty waveform versus an absent waveform. The few patients in whom minimal changes in the monitor brandish were seen were classified as having no waveform present. Quaternary, during the first 4 years of the study, six patients with unstable SCFE were treated by other methods, which could heighten a business concern for choice bias. Even so, the indication for treatment on these cases was solely based on the treating surgeon who was on call rather than on severity of the SCFE. Since 2011 all patients with unstable SCFE have been treated by the modified Dunn approach. Fifth, as a result of the small number of patients, our study was limited in power to find factors predictive of osteonecrosis. However, unstable SCFE is an uncommon condition and larger investigations involving multiple centers are needed to accumulate a large number of patients. Finally, the followup on this series of patients is relatively short, and because the series is small, information technology would not accept very many events in the test (+) grouping or the test (−) group for our conclusions to change, which reflects low statistical ability. However, our experience as well as that of other investigators [¹⁵ ^, ¹⁶ ^, ²⁴] is that the development of osteonecrosis afterwards SCFE occurs within the kickoff 12 months of treatment. In this serial, all patients who were diagnosed with osteonecrosis adult information technology inside a year of treatment.

We found that in combination with patients' characteristics, namely BMI, the 4 methods of assessing femoral head perfusion were constructive at differentiating between patients who practise versus do not develop osteonecrosis subsequently a modified Dunn procedure for unstable SCFE. The information gained from assessing femoral caput perfusion may be used to assistance the surgeon during and later on the procedure. For instance, if the femoral head is found to have perfusion before dissection of the retinaculum, it is expected that perfusion will be maintained throughout the procedure. If perfusion is lost after reduction and fixation, the surgeon may exist able to adjust the head realignment and position, potentially shorten the femoral neck slightly, or revisit the flap dissection to reestablish the blood flow. Another potential benefit of intraoperative assessment of perfusion is identification of patients at take a chance of developing osteonecrosis before radiographic changes have place, which may allow for early interventions to foreclose severe deformity secondary to epiphyseal collapse. Complete absence of epiphyseal perfusion (before dissection and after fixation) was highly indicative of osteonecrosis and this may be an indication for further treatment including intravenous bisphosphonates [²¹].

Our data did not favor one test over the other for assessment of femoral head perfusion during modified Dunn for unstable SCFE. Nonetheless, a descriptive analysis of the raw measurements of accuracy showed that ICP monitoring earlier dissection demonstrated good sensitivity, whereas haemorrhage after definitive fixation was a highly (100%) specific test. The absence of femoral head perfusion after fixation was too institute to accept high specificity by Madan et al. [¹⁸] who reported osteonecrosis in 4 our of 17 patients with unstable SCFE who had no bleeding earlier dislocation and after reduction. Similarly, Sankar et al. [²⁴] establish no perfusion subsequently fixation in three of 27 unstable SCFEs. All three patients developed osteonecrosis. However, in accordance with Ziebarth et al. [^xxx], we observed two patients with an intact retinacular flap in whom in that location was no intraoperative ICP waveform and who did not development of osteonecrosis. These represent examples of a false-positive test consequence. Information technology is unclear, however, whether revascularization was related to the integrity of the retinacular vessels or if information technology may have happened through a transphyseal machinery. Contrary to previous studies [⁹ ^, ¹⁸ ^, ³⁰], we constitute three patients with an ICP waveform before autopsy and after fixation who subsequently developed osteonecrosis. These represent examples of a false-negative test result. In two patients, the femoral head was well perfused at baseline and it is possible that osteonecrosis developed in association with tension of the sheathing closure. This, however, was also reported past Sankar et al. [²⁴] who found iv patients who developed osteonecrosis despite confirmed blood flow later on fixation. Continuing with monitoring toward the end of the procedure, although technically challenging, may let for identification of cases that lose claret supply after closure of the capsule.

With the numbers available, we were non able to identify any factors related to osteonecrosis of the femoral caput after a modified Dunn process for unstable SCFE. Like to Sankar et al. [²⁴], we did not identify timing to surgery equally a factor. This may be related to the fact that we did not perform whatever surgery inside eight hours afterwards presentation. In contrast, Ziebarth et al. [^xxx] showed that patients undergoing a modified Dunn process less than 8 hours from injury were less probable to develop osteonecrosis when compared with patients undergoing surgery after 8 hours. Early surgery may have the do good of decompression of the hematoma, which has been associated with increased intraarticular pressure, a potential risk factor for osteonecrosis [⁸]. Although the etiology of osteonecrosis later on unstable SCFE remains controversial, our data confirmed traumatic rupture of the retinaculum as an unusual mechanism.

The modified Dunn procedure allows for controlled visualization and protection of the vascular retinaculum and assessment of the claret catamenia to the femoral head during surgery. Our findings suggested that assessment of femoral head active haemorrhage or ICP monitoring is effective in identifying patients who are at high adventure of developing osteonecrosis when they are used in combination with patient specific factors such equally BMI. In do the treating surgeon should carefully consider whether it is preferable to rely on a test with high sensitivity (ICP monitoring earlier retinacular autopsy) to minimize the number of false-negatives or if it is preferable to choose a test with high specificity (cess of active bleeding after fixation) to minimize the number of false-positives and overtreatment. Considering osteonecrosis is a severe complication of unstable SCFE with a high risk of progressive hip degenerative osteoarthritis [¹²], nosotros believe that utilise of a exam with high sensitivity is preferable, because it would include all patients who would develop osteonecrosis. In our study, total lack of blood menstruation earlier dissection and after fixation was highly indicative of risk of necrosis. This finding may thus be an indication for farther intervention.

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