Scaphoid Length Loss Following Nonunion Is Associated with Dorsal Intercalated Segment Instability.

Background Dorsal intercalated segment instability (DISI) in scaphoid nonunions is frequently attributed to fracture location relative to ligamentous attachments onto the scaphoid apex. We hypothesize scaphoid length loss to have a stronger correlation with DISI deformity than fracture location in patients with scaphoid nonunion. Questions/Purposes To investigate the correlation between (1) scaphoid length loss, (2) fracture location relative to the scaphoid apex, and (3) type of nonunion (Herbert classification) and DISI deformity in skeletally mature patients with scaphoid nonunion. Patients and Methods Twenty-seven cases of computed tomography (CT)-confirmed scaphoid nonunion (>6 months) were retrospectively included. Our primary outcome was the degree of DISI as measured by the radiolunate (RL) angle on CT. Scaphoid length loss was expressed as height-to-length (H/L) ratio. Fracture location was classified as proximal or distal to the scaphoid apex. Nonunions were classified as fibrous unions (type D1) or pseudoarthrosis (type D2). The correlation between RL angle, H/L ratio, fracture location, and nonunion type was evaluated. Results H/L ratio was the only factor associated with the degree of DISI as measured by RL angle. As scaphoid length loss increased (increasing H/L ratio), the RL angle increased. There was no significant difference in RL angle between fractures located proximal (30 degrees) or distal (28 degrees) to the scaphoid apex, or type D1 (31 degrees) versus type D2 (28 degrees) nonunions. There was no correlation between patient age, sex, or wrist side affected and RL angle. Conclusions Scaphoid length loss, rather than fracture location, is correlated to the degree of DISI deformity in patients with scaphoid nonunion. This highlights the importance of restoring scaphoid height when planning scaphoid nonunion reconstruction. Level of Evidence Level III, diagnostic study.

Routine MRI Among Patients With a Suspected Scaphoid Fracture Risks Overdiagnosis.

BACKGROUND: In the setting of a suspected scaphoid fracture, MRI may result in overdiagnosis and potential overtreatment. This is in part because of the low prevalence of true fractures among suspected fractures, but also because of potentially misleading variations in signal that may be more common than fracture-related signal changes. To better understand the risk of overdiagnosis, we first need insight into the relative prevalence of useful and potentially distracting signal changes among patients with a suspected scaphoid fracture. QUESTION/PURPOSE: What is the proportion of signal changes representing definite and possible scaphoid fractures relative to other types of signal changes on MRI among patients with a suspected scaphoid fracture? METHODS: In a retrospective study in an orthopaedic trauma clinic associated with a Level I trauma center, we evaluated MR images of patients 16 years and older with a clinically suspected scaphoid fracture. At our institution, patients with symptoms and signs of a possible scaphoid fracture and negative radiographs undergo MRI scanning. Between January 1, 2012, and September 1, 2019, a total of 310 patients 16 years or older had an MRI to evaluate a suspected scaphoid fracture. Exclusion criteria included a scaphoid fracture that was visible on radiographs before MRI as reported by the radiologist (four patients), no available radiographs before MRI (two), MRI more than 3 weeks after injury (28), unknown date of injury (nine), and repeat or bilateral MRI scans (11), leaving 256 MR images for analysis. Sixty percent (153) of patients were women, and the median age was 34 years (IQR 21 to 50 years). The images were taken a median of 8 days (IQR 2 to 12 days) after injury. MR images were screened for the presence of scaphoid signal changes. We identified the following patterns of signal change with a reliability of kappa 0.62: definite scaphoid fracture, possible scaphoid fracture, signal in the waist area other than possible or definite fractures, and other signal changes. A definite scaphoid fracture was defined as a linear, focal, and bicortical signal abnormality, with adjacent edema and a relatively transverse orientation relative to the scaphoid long axis. The transverse linear signal was visible on more than one cut in multiple planes. A possible scaphoid fracture had a transverse linear signal on more than one cut on sagittal or coronal planes, with or without adjacent edema. RESULTS: Six percent (16 of 256) of MR images were categorized as revealing definite (2% [four of 256]) or possible (5% [12 of 256]) scaphoid fractures, whereas 29% (74 of 256) were categorized as revealing nonspecific signal changes at the waist (14% [35 of 256]) and other areas (15% [39 of 256]). Of the 51 patients with scaphoid waist signal changes, 69% (35) were categorized as having distracting and potentially misleading MRI findings. CONCLUSION: The high prevalence of signal changes that are distracting and potentially misleading, the low prevalence of signal changes that clearly represent a scaphoid fracture, and the low pretest odds of a true fracture among patients with a suspected scaphoid fracture illustrate that routine MRI of suspected scaphoid fractures carries a notable risk of overdiagnosis and potential overtreatment. Two alternative strategies are supported by preliminary evidence and merit additional attention: more-selective use of MRI in people deemed at higher risk according to a clinical prediction rule and strategies for involving the patient in decisions regarding how to manage the notably small risk of future symptomatic nonunion. LEVEL OF EVIDENCE: Level IV, diagnostic study.

A Machine Learning Algorithm to Estimate the Probability of a True Scaphoid Fracture After Wrist Trauma.

PURPOSE: To identify predictors of a true scaphoid fracture among patients with radial wrist pain following acute trauma, train 5 machine learning (ML) algorithms in predicting scaphoid fracture probability, and design a decision rule to initiate advanced imaging in high-risk patients. METHODS: Two prospective cohorts including 422 patients with radial wrist pain following wrist trauma were combined. There were 117 scaphoid fractures (28%) confirmed on computed tomography, magnetic resonance imaging, or radiographs. Eighteen fractures (15%) were occult. Predictors of a scaphoid fracture were identified among demographics, mechanism of injury and examination maneuvers. Five ML-algorithms were trained in calculating scaphoid fracture probability. ML-algorithms were assessed on ability to discriminate between patients with and without a fracture (area under the receiver operating characteristic curve), agreement between observed and predicted probabilities (calibration), and overall performance (Brier score). The best performing ML-algorithm was incorporated into a probability calculator. A decision rule was proposed to initiate advanced imaging among patients with negative radiographs. RESULTS: Pain over the scaphoid on ulnar deviation, sex, age, and mechanism of injury were most strongly associated with a true scaphoid fracture. The best performing ML-algorithm yielded an area under the receiver operating characteristic curve, calibration slope, intercept, and Brier score of 0.77, 0.84, -0.01 and 0.159, respectively. The ML-derived decision rule proposes to initiate advanced imaging in patients with radial-sided wrist pain, negative radiographs, and a fracture probability of ≥10%. When applied to our cohort, this would yield 100% sensitivity, 38% specificity, and would have reduced the number of patients undergoing advanced imaging by 36% without missing a fracture. CONCLUSIONS: The ML-algorithm accurately calculated scaphoid fracture probability based on scaphoid pain on ulnar deviation, sex, age, and mechanism of injury. The ML-decision rule may reduce the number of patients undergoing advanced imaging by a third with a small risk of missing a fracture. External validation is required before implementation. TYPE OF STUDY/LEVEL OF EVIDENCE: Diagnostic II.

The influence of fracture location and comminution on acute scaphoid fracture displacement: three-dimensional CT analysis.

We aimed to assess the influence of fracture location and comminution on acute scaphoid fracture displacement using three-dimensional CT. CT scans of 51 adults with an acute scaphoid fracture were included. Three-dimensional CT was used to assess fracture location, comminution and displacement. Fracture location was expressed as the height of the cortical breach on the volar and dorsal side of the scaphoid relative to total scaphoid length (%), corresponding to the fracture's entry and exit point, respectively. We found a near-linear relation between dorsal fracture location and displacement. As dorsal fracture location became more distal, translation (ulnar, proximal, volar) and angulation (flexion, pronation) of the distal fragment relative to the proximal fragment increased. Comminuted fractures had more displacement. Dorsal fracture location predictably dictates the direction of translation and angulation in displaced scaphoid fractures. Surgeon attention to dorsal fracture location can help identify displacement patterns and provide guidance in adequately reducing a displaced scaphoid fracture.Level of evidence: III.

Factors associated with surgeon recommendation for additional cast immobilization of a CT-verified nondisplaced scaphoid waist fracture.

INTRODUCTION: Data from clinical trials suggest that CT-confirmed nondisplaced scaphoid waist fractures heal with less than the conventional 8-12 weeks of immobilization. Barriers to adopting shorter immobilization times in clinical practice may include a strong influence of fracture tenderness and radiographic appearance on decision-making. This study aimed to investigate (1) the degree to which surgeons use fracture tenderness and radiographic appearance of union, among other factors, to decide whether or not to recommend additional cast immobilization after 8 or 12 weeks of immobilization; (2) identify surgeon factors associated with the decision to continue cast immobilization after 8 or 12 weeks. MATERIALS AND METHODS: In a survey-based study, 218 surgeons reviewed 16 patient scenarios of CT-confirmed nondisplaced waist fractures treated with cast immobilization for 8 or 12 weeks and recommended for or against additional cast immobilization. Clinical variables included patient sex, age, a description of radiographic fracture consolidation, fracture tenderness and duration of cast immobilization completed (8 versus 12 weeks). To assess the impact of clinical factors on recommendation to continue immobilization we calculated posterior probabilities and determined variable importance using a random forest algorithm. Multilevel logistic mixed regression analysis was used to identify surgeon characteristics associated with recommendation for additional cast immobilization. RESULTS: Unclear fracture healing on radiographs, fracture tenderness and 8 (versus 12) weeks of completed cast immobilization were the most important factors influencing surgeons' decision to recommend continued cast immobilization. Women surgeons (OR 2.96; 95% CI 1.28-6.81, p = 0.011), surgeons not specialized in orthopedic trauma, hand and wrist or shoulder and elbow surgery (categorized as 'other') (OR 2.64; 95% CI 1.31-5.33, p = 0.007) and surgeons practicing in the United States (OR 6.53, 95% CI 2.18-19.52, p = 0.01 versus Europe) were more likely to recommend continued immobilization. CONCLUSION: Adoption of shorter immobilization times for CT-confirmed nondisplaced scaphoid waist fractures may be hindered by surgeon attention to fracture tenderness and radiographic appearance.

Prospective Cohort Study to Investigate Factors Associated With Continued Immobilization of a Nondisplaced Scaphoid Waist Fracture.

PURPOSE: The decision to continue immobilization of a nondisplaced scaphoid waist fracture is often based on radiographic appearance (despite evidence that radiographs are unreliable and inaccurate for diagnosing scaphoid union 6-12 weeks after fracture) and fracture tenderness (even though it is influenced by cognitive biases on pain). This may result in unhelpful additional immobilization. We studied nondisplaced scaphoid waist fractures to determine the factors associated with (1) the surgeon's decision to continue cast or splint immobilization at the first visit when cast removal was being considered; (2) greater pain on examination; and (3) the surgeon's concern about radiographic consolidation. METHODS: We prospectively included 46 patients with a nondisplaced scaphoid waist fracture treated nonoperatively. At the first visit when cast removal was considered - after an average of 6 weeks of immobilization - patients rated pain during 4 examination maneuvers. The treating surgeon assessed union on radiographs and decided whether to continue or discontinue immobilization. Patients completed measures of the following: (1) the degree to which pain limits activities (Patient-Reported Outcome Measure Interactive System [PROMIS] Pain Interference Computer Adaptive Test [CAT], Pain Self-Efficacy Questionnaire-2); (2) symptoms of depression (PROMIS Depression CAT); and (3) upper extremity function (PROMIS Upper Extremity Function CAT). We used multivariable regression analysis to investigate the factors associated with each outcome. RESULTS: Perceived inadequate radiographic healing and greater symptoms of depression were independently associated with continued immobilization. Pain during the examination was not associated with continued immobilization. Patient age was associated with pain on examination. Shorter immobilization duration was the only factor associated with the surgeon's perception of inadequate radiographic consolidation. CONCLUSIONS: Inadequate radiographic healing and greater symptoms of depression are associated with a surgeon's decision to continue cast or splint immobilization of a nondisplaced scaphoid waist fracture. CLINICAL RELEVANCE: Overreliance on radiographs and inadequate accounting for psychological distress may hinder the adoption of shorter immobilization times for nondisplaced waist fractures.

Is Deep Learning On Par with Human Observers for Detection of Radiographically Visible and Occult Fractures of the Scaphoid?

BACKGROUND: Preliminary experience suggests that deep learning algorithms are nearly as good as humans in detecting common, displaced, and relatively obvious fractures (such as, distal radius or hip fractures). However, it is not known whether this also is true for subtle or relatively nondisplaced fractures that are often difficult to see on radiographs, such as scaphoid fractures. QUESTIONS/PURPOSES: (1) What is the diagnostic accuracy, sensitivity, and specificity of a deep learning algorithm in detecting radiographically visible and occult scaphoid fractures using four radiographic imaging views? (2) Does adding patient demographic (age and sex) information improve the diagnostic performance of the deep learning algorithm? (3) Are orthopaedic surgeons better at diagnostic accuracy, sensitivity, and specificity compared with deep learning? (4) What is the interobserver reliability among five human observers and between human consensus and deep learning algorithm? METHODS: We retrospectively searched the picture archiving and communication system (PACS) to identify 300 patients with a radiographic scaphoid series, until we had 150 fractures (127 visible on radiographs and 23 only visible on MRI) and 150 non-fractures with a corresponding CT or MRI as the reference standard for fracture diagnosis. At our institution, MRIs are usually ordered for patients with scaphoid tenderness and normal radiographs, and a CT with radiographically visible scaphoid fracture. We used a deep learning algorithm (a convolutional neural network [CNN]) for automated fracture detection on radiographs. Deep learning, an advanced subset of artificial intelligence, combines artificial neuronal layers to resemble a neuron cell. CNNs-essentially deep learning algorithms resembling interconnected neurons in the human brain-are most commonly used for image analysis. Area under the receiver operating characteristic curve (AUC) was used to evaluate the algorithm's diagnostic performance. An AUC of 1.0 would indicate perfect prediction, whereas 0.5 would indicate that a prediction is no better than a flip of a coin. The probability of a scaphoid fracture generated by the CNN, sex, and age were included in a multivariable logistic regression to determine whether this would improve the algorithm's diagnostic performance. Diagnostic performance characteristics (accuracy, sensitivity, and specificity) and reliability (kappa statistic) were calculated for the CNN and for the five orthopaedic surgeon observers in our study. RESULTS: The algorithm had an AUC of 0.77 (95% CI 0.66 to 0.85), 72% accuracy (95% CI 60% to 84%), 84% sensitivity (95% CI 0.74 to 0.94), and 60% specificity (95% CI 0.46 to 0.74). Adding age and sex did not improve diagnostic performance (AUC 0.81 [95% CI 0.73 to 0.89]). Orthopaedic surgeons had better specificity (0.93 [95% CI 0.93 to 0.99]; p < 0.01), while accuracy (84% [95% CI 81% to 88%]) and sensitivity (0.76 [95% CI 0.70 to 0.82]; p = 0.29) did not differ between the algorithm and human observers. Although the CNN was less specific in diagnosing relatively obvious fractures, it detected five of six occult scaphoid fractures that were missed by all human observers. The interobserver reliability among the five surgeons was substantial (Fleiss' kappa = 0.74 [95% CI 0.66 to 0.83]), but the reliability between the algorithm and human observers was only fair (Cohen's kappa = 0.34 [95% CI 0.17 to 0.50]). CONCLUSIONS: Initial experience with our deep learning algorithm suggests that it has trouble identifying scaphoid fractures that are obvious to human observers. Thirteen false positive suggestions were made by the CNN, which were correctly detected by the five surgeons. Research with larger datasets-preferably also including information from physical examination-or further algorithm refinement is merited. LEVEL OF EVIDENCE: Level III, diagnostic study.

A Machine Learning Algorithm to Predict the Probability of (Occult) Posterior Malleolar Fractures Associated With Tibial Shaft Fractures to Guide "Malleolus First" Fixation.

OBJECTIVES: To develop an accurate machine learning (ML) predictive model incorporating patient, fracture, and trauma characteristics to identify individual patients at risk of an (occult) PMF. METHODS: Databases of 2 studies including patients with TSFs from 2 Level 1 trauma centers were combined for analysis. Using ten-fold cross-validation, 4 supervised ML algorithms were trained in recognizing patterns associated with PMFs: (1) Bayes point machine; (2) support vector machine; (3) neural network; and (4) boosted decision tree. Performance of each ML algorithm was evaluated and compared based on (1) C-statistic; (2) calibration slope and intercept; and (3) Brier score. The best-performing ML algorithm was incorporated into an online open-access prediction tool. RESULTS: Total data set included 263 patients, of which 28% had a PMF. Training of the Bayes point machine resulted in the best-performing prediction model reflected by good C-statistic, calibration slope, calibration intercept, and Brier score of 0.89, 1.02, -0.06, and 0.106, respectively. This prediction model was deployed as an open-access online prediction tool. CONCLUSION: A ML-based prediction model accurately predicted the probability of a (occult) PMF in patients with a TSF based on patient- and fracture-specific characteristics. This prediction model can guide surgeons in their diagnostic workup and preoperative planning. Further research is required to externally validate the model before implementation in clinical practice. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Surgical Excision with Adjuvant Irradiation for Treatment of Keloid Scars: A Systematic Review.

BACKGROUND: Excision followed by adjuvant irradiation is considered safe and most efficacious for treatment of keloid scars. Recently, different authors published successful treatment protocols and recommended the following: (1) the use of high-dose-rate brachytherapy instead of low-dose-rate brachytherapy or external radiation; (2) a short-time interval between operation and irradiation; (3) single fraction instead of multifraction irradiation; and (4) a minimum of 12- to 24-month follow-up post treatment. METHODS: This study evaluates the above recommendations with a systematic review of the English-language literature, based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement. Both PubMed and EMBASE were searched. Studies were graded according to the American Society of Plastic Surgeons Rating Levels of Evidence. RESULTS: Thirty-three studies were selected. Six studies were graded as level of evidence type II studies and 27 as type III. High-dose-rate brachytherapy showed lower recurrence rates compared with low-dose-rate brachytherapy and external radiation. A short-time (<7 hours) interval between scar excision and irradiation results in a lower recurrence rate compared with long-time intervals (>24 hours). Single-fraction irradiation showed promising results in terms of recurrence rate and patient convenience. Finally, scar recurrences were seen between 2 and 36 months, with a mean of 15 months. CONCLUSIONS: Based on this systematic review of the literature, the evidence confirms the recommendations stated by authors in the recent years. However, due to the lack of high-quality randomized studies, the quality of this evidence is limited. More randomized studies will generate stronger recommendations.

Intralesional Cryotherapy for the Treatment of Keloid Scars: Evaluating Effectiveness.

BACKGROUND: Intralesional (IL) cryotherapy is a novel treatment technique for keloid scars, in which the scar is frozen from inside. Over the past decade, several studies have been published with varying outcomes. A critical analysis of the current literature is, therefore, warranted to determine whether IL cryotherapy is an alternative to established keloid scar treatments. METHODS: A comprehensive review was performed, based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. PubMed and EMBASE were searched from inception. Studies and level of recommendation were graded according to the American Society of Plastic Surgeons criteria. RESULTS: Eight studies meeting the inclusion criteria were selected. The average scar volume decrease ranged from 51% to 63%, but no complete scar eradication was achieved on average. Scar recurrence ranged from 0% to 24%. Hypopigmentation posttreatment was seen mostly in Fitzpatrick 4-6 skin type patients. Finally, complaints of pain and pruritus decreased significantly in most studies. CONCLUSIONS: IL cryotherapy for the treatment of keloid scars shows favorable results in terms of volume reduction and alleviated complaints of pain and pruritus. However, no complete scar eradication is established, and recurrences are seen. Also, persistent hypopigmentation proved a problem in Fitzpatrick 4-6 skin type patients. Summarized, the evidence proved limited and inconsistent resulting in an American Society of Plastic Surgeons grade C recommendation for this type of treatment of keloid scars.

Comparison of two devices for the treatment of keloid scars with the use of intralesional cryotherapy: An experimental study.

BACKGROUND: Intralesional (IL) cryotherapy is a new technique for the treatment of keloid scars, in which the scar is frozen from inside. Two cryodevices are available, which were recently evaluated. Both devices showed promising results, but differed in clinical outcome. To explain these differences, more understanding of the working mechanism of both devices is required. OBJECTIVE: This experimental study was designed to investigate and compare the thermal behavior of an argon gas- and a liquid nitrogen-based device. Thermal behavior constitutes: (1) minimum tissue temperature (°C), (2) the freezing rate (°C/min). The thermal behavior was measured inside and on the outer surface of the scar. Both devices were tested ex vivo and in vivo. RESULTS: Ex vivo, when determining the maximum freezing capacity, the argon gas device showed a higher end temperature compared to the liquid nitrogen device (argon gas: -120°C, liquid nitrogen: -140°C) and a faster freezing rate (argon gas: -1300°C/min, liquid nitrogen: -145°C/min). In vivo, measured inside the keloid, the argon gas device showed a lower end temperature than the liquid nitrogen device (argon gas: -36.4°C, liquid nitrogen: -8.1°C) and a faster freezing rate (argon gas: -14.7°C/min, liquid nitrogen: -5°C/min). The outer surface of the scar reached temperatures below -20°C with both devices as measured with the thermal camera. CONCLUSION: In conclusion, the argon gas device displayed a lower end temperature and a faster freezing rate in vivo compared to the liquid nitrogen device. Although this resulted in lower recurrence rates for the argon gas device, more hypopigmentation was seen compared to the liquid nitrogen device following treatment. Finally, the low outer surface temperatures measured with both devices, suggest that some hypopigmentation following treatment is inevitable.

Intralesional cryotherapy for treatment of keloid scars: a prospective study.

BACKGROUND: Intralesional cryotherapy is a novel treatment for keloid scars in which the scar is frozen from inside. Published results are promising, but the treatment has only been tested in a Caucasian patient population. Therefore, the authors evaluated intralesional cryotherapy in a patient population including different Fitzpatrick skin types (I through VI). METHODS: This prospective multicenter study with a 1-year follow-up included 27 patients with 29 keloid scars. Intralesional cryotherapy was administered with a disposable liquid nitrogen-based device called CryoShape. Scar assessment was performed using the Patient and Observer Scar Assessment Scale and four objective devices to determine scar color, scar elasticity, scar volume, and patient skin type. RESULTS: Keloid scars showed an average volume decrease of 63 percent (range, 16 to 100 percent) after 12 months, compared with baseline (p < 0.01). Recurrence was seen in seven keloids (24 percent) and hypopigmentation recovered in 69 percent of all keloid scars within 12 months. Scar assessment with the Patient and Observer Scar Assessment Scale showed an overall improvement according to both doctors and patients. In addition, complaints of pain and itching were reduced. When analyzing the results per Fitzpatrick skin type, African American patients showed a higher incidence of persistent hypopigmentation (p = 0.02). CONCLUSIONS: Intralesional cryotherapy for the treatment of keloid scars shows favorable results in terms of reduction of volume and complaints of pain and pruritus. However, no complete eradication was obtained in some cases and recurring scars were seen. In addition, persistent hypopigmentation proved a problem in non-Caucasian patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

A new argon gas-based device for the treatment of keloid scars with the use of intralesional cryotherapy.

BACKGROUND: Intralesional (IL) cryotherapy is a new promising technique for the treatment of keloid scars, in which the scar is frozen from inside. Multiple devices are available, mostly based on a simple liquid nitrogen Dewar system, which have a limited freezing capacity. Argon gas-based systems ensure accurate and highly controlled freezing and have shown to be effective within the field of oncologic surgery. However, this technique has never been used for the treatment of keloid scars. OBJECTIVE: This prospective study evaluates an argon gas-based system for the treatment of keloids in a patient population including all Fitzpatrick skin types with a 1-year follow-up. METHODS: Twenty-five patients with 30 keloid scars were included and treated with a device called Seednet (Galil Medical, Yokneam, Israel). Scar quality and possible scar recurrence were assessed before treatment and post treatment (6 and 12 months) with objective devices determining scar color, scar elasticity, scar volume, and patient's skin type. In addition, scars were evaluated using the Patient and Observer Scar Assessment Scale. RESULTS: After 12 months, a significant volume reduction of 62% was obtained, p = 0.05. Moreover, complaints of pain and itching were alleviated and scar quality had improved according to the Patient and Observer Scar Assessment Scale. Scar pigmentation recovered in 62% of all keloid scars within 12 months. Five out of 30 (17%) scars recurred within 12 months, three of which had previously been treated with liquid nitrogen-based IL cryotherapy. Both recurrent and persistent hypopigmentation were mainly seen in Afro-American patients. CONCLUSIONS: IL cryotherapy with the use of an argon gas-based system proves to be effective in the treatment of keloid scars, yielding volume reduction and low recurrence rates. Although hypopigmentation recovered in most cases, it is strongly related to non-Caucasian patients. Finally, additional treatment of keloid scars previously unresponsive to IL cryotherapy is predisposed to a high recurrence rate. TRIAL NUMBER: NCT02063243.

High-dose-rate brachytherapy for the treatment of recalcitrant keloids: a unique, effective treatment protocol.

BACKGROUND: Keloids cause aesthetic disfigurement and physical complaints, mainly pain and pruritus. Treatment of these scars is difficult, with high recurrence rates forming the main issue. Surgical excision with adjuvant radiotherapy is considered the most efficacious treatment. At their institution, the authors have been treating keloids with a high-dose-rate brachytherapy procedure for over 10 years, using a protocol with the lowest total radiation dosage known in the literature. METHODS: This prospective study included 43 patients of all Fitzpatrick skin types, with 67 keloids in total. After extralesional excision, a radiation scheme of 2 × 6 Gy was administered in two fractions: the first within 4 hours after surgery and the second within 24 hours. Scars were measured and recurrence was judged. Scar appearance was evaluated using the Patient and Observer Scar Assessment Scale. RESULTS: The recurrence rate was 3.1 percent at a mean follow-up of 33.6 months. A significant average scar surface decrease of 56.7 percent was measured (p = 0.01). Complaints of pain and pruritus decreased by 82.9 and 87.2 percent, respectively. Patients were satisfied with the treatment in 88.6 percent of the cases and with the cosmetic result in 77.1 percent. Pigmentation problems were seen in 21.4 percent of the patients, mostly in Fitzpatrick type V and VI/African American individuals. CONCLUSIONS: The results of this prospective study show a good cosmetic outcome with a low recurrence rate. The unique radiation schedule proves the efficacy and safety of high-dose-rate brachytherapy and suggests the importance of immediate postoperative irradiation. In addition, only one outpatient treatment is required after surgery, enhancing patient convenience. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.