The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective.

BACKGROUND: Questions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0. METHODS: A total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid exposure were randomized to the TIF group or PPI group. Following the 6-month evaluation, all patients in the PPI group elected for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation and atypical symptoms at the 5-year follow-up. Secondary outcomes were improvement in symptom scores, PPI use, reoperations, and patient health satisfaction. The cost-effectiveness of TIF 2.0 was also estimated. RESULTS: Of 63 patients, 60 were available at 1 year, 52 at 3 years, and 44 at 5 years for evaluation. Troublesome regurgitation was eliminated in 88% of patients at 1 year, 90% at 3 years, and 86% at 5 years. Resolution of troublesome atypical symptoms was achieved in 82% of patients at 1 year, 88% at 3 years, and 80% at 5 years. No serious adverse events occurred. There were 3 reoperations by the end of the 5-year follow-up. At the 5-year follow-up, 34% of patients were on daily PPI therapy as compared with 100% of patients at screening. The total GERD Health-related quality-of-life score improved by decreasing from 22.2 to 6.8 at 5 years ( P < .001). CONCLUSION: In this patient population, the TIF 2.0 procedure provided safe and sustained long-term elimination of troublesome GERD symptoms.

The Prevalence of Congenital Hand and Upper Extremity Anomalies Based Upon the New York Congenital Malformations Registry.

BACKGROUND: There have been few publications regarding the prevalence of congenital upper extremity anomalies and no recent reports from the United States. The purpose of this investigation was to examine the prevalence of congenital upper extremity anomalies in the total birth population of New York State over a 19-year period utilizing the New York Congenital Malformations Registry (NYCMR) database. METHODS: The NYCMR includes children with at least 1 birth anomaly diagnosed by 2 years of age and listed by diagnosis code. We scrutinized these codes for specific upper extremity anomalies, including polydactyly, syndactyly, reduction defects, clubhand malformations, and syndromes with upper limb anomalies. We included children born between 1992 and 2010. RESULTS: There were a total of 4,883,072 live births in New York State during the study period. The overall prevalence of congenital upper extremity anomalies was 27.2 cases per 10,000 live births. Polydactyly was most common with 12,418 cases and a prevalence rate of 23.4 per 10,000 live births. The next most common anomalies included syndactyly with 627 cases affecting the hands (1498 total) and reduction defects (1111 cases). Specific syndromes were quite rare and were noted in a total of 215 live births. The prevalence of anomalies was higher in New York City compared with New York State populations at 33.0 and 21.9 per 10,000 live births, respectively. CONCLUSIONS: The NYCMR data demonstrate that congenital upper extremity anomalies are more common than previously reported. This is in large part due to the high prevalence of polydactyly. Although registries are imperfect, such data are helpful in monitoring prevalence rates over time, identifying potential causes or associations, and guiding health care planning and future research. LEVEL OF EVIDENCE: Level I-diagnostic.

The effect of soft tissue distraction on deformity recurrence after centralization for radial longitudinal deficiency.

PURPOSE: To assess recurrence and complications in children with radial longitudinal deficiency treated with or without external fixator soft tissue distraction prior to centralization. METHODS: Thirteen upper extremities treated with centralization alone were compared with 13 treated with ring fixator distraction followed by centralization. Resting wrist position between the 2 groups was compared before surgery, approximately 2 years after surgery (midterm), and at final follow-up, which was at a mean of 10 years for the centralization-alone group and 6 years for the distraction group. Radiographs were reviewed for hand-forearm angle, hand-forearm position, volar carpal subluxation, ulnar length, and physeal integrity. RESULTS: The clinical resting wrist position was improved significantly after surgery and at final follow-up in both groups, but recurrence was worse at final follow-up in the distraction group patients. Radiographically, in the centralization alone group, the hand-forearm angle improved from 53° before surgery to 13° at midterm but worsened to 27° at final follow-up. In the distraction group, the hand-forearm angle improved from 53° before surgery to 21° at midterm but worsened to 36° at final follow-up. The hand-forearm position improved between preoperative and final assessment in both groups, but at final follow-up, the centralization-alone group had a significantly better position. Volar subluxation was 4 mm improved in the centralization alone group and 2 mm worse in the distraction group at final follow-up. CONCLUSIONS: Centralization, with or without distraction with an external fixator, resulted in improved alignment of the wrist. Distraction facilitated centralization, but it did not prevent deformity recurrence and was associated with a worse final radial deviation and volar subluxation position compared with wrists treated with centralization alone. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic III.

Intermediate-term to long-term outcome of surgically and nonsurgically treated congenital, isolated radial head dislocation.

PURPOSE: Adolescent patients with congenital radial head dislocation presenting with pain and limitation in motion might benefit from radial head excision. We report objective and patient-rated data for patients treated with radial head excision and those followed nonsurgically. We hypothesized that surgery would improve pain and motion and that outcomes and the need for additional surgery would be similar between the 2 groups. METHODS: We reviewed our surgical logs and identified 16 patients (10 treated surgically and 6 treated nonsurgically) for participation. At a mean of 10 years for the surgical group and 16 years after initial office visit for the nonsurgical group, we collected patient-rated and objective data, including range of motion, strength, and pain at the wrist or elbow. RESULTS: Eight of 16 patients had bilateral dislocations. Preoperative and postoperative elbow flexion (137° versus 135°) and extension (27° versus 23°) were unchanged in surgically treated patients. Forearm rotation was improved after surgery (100° versus 119°). Carrying angle was similar between surgical (17°) and nonsurgical (13°) elbows, but surgically treated elbows had significantly different ulnar variance at +4.9 mm compared to -0.4 mm for the nonsurgically treated patients. Surgically treated patients had significant improvement in elbow pain following radial head excision. Final Quick Disabilities of the Arm, Shoulder, and Hand scores were similar between groups, although there were lower mean scores among nonsurgically treated patients. CONCLUSIONS: Radial head excision in patients with symptomatic, isolated, congenital radial head dislocations resulted in substantial pain relief and patient satisfaction but modest improvement in forearm rotation and no improvement in elbow flexion-extension. Furthermore, more than 25% of the surgically treated limbs developed wrist pain and needed additional surgery. The nonsurgical group did not lose motion, develop pain, or need surgery. This information might help make the decision whether to excise the radial head in patients with symptomatic, congenital radial head dislocation.

Complex syndactyly: aesthetic and objective outcomes.

PURPOSE: Outcome data after the treatment of complex syndactyly are lacking. The purpose of this investigation was to critically analyze and report our results after surgical reconstruction of complex syndactyly. METHODS: We included 13 patients and 21 hands (25 webspaces) in this retrospective call-back investigation. There were 17 middle/ring finger and 8 ring/little finger complex syndactylies, each with a defined, isolated osseous bridge between the distal phalanges. We excluded complicated and syndrome-associated syndactylies. Patients returned for clinical examination and subjective assessment at an average of 9 years (range, 2-27 y) after the most recent surgery. Of 21 hands, 6 had undergone a revision surgery. RESULTS: The Vancouver Scar Scale scores averaged 3 (range, 0-6), web creep averaged 1.5 (range, 0-3), and total active motion averaged 148° for the affected fingers. In the middle/ring finger syndactylies, the middle finger was most commonly supinated (average, 13°) and ulnarly deviated (average, 9°), and the ring finger was either supinated or pronated and radially deviated (average, 13°). In the ring/little finger syndactylies, the ring finger was most commonly supinated (average, 8°) without deviation, and the little finger was most commonly pronated (average, 8°) and radially deviated (average, 24°). There was a notable nail wall deformity in most fingers. Surgeon visual analog scale scores (range, 0-10, where lower scores are better) averaged 2.8 (range, 0.8-5.0). Patient visual analog scale scores were 0.4 (range, 0-3) for pain, 1.9 (range, 0-10) for appearance, and 1.1 (range, 0-3) for function. CONCLUSIONS: Complex syndactyly reconstruction is challenging, and common postsurgical findings include rotational and angular deformity and nail deformity. When deformity was present, the fingers typically rotated away from and deviated toward the site of the previous complex syndactyly. We describe how we have altered our approach based on these findings. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Idiopathic multicentric osteolysis: upper extremity manifestations and surgical considerations during childhood.

PURPOSE: Idiopathic multicentric osteolysis (IMO) is an uncommon disease presenting during childhood with resorption of the carpus and tarsus with nephropathy. The few case reports and literature reviews do not focus on the upper extremity disease manifestations or surgical treatment options. We review our experience with the upper extremity in IMO. METHODS: We evaluated 8 affected children, specifically assessing early disease manifestations, misdiagnoses, radiographic progression, and surgical treatments rendered. RESULTS: Wrist pain and swelling are typically the first manifestations of IMO. Characteristic upper extremity findings, once the disease has progressed, include metacarpophalangeal joint hyperextension, wrist ulnar deviation and flexion, and loss of elbow extension. Radiographically, there is osteolysis of the carpus and proximal metacarpals with resorption of the elbow joint in some patients. Surgical treatments, including soft tissue release with pinning or joint arthrodesis, may offer pain relief and improve alignment, but outcomes are inconsistent. CONCLUSIONS: Children with IMO are almost always misdiagnosed initially, and the correct diagnosis may be delayed by years. The hand surgeon is ideally suited to provide an accurate diagnosis of IMO, because wrist pain and swelling and thumb interphalangeal joint contracture are common early manifestations. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic IV.

Surgical and nonsurgical treatment of cubital tunnel syndrome in pediatric and adolescent patients.

PURPOSE: Few studies have investigated the presence or treatment of cubital tunnel syndrome in pediatric or adolescent patients. We conducted this retrospective investigation to quantify success rates of nonsurgical care and to assess patient outcomes after surgical intervention. METHODS: We identified 39 extremities treated for cubital tunnel syndrome between 2000 and 2009 at one institution. We documented patient demographic data, precipitating events, symptomatology, physical examination findings, and treatment for all patients. We assessed patient-rated outcomes with validated measures including the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and the visual analog scale (VAS). RESULTS: Subjective complaints at the time of presentation included 16 extremities with ulnar nerve instability at the elbow, 21 extremities with pain at the elbow, and 15 extremities with numbness and tingling in the ring and small fingers. Physical examination revealed 33 extremities with a positive Tinel sign and 20 extremities with a positive elbow flexion-compression test. In the nonsurgical group (9), pretreatment DASH scores averaged 32 and posttreatment DASH scores averaged 11. Pretreatment recall VAS pain scores had a median of 7, and were similar to posttreatment scores, which had a median of 3. In the surgical group (30), DASH scores averaged 46 before surgery and improved to 7 at final follow-up. The VAS pain scores improved from a median of 8 before surgery to 2 after surgery. A total of 30 patients (from both groups) were treated with a trial of nonsurgical care without symptom resolution. CONCLUSIONS: Cubital tunnel syndrome in pediatric or adolescent patients is rare. It can be treated successfully with surgical intervention. Although nonsurgical treatment is unlikely to relieve symptoms in this patient population, a trial of nighttime splinting, activity modification, and anti-inflammatory medications remains appropriate for most patients. Surgical intervention is effective for symptom relief if nonsurgical care fails. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic III.

Elbow radiographic anatomy: measurement techniques and normative data.

BACKGROUND: An increase in elbow pathology in adolescents has paralleled an increase in sports participation. Evaluation and classification of these injuries is challenging because of limited information regarding normal anatomy. The purpose of this study was to evaluate normal radiographic anatomy in adolescents to establish parameters for diagnosing abnormal development. Established and new measurements were evaluated for reliability and variance based on age and sex. METHODS: Three orthopaedic surgeons independently, and in a standardized fashion, evaluated the normal anteroposterior and lateral elbow radiographs of 178 adolescent and young adult subjects. Fourteen measurements were performed including radial neck-shaft angle, articular surface angle, articular surface morphologic assessment (subjective and objective evaluation of the patterns of ridges and sulci), among others. We performed a statistical analysis by age and sex for each measure and assessed for inter- and intraobserver reliability. RESULTS: The distal humerus articular surface was relatively flat in adolescence and became more contoured with age, as objectively demonstrated by increasing depth of the trochlear and trochleocapitellar sulci, and decreasing trochlear notch angle. Overall measurements were similar between males and females, with an increased carrying angle in females. There were several statistically significant differences based on age and sex; but these were small and unlikely to be clinically significant. Inter and intraobserver reliability were variable; some commonly utilized tools had poor reliability. CONCLUSION: Most commonly utilized radiographic measures were consistent between sexes, across the adolescent age group, and between adolescents and young adults. Several commonly used assessment tools show poor reliability.

Ulnocarpal epiphyseal arthrodesis for recurrent deformity after centralization for radial longitudinal deficiency.

PURPOSE: To report our results for ulnocarpal epiphyseal arthrodesis for recurrent or late-presenting wrist deformity in patients with radial longitudinal deficiency, using both objective data and long-term subjective follow-up evaluation. METHODS: A retrospective review of our surgical logs between 1970 and 2007 identified 12 postcentralization patients treated with ulnocarpal epiphyseal arthrodesis, and 1 patient (who had reached skeletal maturity) treated with traditional ulnocarpal arthrodesis. Indications for the arthrodesis included postcentralization recurrence of radial angulation to greater than 45°, an inability to actively extend the wrist to within 25° of neutral (ie, 25° of flexion), or both. We collected objective and radiographic data on all 12 patients by chart review at a mean of 89 months (range, 2-472 mo) after arthrodesis. We collected subjective data from 9 patients at a mean of 160 months (range, 14-602 mo) after arthrodesis. RESULTS: Ulnocarpal union was obtained in 11 wrists at an average of 4 months (range, 2-6 mo); the 1 case of nonunion was treated successfully with revision arthrodesis. The mean radial angulation position was 20° after arthrodesis (range, 0° to 35°), an average improvement of 42°. The mean position of wrist fusion was 11° of flexion (range, 0° to 35° of flexion), an average improvement of 7°. The mean postoperative Disabilities of the Arm, Shoulder, and Hand score was 24.5 (SD, 12.3; range, 6.8-36.4). Final postoperative Visual Analog Score rating for function averaged 8 (range, 4-10); for appearance, it averaged 7 (range, 5-10), and for pain, it averaged 1 (range, 0-5). CONCLUSIONS: Ulnocarpal and epiphyseal arthrodesis are appropriate surgical procedures to stabilize the carpus in postcentralization patients with recurrent or late-presenting wrist deformity. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Skeletal and chronological ages in American adolescents: current findings in skeletal maturation.

PURPOSE: This study was designed to assess the relationship between skeletal and chronological ages among current American adolescents using the Greulich and Pyle atlas for skeletal age determination. MATERIALS AND METHODS: We used the Greulich and Pyle atlas to prospectively determine skeletal age in a group of 138 otherwise healthy American adolescents from 12 to 18 years of age. 62 males and 76 females were enrolled in this cohort. Paired Student t-tests were used to statistically compare the skeletal and chronological ages in this population. Subgroup analysis examined the effect of gender on differences between chronologic age and skeletal age. RESULTS: For the entire cohort, mean skeletal age was significantly greater than chronological age (mean 0.80 years, P < 0.01). In 29 cases (21%) the skeletal age was at least 2 years greater than the chronologic age. Among females, such cases with marked discrepancy occurred exclusively in those chronologically between 12 and 15 years of age (P < 0.01). Males demonstrated a 2-year or greater discrepancy more commonly than females (26 vs. 17%). In males, 2-year discrepancies were equally likely across chronologic ages (P = 0.82). CONCLUSIONS: Current American adolescents are significantly more mature by skeletal age, as determined by the Greulich and Pyle method, than their chronological age would suggest. The skeletal ages of females are most likely to markedly exceed chronologic age between the ages of 12-15 years.

Thumb in the plane of the hand: characterization and results of surgical treatment.

PURPOSE: The purpose of this retrospective investigation is to characterize a congenital deformity, the thumb in the plane of the hand (TPH), and to evaluate the results of abduction-rotation osteotomy of the thumb metacarpal with thumb web space deepening (WSD). METHODS: We performed a comprehensive analysis of the medical records, hand therapy notes, and radiographs to evaluate clinical features of the TPH deformity. We evaluated clinical and radiographic outcomes and incidence of deformity recurrence after abduction-rotation osteotomy and thumb WSD. RESULTS: Thirteen patients (7 girls and 6 boys) with 14 affected hands treated with an abduction-rotation osteotomy of the thumb metacarpal and formation of a deepened thumb-index web space met inclusion criteria. All TPH deformities were associated with other congenital conditions, including symbrachydactyly, syndactyly, central deficiency, and ulnar deficiency. During the course of treatment, patients had a mean of 4 surgeries per hand; 3 hands required osteotomy revision with or without revision WSD, and 6 additional hands required revision of thumb WSD alone. None of the affected hands were capable of thumb opposition to any finger before surgery, whereas after surgery, all 14 hands could actively perform key pinch, and 9 of the 14 hands could actively oppose the thumb to at least 1 finger. CONCLUSIONS: The TPH deformity occurs in association with other congenital abnormalities of the hand. An abduction-rotation osteotomy of the thumb metacarpal with thumb WSD can restore thumb opposition and improve function; nonetheless, multiple surgical procedures are often required, and thumb function may remain limited. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Arthroscopic assessment of intra-articular distal radius fractures after open reduction and internal fixation from a volar approach.

PURPOSE: The volar approach with locked plating is a common treatment for intra-articular distal radius fractures. The purpose of this study was to arthroscopically assess the articular surface after internal fixation through the volar approach as a means to evaluate the ability of an extra-articular reduction to anatomically restore the joint surface. METHODS: Sixteen patients with intra-articular distal radius fractures were prospectively enrolled. A volar approach and internal fixation using a locked volar plate was performed. Using a visual analog scale (VAS), the fracture reduction was clinically graded on the quality of reduction of the visible metaphyseal fracture lines, fluoroscopically graded, and arthroscopic graded. Maximum step and gap deformity were recorded from arthroscopy and plain radiograph. RESULTS: The mean VAS score for the fracture reduction based on extra-articular fracture lines was 7.4. The mean VAS score for the fluoroscopic reduction was 8.2. The mean VAS score for the arthroscopic reduction was 6.4. The arthroscopic VAS score was significantly lower than the VAS score for fluoroscopy but was not significantly different than the VAS score for metaphyseal reduction. Mean arthroscopic measurement of maximum step and gap deformity were 1 mm and 2 mm, respectively. Mean postoperative radiographic maximum step and gap deformity were both less than 1 mm. The arthroscopic step and gap deformities were significantly greater than the radiographic deformities. CONCLUSIONS: A volar approach, indirect reduction, and locked plate fixation is a useful technique in restoring articular congruity after distal radius fracture. The number of fracture lines and presence of step and gap deformity can be adequately assessed using clinical and fluoroscopic assessment. However, the magnitude of step and gap deformity may be underestimated.