The DASH and Constant-Murley are valid instruments for evaluating outcome in patients with a humeral shaft fracture. Reliability was only shown for the DASH, making this the preferred instrument. The observed MIC and SDC values provide a basis for sample size calculations for future research.
Between 1990 and 2001, 292 patients with acute Achilles tendon rupture were admitted to our institution. Depending on the day of admission patients were allocated either to the Department of Trauma Surgery or to the Department of Orthopaedics. Two hundred and twelve patients (mean age 37±9.4 years) were treated with surgical suture followed by plaster for 6 weeks. Eighty patients were treated non-surgically with splinting for 12 weeks. For both groups mean follow-up was 6±3 years. There were 14 re-ruptures, ten after surgical repair and four after non-surgical treatment. In the surgical group there were seven major wound problems, 11 minor wound complications and six patients with complaints from the sural nerve. In the non-surgical group one patient suffered a pulmonary embolism after a re-rupture, 3 months after the initial rupture. There was no difference in mean ankle score and patient-satisfaction score between groups. Only 52% regained their original sports activity level, slightly better in the surgically treated group. With a nonsignificant difference in re-rupture rate but relatively more complications after surgical repair, non-surgical treatment is preferred. With a slightly better recovery of sports activity after surgical repair, this might be used as an argument for surgical treatment in young athletes.Résumé Entre 1990 et 2001, 292 malades avec une rupture du tendon d'Achille ont été admis dans notre institution. Selon le jour de l'admission les malades ont été alloués au Département de Traumatologie ou au Départe-ment d'Orthopédie. 212 malades (âge moyen 37±9,4 ans) ont été traité par suture chirurgicale suivie d'un plâtre pour 6 semaines et 80 malades ont été traités conservativement avec attelle pour 12 semaines. Pour les deux groupes la moyenne de suivi était de 6±3 années. Il y avait 14 ruptures itératives, 10 après réparation chirurgicale et quatre après traitement non chirurgical. Dans le groupe chirurgical il y avait sept problèmes majeurs de paroi, 11 complications mineures de paroi et six malades avec souffrance du nerf sural. Dans le groupe non chirurgical un malade a eu une embolie pulmonaire après une rupture itérative, trois mois après la rupture initiale. Il n'y avait aucune différence dans le score moyen de la cheville et le score de satisfaction des malades entre les deux groupes. Seulement 52% ont regagné leur niveau d'activité sportive original, légèrement mieux dans le groupe traité chirurgicalement. Avec une différence non significative dans le taux des ruptures itératives mais relativement plus de complications après réparation chirurgicale, le traitement non -chirurgical est préféré. La récupération sportive légèrement meilleure après réparation chirurgicale est un élément de discussion pour le traitement chirurgical chez les jeunes athlètes.
BackgroundFractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery.Methods/designThe design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective.DiscussionSuccessful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture.Trial registrationThe trial is registered at the Netherlands Trial Register (NTR3617).
BackgroundElbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are treated with open reduction and internal fixation (ORIF), or arthroplasty in case of a non-reconstructable radial head fracture. If the elbow joint remains unstable after fracture fixation, a hinged elbow fixator can be applied. The fixator provides stability to the elbow joint, and allows for early mobilization. The latter may be important for preventing stiffness of the joint. The aim of this study is to determine the effect of early mobilization with a hinged external elbow fixator on clinical outcome in patients with complex elbow dislocations with residual instability following fracture fixation.Methods/DesignThe design of the study will be a multicenter prospective cohort study of 30 patients who have sustained a complex elbow dislocation and are treated with a hinged elbow fixator following fracture fixation because of residual instability. Early active motion exercises within the limits of pain will be started immediately after surgery under supervision of a physical therapist. Outcome will be evaluated at regular intervals over the subsequent 12 months. The primary outcome is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford Elbow Score, pain level at both sides, range of motion of the elbow joint at both sides, radiographic healing of the fractures and formation of periarticular ossifications, rate of secondary interventions and complications, and health-related quality of life (Short-Form 36).DiscussionThe outcome of this study will yield quantitative data on the functional outcome in patients with a complex elbow dislocation and who are treated with ORIF and additional stabilization with a hinged elbow fixator.Trial RegistrationThe trial is registered at the Netherlands Trial Register (NTR1996).
Purpose The best treatment of humeral shaft fractures in adults is still under debate. This study aimed to compare functional and clinical outcome of operative versus nonoperative treatment in adult patients with a humeral shaft fracture. We hypothesized that operative treatment would result in earlier functional recovery. Methods From October 23, 2012 to October 03, 2018, adults with a humeral shaft fracture AO type 12A or 12B were enrolled in a prospective cohort study in 29 hospitals. Patients were treated operatively or nonoperatively. Outcome measures were the Disabilities of the Arm, Shoulder, and Hand score (DASH; primary outcome), Constant–Murley score, pain (Visual Analog Score, VAS), health-related quality of life (Short Form-36 (SF-36) and EuroQoL-5D-3L (EQ-5D)), activity resumption (Numeric Rating Scale, NRS), range of motion (ROM) of the shoulder and elbow joint, radiologic healing, and complications. Patients were followed for one year. Repeated measure analysis was done with correction for age, gender, and fracture type. Results Of the 390 included patients, 245 underwent osteosynthesis and 145 were primarily treated nonoperatively. Patients in the operative group were younger (median 53 versus 62 years; p < 0.001) and less frequently female (54.3% versus 64.8%; p = 0.044). Superior results in favor of the operative group were noted until six months follow-up for the DASH, Constant–Murley, abduction, anteflexion, and external rotation of the shoulder, and flexion and extension of the elbow. The EQ-US, and pronation and supination showed superior results for the operative group until six weeks follow-up. Malalignment occurred only in the nonoperative group (N = 14; 9.7%). In 19 patients with implant-related complications (N = 26; 10.6%) the implant was exchanged or removed. Nonunion occurred more often in the nonoperative group (26.3% versus 10.10% in the operative group; p < 0.001). Conclusion Primary osteosynthesis of a humeral shaft fracture (AO type 12A and 12B) in adults is safe and superior to nonoperative treatment, and should therefore be the treatment of choice. It is associated with a more than twofold reduced risk of nonunion, earlier functional recovery and a better range of motion of the shoulder and elbow joint than nonoperative treatment. Even after including the implant-related complications, the overall rate of complications as well as secondary surgical interventions was highest in the nonoperative group. Trial registration NTR3617 (registration date 18-SEP-2012).
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