Functional recovery after treatment of extra-articular distal radius fractures in the elderly using the IlluminOss® System (IO-Wrist); a multicenter prospective observational study.

BACKGROUND: Approximately 17 % of all fractures involve the distal radius. Two-thirds require reduction due to displacement. High redislocation rates and functional disability remain a significant problem after non-operative treatment, with up to 30 % of patients suffering long-term functional restrictions. Whether operative correction is superior to non-operative treatment with respect to functional outcome has not unequivocally been confirmed. The IlluminOss® System was introduced in 2009 as a novel, patient-specific, and minimally invasive intramedullary fracture fixation. This minimally invasive technique has a much lower risk of iatrogenic soft tissue complications. Because IlluminOss® allows for early mobilization, it may theoretically lead to earlier functional recovery and ADL independence than non-operative immobilization. The main aim of this study is to examine outcome in elderly patients who sustained a unilateral, displaced, extra-articular distal radius fracture that was treated with IlluminOss®. METHODS/DESIGN: The design of the study will be a multicenter, prospective, observational study (case series). The study population comprises elderly (60 years or older; independent in activities of daily living) with a unilateral, displaced, extra-articular distal radius fracture (AO/OTA type 23-A2 and A3) that after successful closed reduction was fixed within 2 weeks after the injury with IlluminOss®. Critical elements of treatment will be registered, and outcome will be monitored until 1 year after surgery. The Disabilities of the Arm, Shoulder, and Hand score will serve as primary outcome measure. The Patient-Rated Wrist Evaluation score, level of pain, health-related quality of life (Short Form-36 and EuroQoL-5D), time to ADL independence, time to activities/work resumption, range of motion of the wrist, radiological outcome, and complications are secondary outcome measures. Health care consumption and lost productivity will be used for a cost analysis. The cost analysis will be performed from a societal perspective. Descriptive data will be reported. DISCUSSION: The results of this study will provide evidence on the effectiveness of operative treatment of patients who sustained an extra-articular distal radius fracture with the IlluminOss® System, using clinical, patient-reported, and societal outcomes. TRIAL REGISTRATION: The study is registered at the Netherlands Trial Register ( NTR5457 ; 29-sep-2015).

A randomized controlled trial of nonoperative treatment versus open reduction and internal fixation for stable, displaced, partial articular fractures of the radial head: the RAMBO trial.

BACKGROUND: The choice between operative or nonoperative treatment is questioned for partial articular fractures of the radial head that have at least 2 millimeters of articular step-off on at least one radiograph (defined as displaced), but less than 2 millimeter of gap between the fragments (defined as stable) and that are not associated with an elbow dislocation, interosseous ligament injury, or other fractures. These kinds of fractures are often classified as Mason type-2 fractures. Retrospective comparative studies suggest that operative treatment might be better than nonoperative treatment, but the long-term results of nonoperative treatment are very good. Most experts agree that problems like reduced range of motion, painful crepitation, nonunion or bony ankylosis are infrequent with both nonoperative and operative treatment of an isolated displaced partial articular fracture of the radial head, but determining which patients will have problems is difficult. A prospective, randomized comparison would help minimize bias and determine the balance between operative and nonoperative risks and benefits. METHODS/DESIGN: The RAMBO trial (Radial Head - Amsterdam - Amphia - Boston - Others) is an international prospective, randomized, multicenter trial. The primary objective of this study is to compare patient related outcome defined by the 'Disabilities of Arm, Shoulder and Hand (DASH) score' twelve months after injury between operative and nonoperative treated patients. Adult patients with partial articular fractures of the radial head that comprise at least 1/3rd of the articular surface, have ≥ 2 millimeters of articular step-off but less than 2 millimeter of gap between the fragments will be enrolled. Secondary outcome measures will be the Mayo Elbow Performance Index (MEPI), the Oxford Elbow Score (OES), pain intensity through the 'Numeric Rating Scale', range of motion (flexion arc and rotational arc), radiographic appearance of the fracture (heterotopic ossification, radiocapitellar and ulnohumeral arthrosis, fracture healing, and signs of implant loosening or breakage) and adverse events (infection, nerve injury, secondary interventions) after one year. DISCUSSION: The successful completion of this trial will provide evidence on the best treatment for stable, displaced, partial articular fractures of the radial head. TRIAL REGISTRATION: The trial is registered at the Dutch Trial Register: NTR3413.

HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER): a multicenter comparative observational study.

BACKGROUND: Fractures 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/DESIGN: The 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. DISCUSSION: Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR3617).

Outcome after osteosynthesis of hip fractures in nonagenarians.

BACKGROUND: Hip fractures in the elderly population are associated with high morbidity and mortality. However, there is still a lack of information on mortality and loss of independence in extremely elderly people with a hip fracture. OBJECTIVE: To study functional outcomes and mortality after osteosynthesis of hip fractures in very old patients in our clinic. PATIENTS AND METHODS: Hospital charts of all patients over 90 years old who were operated for a hip fracture between January 2007 and December 2011 were reviewed. Outcome measures were mortality, preoperative and postoperative mobility, and loss of independence. RESULTS: A total of 149 patients were included; 132 (89%) women, median age 93.5±2.45 years. Thirty-six (24%) patients were classified as American Society of Anesthesiologists (ASA) grade 2, 104 (70%) as ASA grade 3, and nine (6%) as ASA grade 4. The Charlson comorbidity index (CCI) score was 2 or less in 115 (77%) patients and 34 (23%) patients scored 3 or more points. Short-term survival was 91% and 77% at 30 days and 3 months, respectively. Long-term survival was 64%, 42%, and 18% at 1, 3, and 5 years after surgery, respectively. Survival was significantly better in patients with lower ASA scores (P=0.005). No significant difference in survival was measured between patients according to CCI score (P=0.13). Fifty-one percent of patients had to be accommodated in an institution with more care following treatment, and 57% were less mobile after osteosynthesis of a hip fracture. CONCLUSION: Our study shows that short-term mortality rates in very elderly patients with a hip fracture are high and there is no clear predictive value for mortality. ASA classification is the best predictive value for overall mortality. A large proportion of these patients lost their independence after osteosynthesis of a hip fracture.

Osteoporosis and radial head fractures in female patients: a case-control study.

BACKGROUND: Identifying radial head fractures as fragility fractures may improve case-findings for osteoporosis and thus be an indicator other fragility fractures. MATERIALS AND METHODS: Thirty-five women aged ≥ 50 years with a radial head fracture and 57 controls were retrospectively selected and matched for age in strata of 5 years. Peripheral bone mineral density (BMD) measurement was performed at the calcaneus. A T score of less than -2.7 was considered osteoporosis. If the T value was between -1.4 and -2.7, an additional dual energy X-ray (DXA) scan was performed. RESULTS: The patients were a median age of 60 years compared with 58 years for the control patients (P = .33). The mean T score of the patients was -1.8 (standard deviation [SD], 1.0; range, -2.2 to -0.3) compared with -1.2 (SD, 1.2; range, -4.0 to 1.3) for the control patients (P = .04). Osteoporosis was diagnosed in 11 patients and in 5 control patients. The patients had an increased risk of osteoporosis compared with the control patients (odds ratio, 3.4; P = .027). CONCLUSIONS: This study confirms that radial head fractures in women aged ≥ 50 years are potentially osteoporotic fractures. Offering these patients a BMD measurement may prevent future osteoporotic fractures, such as hip and spine fractures.

Magnetic resonance imaging in radial head fractures: most associated injuries are not clinically relevant.

BACKGROUND: Recent studies report that magnetic resonance imaging (MRI) shows a high incidence of associated injuries in patients with a radial head fracture. This retrospective study describes the clinical relevance of these injuries. MATERIALS AND METHODS: Forty patients with 42 radial head fractures underwent a MRI scan after a mean of 7.0 days after trauma and were reviewed after a mean of 13.3 months. RESULTS: MRI showed 24 of 42 elbows had a lateral collateral ligament (LCL) lesion, 1 had a medial collateral ligament (MCL) and LCL lesion, 16 had an injury of the capitellum, 1 had a coronoid fracture, and 2 had loose osteochondral fragments. Clinical evaluation after a mean of 13.3 months showed that 3 elbows had clinical MCL or LCL laxity, of which 2 elbows had no ligamentous injuries diagnosed with MRI. One elbow with a loose osteochondral fragment showed infrequent elbow locking. The mean Mayo Elbow Performance Scale was 97.5 (range, 80-100) after a mean of 13.3 months after trauma, with no significant difference between patients with and without associated injuries (P = .8). CONCLUSION: Most injuries found with MRI in patients with radial head fractures are not symptomatic or of clinical importance in short-term follow-up.

Delayed primary closure of the septic open abdomen with a dynamic closure system.

BACKGROUND: The major challenge in the management of patients with an infected open abdomen (OA) is to control septic peritonitis and intra-abdominal fluid secretion, and to facilitate repeated abdominal exploration, while preserving the fascia for delayed primary closure. We here present a novel method for closure of the infected OA, based on continuous dynamic tension, in order to achieve re-approximation of the fascial edges of the abdominal wall. METHODS: Eighteen cases with severe peritonitis of various origin (e.g., gastrointestinal perforations, anastomotic leakage) were primarily stabilized by laparostomy, sealed with either the vacuum-assisted closure abdominal dressing or the Bogotá bag. After hemodynamic stabilization and control of the sepsis, the Abdominal Re-approximation Anchor System (ABRA; Canica Design, Almonte, Ontario, Canada) was applied. This system approximates the wound margins through dynamic traction exerted by transfascial elastomers. Before ABRA application, 5/18 patients had a grade 2B, 2/18 a grade 3, and 11/18 a grade or 4 status according to the open abdomen classification of Björck. RESULTS: In this severely ill population the mean time before ABRA system application was 12 days (range: 2-39 days). Two of 18 patients died of non-ABRA-related causes within three weeks. In 14 of the remaining 16 patients (88%) primary abdominal closure of the midline was accomplished in 15 days (range: 7-30 days). The other two patients needed a component separation technique according to Ramirez to reach closure. However, secondary wound dehiscence occurred in both these patients. Two thirds of patients (12/18) developed pressure sores to the skin and/or dermis, but all healed without further complications. During outpatient clinic follow-up, 4/14 successfully closed patients still developed a midline hernia. CONCLUSIONS: Delayed primary closure of OA in septic patients could be achieved in 88% with this new approximation system. However, the risk of hernia development remained. We consider this system a useful tool in the treatment of septic patients with an open abdomen.

A hinged external fixator for complex elbow dislocations: a multicenter prospective cohort study.

BACKGROUND: Elbow 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/DESIGN: The 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). DISCUSSION: The 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 REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR1996).

Functional treatment versus plaster for simple elbow dislocations (FuncSiE): a randomized trial.

BACKGROUND: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. METHODS/DESIGN: The design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for pro-supination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure 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, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation), health-related quality of life (Short-Form 36 and EuroQol-5D), radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications), costs, and cost-effectiveness. DISCUSSION: The successful completion of this trial will provide evidence on the effectiveness of a functional treatment for the management of simple elbow dislocations. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR2025).

Magnetic resonance imaging findings in 46 elbows with a radial head fracture.

BACKGROUND AND PURPOSE: Radial head fractures are common, and may be associated with other injuries of clinical importance. We present the results of a standard additional MRI scan for patients with a radial head fracture. PATIENTS AND METHODS: 44 patients (mean age 47 years) with 46 radial head fractures underwent MRI. 17 elbows had a Mason type-I fracture, 23 a Mason type-II fracture, and 6 elbows had a Mason type-III fracture. RESULTS: Associated injuries were found in 35 elbows: 28 elbows had a lateral collateral ligament lesion, 18 had capitellar injury, 1 had a coronoid fracture, and 1 elbow had medial collateral ligament injury. INTERPRETATION: The incidence of associated injuries with radial head fractures found with MRI was high. The clinical relevance should be investigated.

The epidemiology of radial head fractures.

INTRODUCTION: Recent literature shows an increased mean age of female patients with radial head fractures compared with male patients with radial head fractures. However, data on epidemiology of radial head fractures and specifically in relation to age distribution and male-female ratios of radial head fracture are scarce. MATERIALS AND METHODS: A retrospective database search was performed to identify all patients with a radial head fracture over a 3-year period. RESULTS: A total of 328 radial head fractures were diagnosed in 322 patients. The incidence was 2.8 per 10,000 inhabitants per year. The male-female ratio was 2:3. The mean age was 48.0 years (range, 14-88 years; SD, 14.8). The mean age of female patients (52.8 years) was significantly higher than that of male patients (40.5 years) (P = .001). As the age increases above 50 years, the number of female patients becomes significantly higher than the number of male patients (P = .001). An associated osseous injury was present in 40 patients (12.4%). CONCLUSIONS: Radial head fractures are common, and associated injuries are frequent.

Reconstruction of isolated scaphoid dislocation with carpal dissociation, associated with a carpal anomaly.

A case is presented of isolated scaphoid dislocation with carpal dissociation in the presence of a lunato-triquetral coalition. We present the treatment and follow-up of this case. In addition, the literature on scaphoid dislocation and its treatment is reviewed. We emphasize the need to reconstruct the carpal alignment and scapho-lunate linkage.

The incidence of associated fractures of the upper limb in fractures of the radial head.

Radial head fractures are common injuries. In American publications, one-third of the patients with these fractures have been shown to have associated injuries. The aim of this retrospective study is to describe the epidemiology of radial head fractures and associated fractures of the ipsilateral upper extremity in a European population. This study describes the epidemiology of radial head and associated fractures of the upper extremity in a Dutch population by a retrospective radiographic review of all patients with a radial head fracture between 1 January 2006 and 1 July 2007. A total of 147 radial head fractures were diagnosed in 145 patients. The incidence in the general population was 2.5 per 10.000 per year. The average age was 45.9 (SD 17.3) years and male-female ratio was 2:3. The mean age of males was significantly lower (37.1, SD 14.2 years) than of women (53.9, SD 16.4 years). Associated fracture of the upper extremity was found in 10.2%. Coronoid fractures were most common (4.1%). Associated upper limb fractures in patients with a radial head fracture are common in the European population. It is of clinical importance to suspect associated lesions and to perform a thorough physical examination and additional radiological examination on demand.