High Irritation and Removal Rates After Plate or Nail Fixation in Patients With Displaced Midshaft Clavicle Fractures.

BACKGROUND: Studies comparing plate with intramedullary nail fixation of displaced midshaft clavicle fractures show faster recovery in the plate group and implant-related complications in both groups after short-term followup (6 or 12 months). Knowledge of disability, complications, and removal rates beyond the first postoperative year will help surgeons in making a decision regarding optimal implant choice. However, comparative studies with followup beyond the first year or two are scarce. QUESTIONS/PURPOSES: We asked: (1) Does plate fixation or intramedullary nail fixation for displaced midshaft clavicle fractures result in less disability? (2) Which type of fixation, plate or intramedullary, is more frequently associated with implant-related irritation and implant removal? (3) Is plate or intramedullary fixation associated with postoperative complications beyond the first postoperative year? METHODS: Between January 2011 and August 2012, patients with displaced midshaft clavicle fractures were enrolled and randomized to plate or intramedullary nail fixation. A total of 58 patients with plate and 62 patients with intramedullary nails initially were enrolled. Minimum followup was 30 months (mean, 39 months; range, 30-51 months). Two patients (3%) with plate fixation and two patients (3%) with intramedullary nails were lost to followup. The QuickDASH was obtained at final followup and compared between patients who had plate fixation and those who had intramedullary nail fixation. Postoperative complications measured include infection, implant-related irritation, implant failure, nonunion, and refracture after implant removal. Indications for implant removal included implant-related irritation, implant failure, nonunion, patient's wish, or surgeon's preference. RESULTS: Between patients with plate versus intramedullary nail fixation, there were no differences in QuickDASH scores (plate, 1.8 ± 3.6; intramedullary nail, 1.8 ± 7.2; mean difference, -0.7; 95% CI, -2.2 to 2.04; p = 0.95). The proportion of patients having implant-related irritation was not different (39 of 56 [70%] versus 41 of 62 [66%]; relative risk, 1.05; 95% CI, 0.82-1.35; p = 0.683). Intramedullary fixation was associated with a higher likelihood of implant removal (51 of 62 [82%] versus 28 of 56 [50%]; relative risk, 1.65; 95% CI, 1.24-2.19; p < 0.001). Among the removed implants more plates than intramedullary nails were removed after the 1-year followup (12 of 28 [43%] versus six of 51 [12%]; p = 0.002). There were no infections, implant breakage, nonunions, or refractures between the 1-year and final followup in either group. CONCLUSIONS: After a mean followup of 39 months, disability scores were excellent. Major complications did not occur after the 1-year followup. A frequent and bothersome problem after both surgical treatments is implant-related irritation, resulting in high rates of implant removal, after 1 year. Future research could focus on analyzing risk factors for implant irritation or removal. LEVEL OF EVIDENCE: Level II, therapeutic study.

Isolated fat pad sign in acute elbow injury: is it clinically relevant?

An isolated fat pad sign (i.e. joint effusion without a visible fracture), commonly seen in acute elbow injury, is associated with occult fracture and treated as such. However, the clinical relevance of an isolated fat pad is unclear, thereby questioning the need for specialized follow-up. In this study, 111 patients (median age 15 years, interquartile range 9-27 years) with an isolated fat pad sign after acute elbow injury were included. The clinical relevance of an isolated fat pad sign was derived from descriptives on pain, elbow function, treatment change, number of revisits and recovery time after 1 week follow-up and long-term follow-up. Treatment alterations were rarely made and none of the patients needed an operative intervention; also, none of the patients had persistent symptoms. The median recovery time was 3 weeks (interquartile range 2-12 weeks). This study shows that, unless symptoms persist or worsen, regular follow-up at a specialized outpatient clinic is not needed.

Operative treatment of dislocated midshaft clavicular fractures: plate or intramedullary nail fixation? A randomized controlled trial.

BACKGROUND: Over the past decades, the operative treatment of displaced midshaft clavicular fractures has increased. The aim of this study was to compare short and midterm results of open reduction and plate fixation with those of intramedullary nailing for displaced midshaft clavicular fractures. METHODS: A multicenter, randomized controlled trial was performed in four different hospitals. The study included 120 patients, eighteen to sixty-five years of age, treated with either open reduction and plate fixation (n = 58) or intramedullary nailing (n = 62). Preoperative and postoperative shoulder function scores and complications were documented until one year postoperatively. Significance was set at p < 0.05. RESULTS: No significant differences in the Disabilities of the Arm, Shoulder and Hand (DASH) or Constant-Murley score (3.0 and 96.0 points for the plate group and 5.6 and 95.5 points for the nailing group) were noted between the two surgical interventions at six months postoperatively. Until six months after the surgery, the plate-fixation group experienced less disability than the nailing group as indicated by the area under the curve of the DASH scores for this time period (p = 0.02). The mean numbers of complications per patient, irrespective of their severity, were similar between the plate-fixation (0.67) and nailing (0.74) groups (p = 0.65). CONCLUSIONS: The patients in the plate-fixation group recovered faster than the patients in the intramedullary nailing group, but the groups had similar results at six months postoperatively and the time of final follow-up. The rate of complications requiring revision surgery was low. Implant-related complications occurred frequently and could often be treated by implant removal.

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.

Extension test and ossal point tenderness cannot accurately exclude significant injury in acute elbow trauma.

STUDY OBJECTIVE: Elbow injury is a common presentation at the emergency department (ED). There are no guidelines indicating which of these patients require radiography, whereas clinical decision rules for other limb injuries are widely accepted and resulted in less radiography and reduced waiting times. We aim to identify clinical signs that can be used to predict the need for radiography in elbow injury. METHODS: A prospective observational study at 2 ED locations in the Netherlands was performed. For every eligible patient with acute elbow injury, elbow extension and addition of point tenderness at the olecranon, epicondyles, and radial head were evaluated for predicting the need for radiography (primary endpoint). A subgroup of patients was assessed by a blinded second investigator to analyze interobserver variability (secondary endpoint). All patients received anterior-posterior and lateral elbow radiographs. Fractures were treated according to current guidelines and patients were followed at outpatient clinics. RESULTS: In total, 587 patients were included. Normal extension was observed in 174 patients (30%). Normal extension predicted absence of a fracture or isolated fat pad with 88% sensitivity and 55% specificity. Five patients with normal extension had a fracture that required surgery. Absence of point tenderness in patients with normal extension was observed in only 24 patients, of whom 3 showed a fracture and 1 required surgery. Addition of point tenderness to the extension test to predict absence of a fracture or isolated fat pad resulted in 98% sensitivity and 11% specificity. Interobserver analysis for extension and palpation of olecranon, epicondyles, and radial head resulted in κ values between 0.6 and 0.7. CONCLUSION: In contrast with previous studies, ours shows that in acute elbow injury, the extension test alone or in combination with point tenderness assessment does not safely rule out clinically significant injury. Interobserver variability was substantial. We would not recommend the use of the extension test (+/- point tenderness assessment) as a clinical decision rule to guide radiologic diagnostics in acute elbow trauma.

Guideline on anterior cruciate ligament injury.

The Dutch Orthopaedic Association has a long tradition of development of practical clinical guidelines. Here we present the recommendations from the multidisciplinary clinical guideline working group for anterior cruciate ligament injury. The following 8 clinical questions were formulated by a steering group of the Dutch Orthopaedic Association. What is the role of physical examination and additional diagnostic tools? Which patient-related outcome measures should be used? What are the relevant parameters that influence the indication for an ACL reconstruction? Which findings or complaints are predictive of a bad result of an ACL injury treatment? What is the optimal timing for surgery for an ACL injury? What is the outcome of different conservative treatment modalities? Which kind of graft gives the best result in an ACL reconstruction? What is the optimal postoperative treatment concerning rehabilitation, resumption of sports, and physiotherapy? These 8 questions were answered and recommendations were made, using the "Appraisal of Guidelines for Research and Evaluation" instrument. This instrument seeks to improve the quality and effectiveness of clinical practical guidelines by establishing a shared framework to develop, report, and assess. The steering group has also developed 7 internal indicators to aid in measuring and enhancing the quality of the treatment of patients with an ACL injury, for use in a hospital or practice.

Treatment of torus fractures in the forearm in children using bandage therapy.

BACKGROUND: In a torus fracture, there is an intact cortex at the side of the fracture which gives more intrinsic stability than in greenstick fractures, where one side of the cortex is disrupted. Two previously done studies compared soft bandage therapy (BT) with cast therapy in the treatment of torus forearm fractures in children and showed this is safe and does not cause any complications. The aim of our study was to validate these studies by treating all patients presenting to emergency department with a torus fracture with BT and investigate whether any complications occur. METHODS: At a single-center from January 2009 to June 2009, all patients with an impacted greenstick fracture of the distal radius and/or ulna without exception were treated using BT. Primary endpoint was secondary angulation; secondary endpoint was pain on Visual Analog Score. RESULTS: Seven patients were misdiagnosed as torus fractures but were actually greenstick fractures and had to be excluded. A total of 49 patients with a torus fracture were included in statistical analysis. No fracture displacement was seen. Four patients needed an additional nonsteroidal antiinflammatory drug or an antalgic plaster cast. The overall Visual Analog Score of the patients was lower than in previous studies. CONCLUSIONS: Soft BT is safe in all children without risk of further angulation and with a pain score equal to cast therapy. Important is that misdiagnosis of the torus fracture at initial presentation should be minimized.

The proximal femur nail antirotation: an identifiable improvement in the treatment of unstable pertrochanteric fractures?

BACKGROUND: The optimal surgical treatment of patients with an unstable extracapsular proximal femoral fracture is yet to be found. From the biomechanical point of view, the use of an intramedullary device in combination with a dynamic femoral head/neck stabilization implant seems an optimal technique. One of these intramedullary devices, the Proximal Femoral Nail (PFN), has several drawbacks in practice. The Proximal Femur Nail Antirotation (PFNA) has been designed to address these. We hypothesized that the placement of one femoral head/neck fixation device in the PFNA would improve positioning of the implant in the femoral head compared with the PFN and reduce the number of reoperations in both short and long term. METHODS: We followed 157 consecutive patients with unstable trochanteric fractures (Arbeitsgemeinschaft für Osteosynthesefragen classification 31.A.2 and A.3) treated with a PFN or a PFNA for 1 year. The radiologic position of the implant was evaluated, and the postoperative local and systemic complications were registered. RESULTS: The position of the femoral head/neck stabilization implant was "good" in 39 (44.8%) patients in the PFN group and 23 (32.9%) patients in the PFNA group; the position was "acceptable" in 30 (34.5%) versus 33 (47.1%) patients, and in 18 (20.7%) versus 14 (20%) patients, the position was "poor" (p = 0.277). Because of implant-related complications, three patients in the PFN group and four patients in the PFNA group needed an early reoperation (p = 0.136). A late reoperation because of implant-related complications was performed in 13 patients in the PFN group and in three in the PFNA group (p = 0.016). CONCLUSIONS: This study shows that osteosynthesis with the PFNA does not improve the position of the implant in the femoral head compared with the PFN. However, the risk of a secondary complication and the necessity of a late reoperation are significantly higher in patients treated with a PFN compared with patients treated with a PFNA.

Treatment of impacted greenstick forearm fractures in children using bandage or cast therapy: a prospective randomized trial.

BACKGROUND: To evaluate the relative risks and advantages of using soft bandage therapy (BT) for impacted greenstick fractures of the distal forearm compared with cast therapy (CT). METHODS: At a single center from September 2005 to October 2006 all patients with an impacted greenstick fracture were randomized to BT or CT. RESULTS: A total of 92 patients were randomized and assigned. No fracture displacement was seen. Three patients from the BT group were converted to standard treatment. A significant difference in pain was seen between both groups after 1 week in favor of the CT group. Discomfort was significantly less in the BT group compared with the CT group. After 4 weeks, the wrist function was significantly better in the BT group. After 6 weeks, the wrist functions of both the groups were comparable. CONCLUSIONS: BT for impacted greenstick fractures of the distal forearm is a safe technique, patients treated with bandage suffer greater pain at the start of the treatment, are able to return to normal activities sooner, and have less discomfort when compared with the standard CT.

Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients.

BACKGROUND: The treatment of open fractures of the tibial shaft is often complicated by delayed union and nonunion. The objective of this study was to evaluate the safety and efficacy of the use of recombinant human bone morphogenetic protein-2 (rhBMP-2; dibotermin alfa) to accelerate healing of open tibial shaft fractures and to reduce the need for secondary intervention. METHODS: In a prospective, randomized, controlled, single-blind study, 450 patients with an open tibial fracture were randomized to receive either the standard of care (intramedullary nail fixation and routine soft-tissue management [the control group]), the standard of care and an implant containing 0.75 mg/mL of rhBMP-2 (total dose of 6 mg), or the standard of care and an implant containing 1.50 mg/mL of rhBMP-2 (total dose of 12 mg). The rhBMP-2 implant (rhBMP-2 applied to an absorbable collagen sponge) was placed over the fracture at the time of definitive wound closure. Randomization was stratified by the severity of the open wound. The primary outcome measure was the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months postoperatively. RESULTS: Four hundred and twenty-one (94%) of the patients were available for the twelve-month follow-up. The 1.50-mg/mL rhBMP-2 group had a 44% reduction in the risk of failure (i.e., secondary intervention because of delayed union; relative risk = 0.56; 95% confidence interval = 0.40 to 0.78; pairwise p = 0.0005), significantly fewer invasive interventions (e.g., bone-grafting and nail exchange; p = 0.0264), and significantly faster fracture-healing (p = 0.0022) than did the control patients. Significantly more patients treated with 1.50 mg/mL of rhBMP-2 had healing of the fracture at the postoperative visits from ten weeks through twelve months (p = 0.0008). Compared with the control patients, those treated with 1.50 mg/mL of rhBMP-2 also had significantly fewer hardware failures (p = 0.0174), fewer infections (in association with Gustilo-Anderson type-III injuries; p = 0.0219), and faster wound-healing (83% compared with 65% had wound-healing at six weeks; p =0.0010). CONCLUSIONS: The rhBMP-2 implant was safe and, when 1.50 mg/mL was used, significantly superior to the standard of care in reducing the frequency of secondary interventions and the overall invasiveness of the procedures, accelerating fracture and wound-healing, and reducing the infection rate in patients with an open fracture of the tibia.