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 \u27Disabilities of Arm, Shoulder and Hand (DASH) score\u27 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 \u27Numeric Rating Scale\u27, 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. © 2014Bruinsma et al.; licensee BioMed Central Ltd

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

Management of the failed radial head arthroplasty

Primary radial head arthroplasty (RHA) produces good or excellent results in approximately 85% of patients. However, complications are not uncommon and have been described in up to 23% of cases. The number of RHA is increasing, and consequently the absolute number of complications is expected to rise as well. The decision on whether to revise or remove the prosthesis seems more likely to depend on the preference of the surgeon or the hospital, rather than on objectifying problems with the prosthesis. The current article presents an algorithm for the work-up and treatment of most complications that can occur following RHA. Five subgroups of problems were identified: osteoarthritis, stiffness, instability, infection and implant-related issues. In short, the preferred treatment depends mainly on the chondral condition and stability of the elbow joint

Outcomes after revision total elbow arthroplasty: a systematic review

Background: Although revision arthroplasty surgery is a frequently used treatment for failed total elbow arthroplasty (TEA), published results are conflicting. The aim of this systematic review was to provide an overview of the outcomes of revision TEA surgery. Methods: A systematic literature search was performed in major databases to find articles relating to outcomes after revision of TEA. Two reviewers independently screened the articles for inclusion, and a third reviewer screened them before final inclusion. Results: Twenty-one articles containing 532 cases were included. The mean age at revision was 61 years. The mean interval between primary and revision arthroplasty was 77 months, and the average follow-up period was 65 months. Different types of prostheses were included, with 69% of the revision prostheses having linked designs and 31% having unlinked designs. The visual analog scale score, Mayo Elbow Performance Score, Oxford Elbow Score, and range of motion improved significantly after revision surgery. Complications were reported in 232 of 532 cases (44%), leading to reoperations in 22%. After revision with linked prostheses, the Mayo Elbow Performance Score, range of flexion-extension, and pronation improved significantly more than with unlinked designs. Conclusion: Improved functional outcomes can be expected after revision TEA, but the complication rate remains high. Revision TEA should still be considered a salvage procedure for failed TEA. Linked designs for revision TEA result in better outcomes than unlinked designs in the midterm follow-up

Clinical and radiographic outcome of revision surgery of radial head prostheses: midterm results in 16 patients

Little is known about revision surgery of radial head arthroplasty. The aim of this study was to report on the clinical and radiographic outcome of revision arthroplasty of the elbow with a bipolar metallic radial head prosthesis. Between 2006 and 2013, we used either a press-fit or cemented RHS bipolar radial head prosthesis for revision surgery of radial head arthroplasty in 16 patients. Patients were prospectively enrolled in the study. Differences in outcome parameters before and after revision surgery were compared. At a mean follow-up of 75 months (range, 36-116 months), none of the revised radial head prostheses needed a second revision. None of the stems showed radiographic signs of loosening. In 1 patient the head was dissociated from the prosthesis. The average flexion-extension arc was 127° (range, 105°-140°), and the average pronation-supination arc was 138° (range, 90°-160°). Stability scores improved after revision surgery, resulting in 13 stable elbows (P = .01). In 8 patients the Oxford Elbow Score was between 37 and 48 points. The percentage of patients with either good or excellent results according to the Mayo Elbow Performance Score was 63%. The mean score on the EQ-5D (EuroQol Five Dimensions) was 80 (range, 63-100), and the visual analog scale scores both for pain at rest and for pain with activity improved to 3 (range, 0-9) and 4 (range, 0-9), respectively (P  < .001). All but 1 patient was satisfied with the results of the revision procedure. The clinical and radiographic outcomes of revision surgery of a radial head prostheses are favorabl

Cemented bipolar radial head arthroplasty: midterm follow-up results

Theoretical advantages of bipolar over monopolar radial head arthroplasty include better accommodation of radiocapitellar malalignment, reduction of capitellar abrasion, and reduction of stress at the bone-to-cement and cement-to-implant interfaces. Our purpose was to report the midterm results of cemented bipolar radial head arthroplasty. Twenty-five patients were treated by cemented bipolar radial head arthroplasty for acute fracture of the radial head, earlier treatment that had failed, or posttraumatic sequelae. One patient refused follow-up after surgery. Results are presented for the remaining 24 patients. At a mean follow-up of 50 months (range, 24-72 months), 1 prosthesis (4%) had been removed 2 years after implantation for dissociation of the prosthesis due to failure of the snap-on mechanism. There were 2 (8%) additional radiologic failures in the subluxated position: 1 prosthesis due to malalignment of the radius onto the capitellum and another due to ulnohumeral erosion. The average flexion-extension arc was 129° (range, 80°-140°), and the average pronation-supination arc was 131° (range, 40°-180°). According to the Mayo Elbow Performance Score, the combined excellent and good results accounted for 83%. In 8 patients, the bipolar design compensated for radiocapitellar malalignment. The overall midterm outcome of this series of 25 cemented bipolar radial head arthroplasties can be considered favorable. There was 1 (4%) revision and 2 (8%) additional radiologic failures. The bipolar design was able to compensate for radiocapitellar malalignment. We suggest considering a cemented bipolar radial head prosthesis in case of concerns about radiocapitellar alignmen

Clinical and radiographic outcome of revision surgery of total elbow prosthesis: midterm results in 19 cases

The aim of this study is to report on the midterm outcomes and complications of revision surgery of total elbow arthroplasty. All patients who had undergone total elbow arthroplasty revision surgery between 2009 and 2014 with semiconstrained total elbow prostheses were prospectively enrolled in the study. Records were reviewed for demographic data; baseline measurements; and several follow-up assessments including the Mayo Elbow Performance Score (MEPS), visual analog scale (VAS) score for pain, Oxford Elbow Score, range of motion, satisfaction, and radiographs. A total of 19 revision arthroplasties were included. At a mean follow-up of 57 months, there had been 1 rerevision and 2 removals. One patient was excluded from follow-up because of confounding comorbidity. At last follow-up, MEPS values and VAS pain scores both improved (P  < .01). The rate of combined good and excellent results on the MEPS was 53%. The mean VAS scores for pain at rest and with activity were 2 and 4, respectively. Fair results for the Oxford Elbow Score were reported, with a mean score of 28 points. Range of motion improved to an average flexion-extension arc of 108° (P  < .01), and the pronation-supination arc improved to an average of 123° (P  < .01). All elbows were stable at last follow-up (P  < .01). Radiographs showed nonprogressive osteolysis around the prosthesis in 3 cases (19%) and suspicion of loosening in 1 (6%). In 11 patients postoperative complications occurred. Of 15 patients, 13 (87%) were satisfied with the result of the revision procedure. Revision of total elbow prostheses leads to satisfactory results, less pain, and better elbow function. This procedure is related to a relatively high complication rat

Global trends in indications for total elbow arthroplasty: A systematic review of national registries

National registries provide useful information in understanding outcomes of surgeries that have late sequelae, especially for rare operations such as total elbow arthroplasty (TEA). A systematic search was performed and data were compiled from the registries to compare total elbow arthroplasty outcomes and evaluate trends. We included six registries from Australia, the Netherlands, New Zealand, Norway, the United Kingdom and Sweden. Inflammatory arthritis was the most common indication for total elbow arthroplasty, followed by acute fracture and osteoarthritis. When comparing 2000-2009 to 2010-2017 data, total elbow arthroplasty for inflammatory arthritis decreased and total elbow arthroplasty for fracture and osteoarthritis increased. There was an increase in the number of revision TEAs over this time period. The range of indications for total elbow arthroplasty is broadening; total elbow arthroplasty for acute trauma and osteoarthritis is becoming increasingly more common. However, inflammatory arthritis remains the most common indication in recent years. This change is accompanied by an increase in the incidence of revision surgery

The effect of trauma and patient related factors on radial head fractures and associated injuries in 440 patients

Radial head fractures are commonly interpreted as isolated injuries, and it is assumed that the energy transferred during trauma has its influence on the risk on associated ipsilateral upper limb injuries. However, relationships between Mason classification, mechanism of injury, and associated injuries have been reported only once before in a relatively small population. The purpose of this study was to define whether trauma mechanism and patient related factors are of influence on the type of radial head fracture and associated injuries to the ipsilateral upper limb in 440 patients. The radiographs and medical records of 440 patients that presented with a fracture of the radial head were retrospectively analyzed. The medical records of all patients were searched for (1) the trauma mechanism and (2) associated injuries of the ipsilateral upper limb. The mechanism of injury was classified as being low-energy trauma (LET) or high-energy trauma (HET). Associated injuries to the ipsilateral upper limb were present in 46 patients (11%). The mean age of patients with associated injuries (52 years) was significantly higher compared to patients without associated injuries (47 years) (P = 0.038), and female patients with a radial head fracture were older than males. Injury patterns were classified as LET in 266 patients (60%) and as HET in 174 patients. HETs were significantly more common in young men. Associated injuries were not significantly different distributed between HET versus LET (P = 0.82). Injuries concomitant to radial head fractures were present in 11% of patients and the risk for these associated injuries increases with age. Trauma mechanism did not have a significant influence on the risk of associated injuries. Complex elbow trauma in patients with a radial head fracture seems therefore to be suspected based on patient characteristics, rather than mechanism of injur

Press-fit bipolar radial head arthroplasty, midterm results

Theoretical advantages of bipolar compared with monopolar radial head arthroplasty include better accommodation of radiocapitellar malalignment, reduction of capitellar abrasion, and reduction of stress at the bone-implant interfaces. Our purpose was to report the midterm results of press-fit bipolar radial head arthroplasty. Thirty patients were treated by press-fit bipolar radial head arthroplasty for acute fracture of the radial head, failed earlier treatment, or post-traumatic sequelae. Three patients were lost to follow-up. Results are presented for the remaining 27 patients. At mean follow-up of 48 months (range, 28-73), there had been 3 (11%) revisions. Two involved conversion to prosthetic radiocapitellar hemiarthroplasty for symptomatic capitellar abrasion; a third involved exchange of the articular component (ie, head) for instability. In all, the stems appeared well fixed. A prosthesis in a subluxed position accounted for the 1 (4%) additional radiologic failure. The average flexion-extension arc was 136° (range, 120°-145°), and the average pronation-supination arc was 138° (range, 70°-180°). According to the Mayo Elbow Performance Score, the combined excellent and good results accounted for 70%. The overall midterm outcome of this series of 30 press-fit bipolar radial head arthroplasties can be considered favorable. Although the revision rate was 11%, the stems were well fixed in all. There was 1 (4%) additional radiologic failure. We suggest considering a press-fit bipolar radial head prosthesis for acute comminuted radial head fractures with limited bone loss of the proximal radiu