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).

Preliminary results of cannulated screw fixation for isolated pubic ramus fractures.

Isolated pubic ramus fractures are common fractures in the elderly, and treatment is typically non-operative. Up to 35 % of patients have a prolonged hospital stay due to pain. A small number of these patients do not respond to standard (non-operative) treatment. We retrospectively reviewed six patients with isolated pubic ramus fractures and persistent pain who were treated with percutaneous retrograde pubic ramus screw fixation. The study group consisted of six women with an average age of 81 years (72-86 years). Patients with symptomatic posterior pelvic ring injuries were excluded. All patients showed improvement after surgery, with three patients pain free and three patients with reduced pain. The mean time spent in the hospital was 9 days (range 3-18 days). There were complications post-operatively: two patients had pneumonia, two with confusional states, and one patient had a urinary tract infection. Despite these events, which are associated with surgery in patients with comorbidites from advanced age, retrograde pubic ramus screw fixation is an effective treatment option for patients with persistent pain from isolated pubic fractures.

Operative aspects of the syndesmotic screw: review of current concepts.

The distal tibiofibular syndesmosis is important for stability of the ankle mortise and thus for weight transmission and walking. Syndesmotic injuries are most commonly associated with fibular fractures, but they can also occur in isolation or with damage to the lateral ankle ligament after traumatic supination. The need for trans-syndesmotic fixation of the distal tibiofibular joint has been controversial. The goal of this review was to collect evidence on the technical aspects of performing an osteosynthesis using a syndesmotic screw and to formulate some recommendations for clinical practice.

Which ankle fractures require syndesmotic stabilization?

Syndesmotic ruptures associated with ankle fractures are most commonly caused by external rotation of the foot, eversion of the talus within the ankle mortise, and excessive dorsiflexion. The distal tibiofibular syndesmosis consists of the anterior inferior tibiofibular ligament, posterior inferior tibiofibular ligament, and interosseous ligament, and it is essential for stability of the ankle mortise. Despite the numerous biomechanical and clinical studies pertaining to ankle fractures, there are no uniform recommendations regarding the use of the syndesmotic screw for specific injury patterns and fracture types. The objective of this review was to formulate recommendations for clinical practice related to the use of syndesmotic screw placement.

Advanced trauma life support study: quality of diagnostic and therapeutic procedures.

BACKGROUND: The introduction of the ATLS course in The Netherlands in 1995 provided for an opportunity to compare data of trauma patients between a pre-ATLS and a post-ATLS period. MATERIALS AND METHODS: Over a 3-year period (May 1996 - September 1997 pre ATLS; December 1997-April 1999 post ATLS) 63 trauma patients with an AIS-ISS > or = 16 (n = 31, pre-ATLS and n = 32, post-ATLS) were prospectively studied in two community residency training (ACS Level III) hospitals. All diagnostic and therapeutic procedures were recorded by a video-camera and evaluated by a neutral faculty of six experienced ATLS trained specialists. RESULTS: Ten out of 14 interventions were performed qualitatively better in the post-ATLS group, while also the overall score was highly significantly better (4.2 pre-ATLS and 5.8 post-ATLS, p < 0.0001). CONCLUSION: Using the opinion of an expert team, this study identified a significantly lower number of patients with inadequate management.

Clinical impact of advanced trauma life support.

The Advanced Trauma Life Support (ATLS) course sponsored by the American College of Surgeons Committee On Trauma (ACSCOT) presents a standardized method of initial trauma care. This study attempted to measure any changes in morbidity and mortality in trauma patients after the introduction of ATLS training. Over a 3-year period (May 1996 to September 1997-pre-ATLS period; December 1997 to April 1999-post-ATLS period), 63 trauma patients with an Injury Severity Scale (ISS) > or =16 (n = 31, pre-ATLS and n = 32, post-ATLS) were prospectively studied in two community teaching hospitals. There was no significant difference in mortality rate between groups (48% [15 of 31] pre-ATLS vs. 30% [10 of 32] post-ATLS; P = .203, Fisher exact test). Mortality rates within the ISS range of 16 to 25 were 64% (nine of 14 pre-ATLS) versus 29% (five of 17 post-ATLS), and for the ISS 26 to 35 subgroup, 40% (four of 10 pre-ATLS) versus 25% (two of eight post-ATLS), and within the ISS 36 to 75 subgroup, 29% (two of seven pre-ATLS) versus 43% (three of seven post-ATLS). There was a significant difference in mortality during the first 60 minutes after admission: 0.0% post-ATLS versus 24.2% pre-ATLS (P = .002, Fisher exact test (95% confidence interval ranged from 12-45% in the pre-ATLS group and 0-11% in the post-ATLS group). According to the TRISS methodology (a worldwide-accepted mathematical method to calculate chances of survival through logistical regression),ATLS improved outcome from sub-"Major Trauma Outcome Study" (MTOS) standard results (z = -2.9 to a MTOS standard result z = -0.49). Our data demonstrate that introduction of the ATLS program significantly improved trauma patient outcome in the first hour after admission, as well as improvement from sub-MTOS standard to MTOS standard levels.

Overgrowth and correction of rotational deformity in 12 femoral shaft fractures in 3-6-year-old children treated with an external fixator.

We treated 11 young children (3-6 years old) who had uncomplicated femoral shaft fractures primarily with an external fixator. 9 children were available for follow-up and were evaluated for the amount of overgrowth and rotational deformity. All underwent a clinical examination and an MRI after mean 21 (13-25) months. The mean overgrowth was 0.4 (-0.3-1.1) cm and the anteversion angle showed a mean increase of 12 degrees, as compared to the contralateral femur. In 5 children with an anteversion angle difference of 10 degrees or more, a second MRI was done 4 years after the trauma. The mean anteversion angle difference of the femora in these 5 children had diminished from 15 degrees on the first MRI to 7.4 degrees on the second. 3 of the 5 children had a full correction of their rotational deformity. Growth did not correct the rotational deformity in the oldest child in this group.