The goal of this trial was to determine whether coronal plane angulation affects functional and clinical outcomes after the fixation of distal femur fractures.
Multicenter, randomized controlled ...trial
20 academic trauma centers
156 patients with distal femur fractures were enrolled. 123 patients were followed 12 months. There was clinical outcome data available for 105 patients at 3 months, 95 patients at 6 months and 81 patients at one year.
Lateral locked plating or retrograde intramedullary nailing
Radiographic alignment, functional scoring including SMFA, Bother Index, and EQ-5D. Clinical scoring of walking ability, need for ambulatory support and ability to manage stairs.
At 3 months, there was no difference between groups (varus, neutral or valgus) with respect to any of the clinical functional outcome scores measured. At 6 months, compared to those with neutral alignment, patients with varus angulation had a worse Stair Climbing score (4.33 vs. 2.91, p = 0.05). At 12 months, the average patient with neutral or valgus alignment needed less ambulatory support than the average patient in varus. Walking distance ability was no different between the groups at any time point.
With respect to the validated patient-based outcome scores, we found no statistical difference in in the SMFA, Bother, or EQ-5D between patients with valgus or varus mal-alignment and those with neutral alignment at any time point (p > 0.05). Regardless of coronal angulation, the SMFA trended towards lower (improved) scores over time, while EQ-5D scores for patients with varus angulation did not improve over time.
Valgus angulation and neutral angulation may be better tolerated in terms of clinical outcomes like stair climbing and need for ambulatory support than varus angulation, though patient reported outcome measures like the SMFA, Bother Index and EQ-5D show no statistical significance. Most patients with distal femur fractures tend to improve during the first year after injury but many remain significantly affected at 12 months post injury.
Abstract Introduction The majority of periprosthetic fractures around the knee occur at the supracondylar region of the distal femur. Fixation of distal femoral fractures in osteoporotic bone with ...short segment remains a challenge, especially after total knee arthroplasty (TKA). Internal fixation of these fractures using locking plates has become popular. The purpose of this study was to evaluate a consecutive series of periprosthetic supracondylar femoral fractures treated with locked periarticular plate fixation with regard to surgical procedure, complications and clinical outcome. Materials and methods From two academic trauma centres, 55 consecutive periprosthetic distal femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association, AO/OTA 33) were retrospectively identified as having been treated with locked plate fixation. Of these, 36 fractures in 35 patients (86.1% female) met the inclusion criteria. Patients had an average age of 73.2 years (range 54–95 years). Fixation constructs for plate length and working length were delineated. Nonunion, infection and implant failure were used as complication variables. Demographics were assessed. Outcome was addressed radiographically and clinically according to Kristensen et al. by range of motion and pain. Results Twenty-five of 36 fractures (69.4%) healed after the index procedure. Eight of 36 fractures (22.2%) developed a nonunion with three fractures (8.3%) leading to hardware failure. Nine of the 36 patients (25%) were radiographically diagnosed with notching of the anterior femoral cortex. Regarding technical aspects, distance from the anterior flange of the femoral component to fracture was significantly shorter in patients with compared to without anterior notching ( t = 3.68, p = 0.02). Patients who underwent submuscular plate insertion compared to an extensive lateral approach had a reduced nonunion risk ( χ2 = 0.05). No difference in infection rate was found for submuscular procedures compared with open procedures ( χ2 = 0.85). Range of motion was reduced in most of the patients and 13.5% had a persistent loss of extension of 5°. More than 77% of the patients reported no or only mild pain during the last office visit. Range of motion loss did not influence pain. Successful treatment according to Cain et al. was achieved in 83%. Using Kristensen's criteria, 56% of the knees had acceptable flexion. Conclusion Operative fixation of periprosthetic distal femoral fractures after TKA continues to be challenging. Notching of the anterior femoral cortex should be avoided. Loss of reduction and high failure rates still occur with locked plating and may be related to underlying factors. Indirect reduction and submuscular plate insertion technique reduce nonunion risk.
BackgroundThe optimal choice for the stabilization of displaced femoral neck fractures remains controversial, with alternatives including arthroplasty and internal fixation. Our objective was to ...determine the effect of arthroplasty (hemiarthroplasty, bipolar arthroplasty, and total hip arthroplasty), compared with that of internal fixation, on rates of mortality, revision, pain, function, operating time, and wound infection in patients with a displaced femoral neck fracture.MethodsWe searched computerized databases for randomized clinical trials published between 1969 and 2002, and we identified additional studies through hand searches of major orthopaedic journals, bibliographies of major orthopaedic textbooks, and personal files. Of 140 citations initially identified, fourteen met all eligibility criteria. Three investigators independently graded study quality and abstracted relevant data, including information on revision and mortality rates.ResultsNine trials, which included a total of 1162 patients, provided detailed information on mortality rates over the first four postoperative months, which ranged from 0% to 20%. We found a trend toward an increase in the relative risk of death in the first four months after arthroplasty compared with the risk in the first four months after internal fixation (relative risk, 1.27). At one year, the relative risk of death was 1.04. The risk of death after arthroplasty appeared to be higher than that after fixation with a compression screw and side-plate but not higher than that after internal fixation with use of screws only (relative risk = 1.75 and 0.86, respectively; p < 0.05). Fourteen trials that included a total of 1901 patients provided data on revision surgery. The relative risk of revision surgery after arthroplasty compared with the risk after internal fixation was 0.23 (p = 0.0003). Pain relief and the attainment of overall good function were similar in patients treated with arthroplasty and those treated with internal fixation (relative risk, 1.12 for pain relief and 0.99 for function). Infection rates ranged from 0% to 18%, and arthroplasty significantly increased the risk of infection (relative risk, 1.81; p = 0.009). In addition, patients who underwent arthroplasty had greater blood loss and longer operative times than those who were treated with internal fixation.ConclusionsIn comparison with internal fixation, arthroplasty for the treatment of a displaced femoral neck fracture significantly reduces the risk of revision surgery, at the cost of greater infection rates, blood loss, and operative time and possibly an increase in early mortality rates. Only larger trials will resolve the critical question of the impact on early mortality.Level of EvidenceTherapeutic study, Level I-2 (systematic review of Level-I randomized controlled trials studies were homogeneous). See Instructions to Authors for a complete description of levels of evidence.
OBJECTIVE:Does immediate tibial nail insertion without reaming as part of protocol-driven management provide a safe and effective treatment for open tibia fractures?
STUDY DESIGN:Prospective cohort.
...SETTING:Level 1 trauma center.
PATIENTS:A consecutive series of 161 patients with Gustilo grade I-IIIb open tibia fractures.
INTERVENTION:Emergent incision and debridement of the wound with immediate tibial nail insertion without reaming, repeat incision and debridement, and soft-tissue coverage within 14 days.
MAIN OUTCOME MEASUREMENTS:Time to union, number of secondary procedures performed to obtain union, implant failures, and the type and incidence of complications.
RESULTS:One hundred and forty-three fractures were followed to union. Follow up averaged 2.2 years (0.6-5.5 years). Seventy-six fractures united in less than 6 months, 35 took between 6 and 9 months, and 32 took longer than 9 months. Twenty-five additional procedures were needed to obtain union in 16 of the delayed unions (12 nail exchanges, 4 bone grafts, 9 dynamizations). Complications included 3 patients with cellulitis, 1 superficial infection, 4 deep infections (1 grade I, 2 grade II, 1 grade IIIb), 3 loose screws, 2 broken screws, 5 malunions greater than 5 degrees, and 30 patients with decreased ankle motion when compared with the uninjured side. Not counting the ankle loss of motion, 18 complications occurred in 143 fractures (13%). Twenty-nine patients (20%) had complaints of minor knee pain and 30 (21%) had occasional fracture site pain after activity despite clinical and radiographic evidence of union. Eleven patients (8%) considered themselves completely disabled. Five patients were not treated by the standard protocol and are not included in the previously listed statistics; 3 were grade IIIB that did not have adequate coverage by 14 days, and 2 were grade II injuries that did not have a second debridement. Four of these 5 patients developed a complication.
CONCLUSIONS:Protocol-driven management emphasizing meticulous soft-tissue management and the use of immediate tibial nailing without reaming appears to be safe and effective in the treatment of open tibia fractures. The deep infection rate for the patients who were treated by protocol was 3% and the implant failure rate was lower than has been previously reported, most likely attributable to attempts to obtain cortical contact and avoid fracture gaps. Overall satisfaction was good, but approximately 41% of the patients had complaints of knee or fracture site pain or both well after union.
BackgroundThe stability of the ankle joint is provided by the medial and lateral malleoli and ligaments. Recent studies of cadaveric ankles have demonstrated that injury to the medial structures of ...the ankle is necessary to allow lateral subluxation of the talus after fracture. However, cadaveric models are limited by the fracture pattern chosen for the model. We sought to investigate the competency of the deltoid ligament in vivo in patients with an operatively treated bimalleolar ankle fracture.MethodsTwenty-seven patients with a bimalleolar ankle fracture were evaluated. In each patient, the medial malleolus was anatomically reduced and fixed. A radiograph of the ankle was then made with application of an external rotation load to the joint. All lateral malleolar injuries were then reduced and fixed. The radiographs were evaluated for restoration of the competence of the deltoid ligament according to established criteria.ResultsSeven (26 percent) of the twenty-seven patients had radiographically evident incompetence of the deltoid ligament after medial malleolar fixation. This finding was associated with a small medial malleolar fragment.ConclusionsIn bimalleolar fractures, the medial injury may be an osseous avulsion, leaving the deltoid intact on the displaced fragment, or it may be a combination of ligamentous and osseous injury with disruption of the deep portion of the deltoid ligament.
BackgroundThe number and quality of well-designed scientific studies in the orthopaedic literature are limited. The purpose of this review was to determine the methodological qualities of published ...meta-analyses on orthopaedic-surgery-related topics.MethodsA systematic review of meta-analyses was conducted. A search of the Medline database provided lists of meta-analyses in orthopaedics published from 1969 to 1999. Extensive manual searches of major orthopaedic journals, bibliographies of major orthopaedic texts, and personal files identified additional studies. Of 601 studies identified, forty met the criteria for eligibility. Two investigators each assessed the quality of the studies under blinded conditions, and they abstracted relevant data.ResultsMore than 50% of the meta-analyses included in this review were published after 1994. We found that 88% had methodological flaws that could limit their validity. The main deficiency was a lack of information on the methods used to retrieve and assess the validity of the primary studies. Regression analysis revealed that meta-analyses authored in affiliation with an epidemiology department and those published in nonsurgical journals were associated with higher scores for quality. Meta-analyses with lower scores for quality tended to report positive findings. The meta-analyses that focused upon fracture treatment and degenerative disease (hip, knee, or spine) had significantly lower mean quality scores than did meta-analyses that examined thrombosis prevention and diagnostic tests (p < 0.05).ConclusionsThe majority of meta-analyses on orthopaedic-surgery-related topics have methodological limitations. Limitation of bias and improvement in the validity of the meta-analyses can be achieved by adherence to strict scientific methodology. However, the ultimate quality of a meta-analysis depends on the quality of the primary studies on which it is based. A meta-analysis is most persuasive when data from high-quality randomized trials are pooled.
Displaced acetabular fractures are a challenging problem. In contradistinction to most conditions in which surgery is based on specific operative indications, displaced acetabular fractures should be ...considered an operative problem unless specific criteria for nonoperative management are met. These include a congruent hip joint on the anteroposterior and oblique (Judet) radiographs, an intact weight-bearing surface (as defined by roof arc and subchondral arc measurements on computed tomographic scans), and a stable joint. The final decision about the treatment method must also consider the patients functional demands, expectations, and physical condition and the physicians experience and institutional support for dealing with this type of injury. Displaced both-column fractures with secondary congruence may have better results than other displaced fractures. In older patients, nonoperative management may be effectively utilized. Understanding the current criteria for effective use of nonoperative treatment will help the surgeon make these difficult decisions.
Percutaneous fixation of calcaneal fractures has limited indications. It is most useful for tongue-type fractures in which the displaced portion of posterior facet remains intact to the tuberosity. ...This allows the tuberosity to be used as a reduction tool for the posterior facet. The technique has been used successfully in 41 patients. In the current study, the indications and technique are reviewed in detail.
OBJECTIVES:To evaluate the reduction and outcome of selected intraarticular calcaneal fractures treated with percutaneous Essex-Lopresti reduction and fixation.
DESIGN:Prospective consecutive series.
...SETTING:Level one trauma center and tertiary university hospital.
PATIENTS/PARTICIPANTS:Twenty-six consecutive patients with an Essex-Lopresti tongue-type, Sanders type 2C calcaneus fracture.
INTERVENTION:Modified percutaneous Essex-Lopresti type spike reduction and fixation of the posterior facet.
OUTCOME MEASUREMENTS:Clinical and radiographic analysis.
METHODS:Twenty-six consecutive patients with calcaneal fractures meeting the criteria had an attempted percutaneous reduction performed under fluoroscopic control with the patient in the lateral position. Twenty-three of the twenty-six feet had an acceptable reduction, and the remaining three were treated with open reduction and internal fixation (ORIF). The first seventeen cases were stabilized by two Steinmann pins, which were removed at ten to twelve weeks. The last six cases were fixed with two cannulated 6.5-millimeter screws, which were left in place. Early motion was encouraged in all cases
RESULTS:Of the twenty-three patients with an acceptable reduction, twenty had no angulation between the posterior facet of the talus and the calcaneus and three had <5 degrees. The tuberosity reduction was <5 degrees in seventeen cases and <10 degrees in all cases. The calcaneal height was restored to normal in twenty cases, and the width (axial view) averaged 119 percent of the contralateral side. Follow-up averaged 2.9 years. Using the Maryland foot score there were twelve (55 percent) excellent, seven (32 percent) good, and three (13 percent) fair results.
CONCLUSIONS:The Essex-Lopresti spike reduction is a useful method for the treatment of tongue-type Sanders type 2C fractures of the calcaneus. Results are superior to those in previous series of intraarticular fractures treated with ORIF.
BackgroundAlthough an investigator may limit bias through randomization, concealment of patient allocation, and blinding, the results of randomized trials may be less convincing when the sample size ...is not sufficiently large to reveal a true difference between treatment groups. When the sample size is small, randomized trials are subject to beta errors (type-II errors)—that is, the probability of concluding that no difference between treatment groups exists when, in fact, there is a difference. The purpose of this study of randomized trials involving fracture care published between 1968 and 1999 was twofold(1) to evaluate type-II error rates and study power (1 - β) for the primary outcomes and (2) to identify whether investigators clearly identified the primary and secondary outcomes.MethodsTo be eligible, studies were required to (1) be published in English, (2) be described as a randomized trial, (3) involve the care of adult patients with fractures, treated either operatively or nonoperatively, and (4) contain sufficient outcome information to enable study power to be calculated. Computer database searches were performed independently by two investigators to identify all potentially relevant study titles. Additional strategies to identify articles included (1) hand searches of selected orthopaedic journals from 1989 to 1999, (2) searches of the bibliographies of potentially relevant articles, and (3) review by content experts to identify missing studies. For each study, a standard power calculation was performed on the primary and secondary outcomes. For those studies in which the primary outcome was not explicitly reported, the most clinically relevant measure was chosen by consensus. Acceptable study power was agreed a priori to be 80% (type-I error of £ 0.20).ResultsWe identified 620 potentially relevant citations from MEDLINE, of which only 187 were potentially eligible. We identified nine more articles with other searches, and application of the eligibility criteria to the 196 articles eliminated seventy-nine. Thus, we analyzed 117 studies in which a total of 19,942 patients with orthopaedic trauma had been randomized. Sample sizes ranged from ten to 662 patients (mean and standard deviation, 95 79 patients). The majority (34%) of trials involved the treatment of hip fractures. The mean overall study power among the 117 trials was 24.65% (range, 2% to 99%). The type-II error rate for primary outcomes was 90.52%.ConclusionsMean type-II error rates in the orthopaedic trauma trials that we analyzed exceeded accepted standards. Investigators can reduce type-II error rates by performing power and sample-size calculations prior to conducting a trial.
