The effect of coronal plane angulation on patient reported outcome measures of operatively treated distal femur fractures: A multi-center prospective evaluation.

OBJECTIVES: The goal of this trial was to determine whether coronal plane angulation affects functional and clinical outcomes after the fixation of distal femur fractures. DESIGN: Multicenter, randomized controlled trial SETTING: 20 academic trauma centers PATIENTS/PARTICIPANTS: 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. INTERVENTION: Lateral locked plating or retrograde intramedullary nailing MAIN OUTCOME MEASUREMENTS: 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. RESULTS: 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. CONCLUSIONS: 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.

Outcome of periprosthetic distal femoral fractures following knee arthroplasty.

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.(1) 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 (χ(2)=0.05). No difference in infection rate was found for submuscular procedures compared with open procedures (χ(2)=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.(2) was achieved in 83%. Using Kristensen's(1) 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.

The use of calcium phosphate bone cement in fracture treatment: a meta-analysis of randomized trials

Structured abstract from an article published on Journal of Bone and Joint Surgery which compares the effects of calcium phosphate bone cement with alternatives on functional and radiographic outcomes in adults with metaphyseal fractures of the upper and lower extremities.

Open fractures of the tibia treated by immediate intramedullary tibial nail insertion without reaming: a prospective study.

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.

Type-II error rates (beta errors) of randomized trials in orthopaedic trauma.

BACKGROUND: Although 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 - beta) for the primary outcomes and (2) to identify whether investigators clearly identified the primary and secondary outcomes. METHODS: To 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 > or = 80% (type-I error of < or = 0.20). RESULTS: We 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%. CONCLUSIONS: Mean 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.

Overtightening of the ankle syndesmosis: is it really possible?

BACKGROUND: Many surgeons and orthopaedic references recommend that fixation of a disrupted distal tibiofibular syndesmosis be performed with the ankle in dorsiflexion to avoid overtightening and subsequent restriction of ankle dorsiflexion. This recommendation is based in large part on one cadaveric study without clinical correlation. The purpose of the present study was to examine whether overtightening of the syndesmosis limits maximal ankle dorsiflexion. METHODS: Nineteen cadaveric ankles were used for the study. Each ankle was tested for the initial range of motion after release of the Achilles tendon proximal to the ankle joint. All capsular and ligamentous structures remained intact. Kirschner wires were placed in the tibia and talus. The angle between the wires with the ankle maximally dorsiflexed was measured before and after syndesmotic compression. Syndesmotic compression was achieved with a 4.5-mm lag screw with the ankle in plantar flexion. RESULTS: There was no difference between the values for maximal dorsiflexion before and after syndesmotic compression. CONCLUSIONS: Syndesmotic compression in and of itself does not diminish ankle dorsiflexion in a cadaveric model. CLINICAL RELEVANCE: Maximal dorsiflexion of the ankle during syndesmotic fixation is not required in order to avoid loss of dorsiflexion. It is likely that the most important aspect of syndesmotic fixation is anatomic reduction of the syndesmosis and that the degree of ankle dorsiflexion during fixation is not important.

Tibial portal placement: the radiographic correlate of the anatomic safe zone.

OBJECTIVE: To identify the radiographic correlate of the anatomic safe zone for tibial portal placement. DESIGN: Cadaveric, anatomic, and radiographic study using twenty cadaveric knees. Kirschner wires were placed in the anatomic safe zone. Anteroposterior and lateral radiographs were taken to evaluate the portal placement. SETTING: Anatomy laboratory. OUTCOME MEASUREMENTS: Radiographic measurements of Kirschner wires placed in the anatomic safe zone. RESULTS: The safe zone for tibial nail placement as seen on radiographs is just medial to the lateral tibial spine on the anteroposterior radiograph and immediately adjacent and anterior to the articular surface as visualized on the lateral radiograph. There is some variance on the anteroposterior radiograph but no variance on the lateral radiograph. CONCLUSIONS: The placement of tibial nails in the superior portion of the tibia in the documented position generates the least risk to the intraarticular structures of the knee.

Lag screw only fixation of the lateral malleolus.

OBJECTIVES: To evaluate the use of lag screw only fixation of noncomminuted oblique fractures of the lateral malleolus in patients younger than fifty years of age. DESIGN: Prospective evaluation. SETTING: Level I trauma center. PATIENTS AND PARTICIPANTS: Forty-seven ankle fractures with simple oblique patterns and no comminution that were long enough to accept two lag screws placed at least 1 centimeter apart were prospectively evaluated. All patients were younger than fifty years of age. There were twenty-three ligamentous SE4, eighteen bimalleolar SE4, and six PE4 fractures. INTERVENTION: Open reduction and internal fixation with lag screw only fixation of the lateral malleolus. MAIN OUTCOME MEASUREMENTS: Radiographic and clinical outcome parameters were compared with those of a cohort of patients previously treated at the same institutions using different techniques. RESULTS: Thirty-five patients' ankles were fixed with two lag screws, ten with three lag screws, and two with four lag screws. The incision for lag screw placement was 30 percent shorter and slightly more anterior than that in the comparison group. No patient lost reduction and there were no soft-tissue complications in the group. Follow up averaged 1.6 years for forty-two patients. One patient (2 percent) had complaints of lateral pain in the study, compared with 17 percent in the plate group. No patient fixed with lag screws had palpable hardware, as compared with 56 percent in the plate group. None had any restrictions in shoe wear, as compared with 15 percent in the plate group. No patient required screw removal, as compared with 31 percent in the plate group. There was no difference in radiographic outcome between the two groups. CONCLUSIONS: Lag screw only fixation is a useful and successful method for appropriately selected lateral malleolar fractures.

Displaced acetabular fractures: indications for operative and nonoperative management.

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.

Meta-analyses in orthopaedic surgery. A systematic review of their methodologies.

BACKGROUND: The 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. METHODS: A 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. RESULTS: More 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). CONCLUSIONS: The 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.

Tension wire position for hybrid external fixation of the proximal tibia.

OBJECTIVE: To compare a new configuration of proximal wires for hybrid external fixation with the standard configuration. DESIGN: Biomechanical testing of five matched pairs of fresh cadaveric tibia. INTERVENTION: The authors compared the standard tension wire configuration of the three proximal wires with a more sagittal orientation of the oblique wires. A second study compared the new configuration with two wires and an offset half-pin. A two-centimeter segmental defect was created just distal to the tibial tubercle and the tibias fixed in a Montecelli Spinelli (Howmedica, NJ, U.S.A.) hybrid frame. The constructs were biomechanically tested using an Instron servohydraulic biaxial testing machine. RESULTS: There was a significant 67 percent decrease in displacement during anterior posterior bending and a significant 40 percent decrease in displacement in posterior bending with the new configuration compared with the standard configuration (p < 0.05). The differences in stability in all other testing modes were not significant. There was no significant difference between the new configuration and the two wire and off-set half-pin configuration. CONCLUSION: We recommend anterior placement of the oblique tension wires in the proximal tibia to more effectively resist bending in the sagittal plane, which is the most common deforming force on proximal metaphyseal fractures.

Antegrade or retrograde reamed femoral nailing. A prospective, randomised trial.

Retrograde femoral nailing is gaining in popularity. We report a prospective, randomised comparison of antegrade and retrograde procedures in 68 patients with 69 fractures of the femoral shaft. All nails were inserted after appropriate reaming. There was no difference in operating time, blood loss, technical complications, size of nail or reamer, or transfusion requirements. There were more problems of length and rotation using a retrograde technique on a radiolucent table than with an antegrade approach on a fracture table. All fractures in both groups healed and there was no difference in the time taken to achieve union. Although retrograde nailing is a promising technique the skills required need practice. A longer period of follow-up is necessary to determine whether there are long-term problems in the knee after such surgery.

Acetabular fractures in children and adolescents.

A retrospective study of 29 acetabular fractures in children 2 to 16 years of age with an average followup of 14 years is presented. Nineteen patients had an additional dislocation of the femoral head and 14 patients had an associated neurologic injury. Surgical treatment was performed in 16 patients and consisted of open reduction and internal fixation in 14 patients and a simple arthrotomy in two patients. Thirteen patients were treated nonoperatively with traction or bedrest. The outcome was satisfactory in all patients with undisplaced fractures and fractures with disruption of a small fragment. Eight patients with linear fractures with instability all were treated surgically. All but one of the patients had a satisfactory functional outcome; one patient had early degenerative changes develop after an open pelvic and acetabular fracture. Patients with central fractures and dislocations had a relatively poor outcome, and congruency was achieved in only one of the four patients who were treated surgically. Results may deteriorate with time, as was seen when the results of the current study were compared with those published 10 years previously.

Accidental and nonaccidental femur fractures in children.

A retrospective review of 207 patients younger than 6 years of age who sustained nonpathologic diaphyseal femur fractures was done, which emphasized the characteristics of accidental versus nonaccidental injury. There were 214 fractures in 123 boys and 83 girls (the gender of one patient was unknown). The average age of the patients was 2.73 years. Mechanisms of injury were pedestrian struck by a car (62 patients), falls (92 patients), and motor vehicle accidents (10 patients). Nineteen patients did not have a history of trauma. Seventy-six cases were investigated for child abuse. The results of 13 investigations were positive. Overall, the morphologic features of the fractures were transverse (38%), spiral (27%), and oblique (17%). In the investigated group, 27% of the fractures were transverse, 39% were spiral, and 15% were oblique. In those cases with positive results of the investigation, 36% of the fractures were transverse, 36% were spiral, and 7% were oblique. Although transverse fractures are most common in accidental and nonaccidental injuries, many practitioners think spiral fractures are pathognomonic of abuse. The current data show that although spiral fractures were less common than transverse fractures overall, and no more common in the cohort of patients in whom the results of the child abuse investigations were positive, they were overrepresented in the cohort that was investigated. This suggests that spiral fractures are viewed as particularly suspicious, which may lead to missed cases of nonaccidental injury in children with transverse fractures.

Ender rod fixation of femoral shaft fractures in children.

Ender rod fixation for femoral shaft fractures in children was evaluated in a prospective study at two Level 1 trauma centers. Fifty-seven fractures in 52 patients were evaluated. Criteria for inclusion in the study included age younger than 14 years, femoral shaft fractures occurring in the middle 3/5, canal size greater than 7 mm, and parental consent. Hip and knee motion, gait, leg length discrepancy, and rotational asymmetry were evaluated by clinical examination. Standard radiographs were used to measure any residual angulation. A subset of patients whose injuries occurred more than 12 months previously was evaluated using scanograms. Followup averaged 20 months. There were no delayed unions and all fractures healed within 12 weeks. Clinically significant leg length discrepancy, malunion, or loss of motion did not occur. Functional results were excellent and complications were minor. Ender rod fixation of femur fractures in children allows the advantages of surgical fixation with minimal risk of complications.

Superior gluteal artery in the extended iliofemoral approach.

OBJECTIVE: To determine the incidence of superior gluteal artery injury following fracture of the acetabulum and to determine whether the combination of a superior gluteal artery injury and the use of an extended iliofemoral approach to the acetabulum creates abductor muscle necrosis. DESIGN: Prospective protocol, consecutive cases. SETTING: A consecutive series from the referral practice of the senior author plus seven cases from the practices of two other authors. PATIENTS: Two hundred twenty-seven patients with fractures of the acetabulum were treated operatively between November 1992 and January 1995. Forty-one were treated with the use of the extended iliofemoral approach. Preoperative angiograms were not performed for any of the patients. All fractures involved the posterior column, and all but two fractures had displacement of the greater sciatic notch. The average displacement of the notch was 2.5 centimeters (range 6 to 60 millimeters). INTERVENTION: All patients were treated with open reduction and internal fixation via the extended iliofemoral approach. Intraoperative Doppler examination of the superior gluteal artery was performed before and after reduction and fixation of the posterior column. MAIN OUTCOME MEASURE: Wound complications, abductor manual muscle testing, hip range of motion. RESULTS: Pulsatile flow was confirmed in forty of forty-one patients. All patients were followed for a minimum of six months with an average follow-up of 1.4 years. At most recent follow-up, no patients had evidence of complete loss of abductor function. Sixty-three percent of patients had achieved Grade 4 of 5 motor strength, and 25 percent of them had achieved normal motor strength. CONCLUSIONS: No instances of superior gluteal artery laceration and only one instance of superior gluteal artery thrombosis were encountered in these forty-one patients despite significant fracture displacement involving the sciatic notch. The incidence of superior gluteal artery injury was significantly less than would be expected from previous studies. Massive abductor necrosis resulting from superior gluteal artery injury combined with an extended approach has been described primarily in animal and cadaver studies. Although arteriograms are useful in the control of hemodynamic instability, we cannot support the recommendation of preoperative angiographic study of all patients undergoing acetabular fracture surgery via an extended approach. In one case, an extended iliofemoral approach was tolerated in a patient with absent superior gluteal artery flow.

Competence of the deltoid ligament in bimalleolar ankle fractures after medial malleolar fixation.

BACKGROUND: The 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. METHODS: Twenty-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. RESULTS: Seven (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. CONCLUSIONS: In 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.

Percutaneous treatment of calcaneal fractures.

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.