Femoral fractures are common in children, accounting for 1% to 2% of pediatric fractures1,2. The goals of treatment are to facilitate fracture-healing and to restore function, and these goals have been successfully met in most cases, regardless of the treatment method used. Treatment methods vary, depending on patient age and type of fracture. For patients two to six years old, methods include double full-leg spica casting3-5, one and one-half-leg spica casting6-8, traction alone9-12, traction followed by spica casting13,14, traction pin incorporated into the spica cast3, and surgical options (e.g., external fixation15-19, plating20-22, and flexible nailing23-25). The American Academy of Orthopaedic Surgeons has recently recommended the use of spica casting instead of surgical treatment for patients six months to five years old26 because it avoids general anesthesia, complications of open surgery, a surgical scar, and a second procedure to remove hardware. Permanent complications are rare with careful application of a spica cast3-8, but this method does have some disadvantages, such as the possibility of skin problems and compartment syndrome27 and the hardships for the child, the family, and the community28.
There are several different types of spica casts. As reported by Firor4, double-leg spica casting was used as early as 1898 by Harvey Cushing at The Johns Hopkins Hospital. Historically, single-leg spica casting has also been used as a treatment method for pediatric diaphyseal femoral fractures9. Many contemporary authors have recommended immediate double-leg spica casting for the treatment of diaphyseal femoral fractures in patients six months to six years old6,8,29-31, but there has been some interest in the use of single-leg spica casting for these patients.
We conducted a prospective, randomized controlled study comparing double-leg and single-leg spica casting for diaphyseal femoral fractures in healthy patients who were two to six years old. We hypothesized that such patients can be effectively treated with single-leg spica casting and that such treatment would result in easier patient care and better patient function during treatment.
Institutional review board approval was obtained for this study. This study was registered in the ClinicalTrials.gov public trials registry (NCT01293916).
Patient Population
Over a thirty-nine-month period from May 2006 through August 2009, we prospectively assessed patients two to six years old who had been admitted to our institution with an acute diaphyseal femoral fracture for eligibility to be enrolled in our study. We excluded patients who had an underlying bone disorder, a neuromuscular condition, or a fracture showing ≥25 mm of shortening on radiographic assessment at any point on the day of initial presentation. Guardians of eligible patients were asked to give consent for enrollment into the study, and consent forms were signed in the emergency department.
Of the fifty-four patients (fifty-four fractures) eligible for inclusion, two were not enrolled because of parental refusal; the remaining fifty-two patients (fifty-two fractures) formed our study group and were assigned to one of the two treatment groups via random selection of an opaque envelope that contained the word “single” or “double.” For this study, a single-leg cast was defined as a spica cast extending to the toes of the injured leg and stopping above the hip of the noninjured leg, and a double-leg cast was defined as a cast extending to the toes of the injured leg and extending to just above the knee of the noninjured leg. Both casts included the foot of the injured leg. The double-leg group consisted of twenty-eight patients (nineteen boys and nine girls; average age, 3.73 years [range, 2.01 to 5.97 years]). The single-leg group consisted of twenty-four patients (sixteen boys and eight girls; average age, 3.67 years [range, 2.05 to 6.92 years]).
Procedures
With the assistance of emergency department physicians and nursing staff as well as one or more junior orthopaedic residents (postgraduate year two, three, or four), fracture reduction was done and casts were applied by an attending pediatric orthopaedic surgeon or chief orthopaedic resident. Conscious sedation was provided by the staff in our American College of Surgeons-designated level-I pediatric emergency department. A standardized protocol was used for cast application as follows:
A stockinette was applied to the patient’s torso and injured leg to the toes (as well as above the knee of the uninjured limb of patients randomized into the double-leg group). Before this step, regional anesthesia with a hematoma block or femoral nerve block is an option.Webril (Kendall) was rolled around the injured leg, making sure that the knee remained flexed 60° to 75° at all times to prevent bunching of the Webril behind the knee.The injured leg was wrapped in a long leg fiberglass cast with a gentle valgus mold applied at the fracture site. The goal was to apply the cast with the femoral fracture reduced in a slightly valgus position because it has been our observation that, in children, there is a tendency for the fracture site to shift into some degree of varus over time if the cast is applied in a neutral varus/valgus orientation. The medial-lateral dimension of the thigh segment was narrowed as much as possible by molding.The patient was then placed onto a spica table.A pad was placed between the stockinette and the chest to provide space for the child to breathe after the cast set.Webril was then applied to the torso (and to the uninjured leg to just above the knee for children randomized into the double-leg group).The torso to the nipple line (and the uninjured leg to just above the knee in the double-leg group) was then wrapped in fiberglass, with as many passes across the hip on the injured side as possible to provide as much rigidity as possible at that joint.Sometimes a strut consisting of approximately eight layers of fiberglass was applied to the cast across the hip on the injured side to provide more strength to the cast.The stockinette edges were wrapped down, and a final layer of fiberglass wrap in a color or pattern chosen by the patient was applied.The cast surface was smoothed out with hand soap.The edges of the cast were inspected, and any rough edges were removed with the cast saw or trauma shears.The edges of the cast were pedaled with tape.
To facilitate subsequent patient placement into car seats, the casts were placed with the hips and knees flexed 60° to 75°. The patients were monitored in the emergency department following cast application until they were fully awake. At this point, patients without other injuries requiring hospitalization or the need for a workup to investigate the possibility of child abuse were discharged home after the parents were given a color pamphlet with instructions for spica cast care and after a discussion about recognizing compartment syndrome and returning immediately should such symptoms develop. For any patient who could not fit into the car seat that was in the parents’ automobile, a special car seat or harness was provided at no charge by the hospital. Wheelchairs were made available to families.
Radiographs were obtained on initial presentation to the emergency room, after fracture reduction and cast application, at the time of the first follow-up (approximately seven to fourteen days after injury), and then at two-week intervals until the cast was removed. To remain in the study, patients had to have radiographic follow-up in the clinic or the parents had to be contacted to complete the surveys. One patient was unable to have radiographs at our institution because of insurance restrictions so those radiographs could not be read, and the parents of three patients only partially completed the surveys and were not reachable with the contact information that we had. However, the available data on these patients were included in the study.
On the day of cast removal, two surveys were completed by the parents. The first was a ten-question custom-written survey formulated by our four pediatric orthopaedic fellowship-trained attending surgeons that assessed ease of patient function and caregiving (Fig. 1). This questionnaire, specifically designed for this study, had yes/no responses (e.g., “Did the cast need trimming or modification?”) or incorporated a visual analog scale for rating difficulty from 1 to 10 (e.g., “How easy was it for your child to leave the family residence or yard?”). The second survey was the performance version of the Activities Scale for Kids (hereinafter termed the “activities survey”)32. The activities survey assesses a patient’s overall abilities to carry out basic daily functions, such as brushing teeth, playing with other children, or getting dressed. It was designed to assess the function of the child in the week before cast removal32. Each function in the activities survey was graded (0 to 4 points) with respect to the child’s ease of performance. The highest possible total score is 120 points, and the final score was reported as a percentage of the highest possible score (X/120 × 100%). Surveys were filled out in the clinic, mailed to families, or completed over the telephone after the casts had been removed. All patients had radiographic or written survey data for comparison between groups.
Of the twenty-four patients in the single-leg group, one could not have radiographs made at our institution; therefore, only the custom and activities surveys were evaluated for that child. In the single-leg group, twenty-one custom surveys and twenty-one activities surveys were available for analysis. Of the twenty-eight patients in the double-leg group, twenty-seven had radiographs, twenty-three had custom surveys, and sixteen had activities surveys for comparison. With the contact information provided, it was not possible to reach the parents of the patients in either group who did not have custom surveys, activities surveys, or both. No family enrolled in the study refused to complete the surveys.
Statistical Analysis
Single-tailed Student t tests were used to compare the means of the two treatment groups, and significance was set at p < 0.05.
Source of Funding
No funding was received in support of this study.
No patient developed compartment syndrome, major skin problems, superior mesenteric artery syndrome, or other complications.
All patients enrolled in the study could verbally communicate or walk prior to the fracture. Per parental report, the patients in the single-leg spica cast group required their parents to miss significantly fewer days from work (average, more than eight fewer per child), as compared with those in the double-leg group; were significantly more likely to fit into their car seats; and were significantly more comfortable sitting in chairs as interpreted by their parents (Table I). The patients in the single-leg cast group also displayed a trend toward being more likely to walk. There were no significant differences in cast treatment time, femoral shortening, femoral angulation in the coronal or sagittal plane, independent movement, keeping the child or cast clean, or activities survey scores.
One child randomized into the double-leg group who initially had <25 mm of shortening had 25 mm of shortening seen on radiographs obtained immediately after fracture reduction and cast application in the emergency department. This child underwent fracture reduction and submuscular plating and was removed from the study per study protocol. One child randomized to the single-leg group underwent fracture manipulation under anesthesia and recasting into a single-leg spica after the first follow-up visit fourteen days after injury for treatment of loss of fracture reduction with resultant 20° of varus and 31° of procurvatum. This child ultimately had healing with 8° of varus, 0° of procurvatum, and no shortening. She was doing well clinically at four months after injury.
Notably, the parents of two patients requested conversion of the double-leg spica cast to a single-leg spica; both families reported that the single-leg cast allowed easier patient care. Data from these patients were included with those in the double-leg group because it was our intention to treat them with a double-leg cast. It is unclear if there was any effect on the overall results.
To our knowledge, there have been no studies comparing single-leg and double-leg spica casting for the treatment of femoral fractures. We found that the single-leg-cast group had three significant differences from the double-leg group: fewer parental workdays missed, more comfort sitting in chairs, and better car-seat accommodation. Thus, single-leg spica casts may provide useful advantages, with no apparent loss of fracture control, that orthopaedic surgeons should discuss with their patients’ parents.
This study had several limitations. First, patients were not followed beyond cast removal and therefore final function was not assessed. Because patients may limp for many months and because it might take up to three years for angulation to reach its maximum correction10,33, the ideal follow-up time would be one year or more after injury.
The surveys were intended to be completed on the day the cast was removed, but because the staffing and locations of the clinics were inconsistent, many of the surveys were completed by mail or telephone. One individual from our group contacted all of the families by telephone for completion of the surveys when all other attempts had failed. Families were asked to think back to the child’s function in the week before cast removal. Because of the elapsed time, families may have forgotten exactly what they experienced while caring for their injured child. Surveys were subject to the immediate mood of the person being surveyed at that specific time. With a large enough sample size, the mood bias would affect both groups equally. We recognize that substantial bias could have been introduced by the fact that the surveys were conducted at different points of time in the patients’ treatment and that one patient who was surveyed had follow-up outside our institution so that radiographs were not included. In addition, a substantial percentage of patients’ parents did not fill out the performance questionnaire.
The radiographs were often difficult to interpret even in the early stages of healing because of callus formation, which sometimes made evaluation of length difficult. The day of presentation is the best time for deciding whether to accept the amount of shortening or to choose another method of treatment that controls shortening more effectively, such as plating, flexible intramedullary nailing, or use of external fixation34.
The families of the two patients treated with both casting methods may have been biased in their conclusions that single-leg casts were much easier to manage because the children had been in the double-leg spica casts at the beginning of their treatment, when care is most difficult. For example, most or all of the children who walked during cast treatment were able to do so only in the last week or two of that treatment. Both families did, however, report definitively easier care of their child with the single-leg cast.
We did not control for the families’ socioeconomic status. Some bias could have been introduced to this study on the basis of the abilities of the preschool or elementary school to accommodate a child wearing a spica cast. Families with a stay-at-home parent may not have required any loss of work days for the care of their children.
We believe that it is important to apply the cast with the femoral fracture reduced in slight valgus because there is a strong tendency for the children to have an increase in varus following the initial reduction and casting. We recognize that there is disagreement about the amount of angulation that is acceptable at the time of follow-up. We believe that length should be carefully controlled because it is less easily corrected by remodeling and more difficult to surgically correct later. Therefore, it is our opinion that no more than 25 mm of shortening should be accepted on the day that the child presents to be treated.
In conclusion, single-leg spica casting can be used safely and effectively for patients two to six years old. Compared with double-leg spica casting, single-leg casting facilitates patient care and may result in improved child function during the cast treatment period.
Note: The authors acknowledge the contributions to this study made by Leanne Sprankle, BSN, Elaine P. Henze, BJ, ELS, Sara J. Cleary, BS, Greg M. Osgood, MD, the Johns Hopkins pediatric emergency department staff, and especially the Johns Hopkins orthopaedic residents.