Initial clinical experience with a new biointegrative cement for vertebroplasty in osteoporotic vertebral fractures.

SUMMARY: Polymethylmethacrylate, as a widely used material for vertebroplasty, has several drawbacks such as heat development and high allergenic potential. In order to avoid these drawbacks ceramic cement materials have been developed. The purpose of this study was to evaluate a new biointegrative material for vertebroplasty in osteoporotic vertebral fractures regarding pain relief, safety aspects and technical feasibility. The injectable bone substitute Cerament(TM) SpineSupport has been developed for vertebroplasty of osteoporotic vertebral fractures. The aim of the product is to provide mechanical stability by cured calcium sulfate dehydrate during a period of several weeks and to act as an osteoconductive support by hydroxyl apatite particles. Inclusion criteria were a stable single vertebral fracture at levels Th5 to L5, verified by CT and MRI, and not older than four weeks, in osteoporotic patients aged 60 years or older. Bipedicular vertebroplasty technique was used. Follow up included CT directly after treatment and after two month and pain assessment (VAS) pre and post procedure after two weeks and one month. Seven patients (age range 62 - 96 years, mean 73.9, five women, two men) were treated at levels T 8 (n=1), T 12 (n=4) and L1 (n=2). The average injected volume was 1.9 ml (range 0.2-4 ml). No material or procedure-related complications were observed. An average height loss of the treated vertebral bodies of 3.6 mm (range 1.5-5.4) was seen two months after treatment as compared to pre-treatment CT. Pain assessment by VAS resulted in an improvement from mean 69 prior treatment to 37 the day post treatment, 42 after two weeks and 30 after one month. Initial results indicate that Cerament(TM) SpineSupport is safe and effective in the treatment of acute osteoporotic vertebral body fractures. Further studies with long-term follow-up are needed to confirm these results and to prove the concept of osteoconduction with hydroxyl apatite particles.

Frequent complications in distal femoral osteotomy: a retrospective 8 year multicenter follow-up.

A total of 32 distal femoral osteotomies performed between 1971 and 1993 were evaluated, with a follow-up of 8 (2-23) years. Indications were lateral gonarthrosis in 23 cases (group I), and there were a variety of other indications in 9 cases (group 2). Twenty-six of the patients were submitted to revision surgery. Eleven operations were performed as a result of complications, such as pseudarthrosis (5), deep infection (3), and stiff knee (3). The remaining 16 were removals of fixation devices and they were not considered complications. Clinical results were evaluated based on different clinical scores (HSS, Lysholm, and Tegner) and NHP (Nottingham Health Profile), and there were 10 cases with good or excellent results. Results were better if the postoperative HKA angle (Hip-Knee-Ankle) was within 0-8 degrees of varus. As accuracy of correction is of importance, and serious complications frequent, it is important to entrust cases such as these to the care of surgeons with a good knowledge of the surgical technique.

Impaired quality of life 10 to 20 years after primary hip arthroplasty.

The functional results in terms of quality of life 10 to 20 years after cemented total hip arthroplasty due to primary arthrosis were evaluated in 187 patients with nonrevised hips by use of the Nottingham Health Profile questionnaire. Function was impaired compared with age- and sex-matched random control subjects.

Orthosis as prognostic instrument in lumbar fusion: no predictive value in 50 cases followed prospectively.

To evaluate pain relief in a lumbar orthosis as a predictor for good clinical results after solid fusion, all patients scheduled for such a surgical procedure were preoperatively encouraged to use an orthosis, soft or rigid, for 3 weeks. Grade of back pain relief as a percent using the orthosis was assessed by the patients and was registered before surgery. After surgery, at 1-year follow-up, patients with nonunion demonstrated radiographically were excluded from the series. Thus, 50 patients with solid fusion could be identified and followed for at least 2 years prospectively. At follow-up these 50 patients graded the pain relief induced by the fusion. In the preoperative corset test, 31 patients experienced significant back pain relief, meaning a reduction of at least 50%. No applicable correlation was found, however, between outcome in this corset test and the eventual clinical result expressed as improvement/no improvement after solid fusion. The two types of orthoses did not differ in this aspect. We conclude that the orthosis, rigid or soft, is not a useful instrument when selecting patients for lumbar fusion.

Function after primary hemiarthroplasty and secondary total hip arthroplasty in femoral neck fracture.

Four to 12 years after primary treatment of femoral neck fracture with hemiarthroplasty in a group of Finnish patients and secondary total hip arthroplasty as a salvage procedure for healing complication after primary osteosynthesis in a group of Swedish patients, function was classified and the Nottingham Health Profile questionnaire was applied. The two groups were comparable with regard to age, sex, and social status. The patients with secondary total hip arthroplasty used walking aids to a lesser extent than the patients with hemiarthroplasty and experienced less problems in several aspects of life. Walking ability was considered unchanged, compared to prefracture, to a larger extent in the secondary total hip arthroplasty group. Thus, secondary total hip arthroplasty in patients with healing complication following primary osteosynthesis gives better long-term functional capacity than that obtained with a primary hemiarthroplasty.

Combined survivorship and multivariate analyses of revisions in 799 hip prostheses. A 10- to 20-year review of mechanical loosening.

From 1970 to 1980 cemented metal-on-plastic total hip replacement was performed on 799 hips with primary osteoarthritis using one surgical technique. At the 10- to 20-year follow-up there had been 97 revisions for mechanical loosening. Univariate survivorship analysis showed that an increased risk of revision was associated with male gender, young age at primary THR, the Brunswik and Lubinus snap-fit prostheses with large femoral heads (as compared with the Charnley prosthesis), and varying experience of the surgeon. Multivariate statistical analysis showed a three-fold increased risk of revision for men (p < 0.0001), an increase in relative risk of 1.8 per 10 years younger at surgery (p < 0.0001), a fivefold increase in risk for the Brunswik prosthesis (p < 0.0001) and a twofold increase for the Lubinus prosthesis (p = 0.0067). Inexperience of the surgeon, however, was not validated as a risk factor. The study shows that the true risk factors for revision can be identified accurately by combining univariate survivorship and multivariate statistical analyses.

Early radiographic loosening impairs the function of a total hip replacement. The Nottingham Health Profile of 49 patients at five years.

We made a study of 49 total hip arthroplasties at five years, comparing the Charnley hip score, the Nottingham Health Profile (NHP) score and the appearance on serial radiographs. Each of the three investigations was performed by an independent observer with no knowledge of the results of the other two studies. The eight patients with radiographic signs of prosthetic loosening had significant reductions in function and quality of life as measured by the NHP questionnaire, but no differences in the mean Charnley hip scores. None of the eight patients had clinical signs of prosthetic loosening sufficient to recommend revision of their THR. The NHP is a relatively low-cost method of providing long-term follow-up of THR.

Factors predicting healing complications in femoral neck fractures. 138 patients followed for 2 years.

We have previously studied the radiographic outcome of femoral neck fracture osteosynthesis with either two hook-pins or a four-flanged nail performed by a small group of surgeons with special interest in the methods. In 138 femoral neck fractures a backwards stepwise logistic regression analysis was used to study the significance of preoperative fracture-related factors, intraoperative factors and the osteosynthesis. The development of non-union/redisplacement and segmental collapse of the femoral head was influenced by fracture displacement (P 0.001) and method of osteosynthesis (P 0.007). The postoperative scintimetric ratio was influenced by the method of osteosynthesis (P 0.0003), fracture displacement (P 0.004) and by the presence of a posterior fragment (P 0.03). Reduction of the fracture and positioning of the osteosynthesis were to a large extent within the accepted limits. This may explain why the previously well documented negative effects of malpositioning of the osteosynthesis and inferior reduction were not demonstrated to influence the rate of healing-complications. We conclude that neither patient age, sex nor preoperative fracture variables, with the exception of the extent of fracture displacement, can be used to predict radiographic healing-complications in femoral neck fractures.

Femoral neck fracture fixation with hook-pins. 2-year results and learning curve in 626 prospective cases.

We performed a prospective 2-year follow-up study of 626 consecutive femoral neck fractures treated with closed reduction and hook-pin fixation in all cases. The woman:man ratio was 2.9:1, the displaced:undisplaced fracture ratio 2.6:1. Mean patient age was 78 (18-100) years. The first 476 fractures were operated on by one of six surgeons with special interest in the technique, while the remaining operations were performed by any of the 35 surgeons in the department, all specialists in orthopedic surgery. Mortality within two years was 31 percent. Healing complications (redisplacement, nonunion or segmental femoral head collapse) in the total material/survivors only were for undisplaced fractures 5/7 percent, for displaced fractures 30/41 percent and for the total material 23/32 percent. According to life-table analysis, the complication rate in the total material at two years was 24 percent. The rate of secondary arthroplasty for healing complications was 13/19 percent. For displaced fractures, as well as for the total material, the group of specially interested surgeons had better results than the department as a whole.

Perceived health in hip-fracture patients: a prospective follow-up of 100 patients.

We report the impact of the treatment and rehabilitation in hip-fracture patients by using self-assessment instruments of perceived health and relate them to objective outcome assessments, such as ADL (personal hygiene/dressing), walking ability and technical complications. Subjective and objective status for 100 hip-fracture patients admitted from their own home, and rehabilitated in primary health care, were registered over 1 year after fracture. Mean age was 74, and 80% of the patients were women. Two self-assessment questionnaires: the Nottingham Health Profile (NHP part 1) and the Mood Adjective Checklist (MACL) were answered by the patients 6 and 12 months after fracture and compared with functional status (ADL, and walking ability) 4 months after fracture. Problems related to the hip fracture such as pain and physical mobility had most effect on the self-assessment questionnaire (NHP) and were in accordance with the district physiotherapists' evaluation of function. Patients with complications (resulting in nail extraction and total hip replacement) after the primary hip osteosynthesis and patients with a poor function 4 months after fracture had scores in the self-assessment questionnaires indicating a more pronounced and distressing impact of the disease. Small changes in subjective mood (MACL) were found. In an acute, curable, disease such as hip fracture the objective outcome seems as informative as the subjective evaluations of patients' self-assessment.

Function of the hip after femoral neck fractures treated by fixation or secondary total hip replacement.

Two matched groups of 28 patients each, with femoral neck fractures treated by primary internal fixation or by secondary total hip replacement after a complication of primary treatment, were evaluated and compared five years or more after primary pin fixation or secondary total hip replacement. The Nottingham Health Profile questionnaire was sent and returned by mail and the patient groups were matched with regard to age, sex, health, and social situation. Patients with healed fractures had less problems with sleep, housework and hobbies, and thus functioned better than patients who had required a secondary total hip replacement.

Secondary total hip replacement after fractures of the femoral neck.

We studied the rate of revision in 84 consecutive total hip replacements performed for failed osteosynthesis of femoral neck fractures and compared it with that for primary arthroplasty for osteoarthritis. The age and sex adjusted risk of prosthetic failure was 2.5 times higher after failure of fixation, but all the excess risk was in patients over 70 years of age. There were radiographic signs of loosening of the femoral component at five to 12 years after secondary arthroplasty in six of 33 survivors. In general, the results of secondary replacement were no worse than those obtained after primary arthroplasty for femoral neck fracture. We consider that internal fixation should be the primary procedure: total hip replacement is a safe secondary procedure when osteosynthesis fails.

CT scans and lipohaemarthrosis in hip fractures.

Computed tomography was performed on 40 patients with recent hip trauma. Radiographs of 25 showed a fracture of the femoral neck with slight displacement; 24 of these had intra-articular fluid and 20 had a lipohaemarthrosis on the CT scan. In 15 patients, radiographs at the time of admission were normal but suspicion of fracture remained. A fracture was later verified in five patients, four of whom had lipohaemarthrosis on admission. In the remaining 10 patients no fracture could be detected; only one patient had a hip joint effusion but no free fat. Thus all 24 patients with lipohaemarthrosis had an intracapsular fracture of the hip. We suggest CT for patients with hip trauma and negative radiographs. The presence of a lipohaemarthrosis of the hip strongly suggests an intra-articular fracture of either the femoral neck or the acetabulum.

Internal fixation of femoral neck fractures in Parkinson's disease. 32 patients followed for 2 years.

32 patients, suffering from Parkinson's disease, had internal fixation of femoral neck fractures. In 24 displaced fractures, 6 nonunions and 3 segmental collapses were seen; and in 8 undisplaced fractures, 1 case of segmental collapse was diagnosed. Healing complications were thus seen in one third. Total hip replacement for healing complication was performed in 3 of 32 patients. 9 patients died within 2 years. No difference in the rate of healing or mortality was detected compared with hip fracture patients without Parkinson's disease. Our study does not support primary arthroplasty for femoral neck fracture in patients with Parkinson's disease.

Secondary arthroplasty for complications of femoral neck fracture.

We report a series of 640 consecutive cervical hip fractures which were followed prospectively for two years after primary internal fixation with two hook-pins. Secondary arthroplasties were performed as salvage procedures in 75 cases and the early outcome of these was studied retrospectively. The mean time in hospital was 25 days for prosthetic replacement, though 60% of the patients had other medical conditions considered as risk factors. Mortality was 5% after six months and 8% after one year. Dislocation was seen in 11% and additional surgery was required in 4%. There was one case of deep infection and one supracondylar femoral fracture. In some cases there was considerable delay between the primary and secondary operation due to lack of awareness of functional deterioration, but although many patients had poor mobility before the secondary operation this was greatly improved within six weeks of the arthroplasty. We conclude that elective secondary hip arthroplasty for failure of fracture fixation is a safe and successful procedure. Once the decision to perform an arthroplasty is taken, this should be done without delay to avoid deterioration of function.

Function after hook-pin fixation of femoral neck fractures. Prospective 2-year follow-up of 191 cases.

Totally, 191 consecutive patients with femoral neck fractures during 1984 and 1985 had internal fixation with hook-pins and were prospectively investigated. Within 2 years, 62 patients had died and 47 had developed healing complications, 30 of whom had been treated with total hip replacement. Thus, 82 healed without complication. Forty-one of 47 patients without other handicaps affecting their walking ability considered their gait as good as it was preoperatively; 45 used no walking aids or a cane. Nine of 35 patients with a nonfracture-related disease affecting their walking ability managed to walk with or without a cane; 13 considered their walking ability unaltered compared with their prefracture state. Three of 82 patients complained of pain on walking and 2 of pain at rest. All but 1 could flex their hip 90 degrees or more. We believe that the function after internal fixation of cervical hip fracture with uncomplicated healing is superior to that achieved by primary hip replacement; primary replacement is recommended only in rheumatoid patients with displaced fractures.

Hemarthrosis after femoral neck fracture fixation.

In 34 femoral neck fractures, CT was performed within 1-32 days after internal fixation. All the cases except one showed an increased distance between the femoral neck and the anterior aspect of the joint capsule as compared with the intact side, indicating varying degrees of hip joint effusion and/or synovitis. Hip joint aspiration in 11 patients revealed increased intracapsular pressure varying between 10 and 112 mmHg and volumes of aspirated joint effusion up to 23 ml. Pain relief and increased joint motion after drainage of the intracapsular effusion was observed in 3 patients whose postoperative mobilization was facilitated.

Nailing of femoral neck fracture. Clinical and sociologic 5-year follow-up of 510 consecutive hips.

In a retrospective population-based study, 510 consecutive cervical hip fractures treated by internal fixation with a spring-loaded four-flanged nail, early weight bearing, and social rehabilitation were examined at 5 years after primary nailing. Six (1.6 percent) deep infections occurred. After a new trauma, seven fractures through the nail entrance were seen. Mortality at 2 years was 32 percent and at 5 years 53 percent. With a program for active rehabilitation, 80 percent of the survivors coming from independent living returned to this and remained there. The frequency of reoperations in patients below age 70 years was twice as high as in those over 70. Secondary arthroplasty was performed in 6 percent of the 129 undisplaced fractures and in 25 percent of the 381 displaced fractures. Totally, 67 percent of the fractures had no secondary procedure, not even nail extraction.

Acetabular fracture causing hip joint tamponade. A case report.

An 81-year-old woman had severe hip pain after a fall. Radiography was normal, but computed tomography and sonography showed a minor, displaced acetabular fracture and hemarthrosis. Aspiration of 15 ml of blood reduced the intracapsular pressure in the neutral position from 30 kPa to atmospheric pressure with relief of pain and increased joint motion. This case confirms that acetabular fracture may escape radiographic diagnosis and cause hip joint tamponade. Aspiration should be considered as a palliative and possibly therapeutic measure.

Intracapsular pressures in undisplaced fractures of the femoral neck.

We studied intracapsular pressure in 50 patients with Garden Grade I and II subcapital fractures. Before operation pressures varied from zero to 320 mmHg, 16 patients having an intracapsular pressure of over 80 mmHg. The pressure was increased considerably by medial rotation and decreased by lateral rotation and especially by semi-flexion. From zero to 36 ml of blood was aspirated; the amount did not correlate with the intracapsular pressure. Of 25 patients who were also examined by scintimetry, 13 had reduced uptake at the femoral head before aspiration, and nine of these showed a marked increase in uptake after aspiration. Intracapsular tamponade of the hip may be one reason for the occasional occurrence of segmental collapse of the femoral head after subcapital fracture with minor displacement.