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The use of recombinant human bone morphogenetic protein 2 (rhBMP-2) to promote spinal fusion in a nonhuman primate anterior interbody fusion model.

STUDY DESIGN: A study on the efficacy of recombinant human bone morphogenetic protein 2 (rhBMP-2) in a nonhuman primate anterior interbody fusion model. OBJECTIVES: To investigate the efficacy of rhBMP-2 with an absorbable collagen sponge carrier to promote spinal fusion in a nonhuman primate anterior interbody fusion model. SUMMARY OF BACKGROUND DATA: RhBMP-2 is an osteoinductive growth factor capable of inducing new bone formation in vivo. Although dosage studies using rhBMP-2 have been performed on species of lower phylogenetic level, they cannot be extrapolated to the primate. Dosage studies on nonhuman primates are essential before proceeding with human primate application. METHODS: Six female adult Macaca mulatta (rhesus macaque) monkeys underwent an anterior L7-S1 interbody lumbar fusion. All six sites were assigned randomly to one of two fusion methods: 1) autogenous bone graft within a single freeze-dried smooth cortical dowel allograft cylinder (control) or 2) rhBMP-2-soaked absorbable collagen sponges within a single freeze-dried smooth cortical dowel allograft cylinder also soaked in rhBMP-2. The animals underwent a baseline computed tomography scan followed by 3- and 6-month postoperation scans. Anteroposterior and lateral radiographs of the lumbosacral spine were performed monthly. After the monkeys were killed, the lumbar spine fusion sites were evaluated. Histologic evaluation of all fusion sites was performed. RESULTS: The three monkeys receiving rhBMP-2-soaked collagen sponges with a freeze-dried allograft demonstrated radiographic signs of fusion as early as 8 weeks. The control animals were slower to reveal new bone formation. The computed tomography scans revealed extensive fusion of the L7-S1 lumbar vertebrae in the group with rhBMP-2. A pseudarthrosis was present in two of the control animals. CONCLUSIONS: This study was able to document the efficacy of rhBMP-2 with an absorbable collagen sponge carrier and a cortical dowel allograft to promote anterior interbody fusion in a nonhuman primate model at a dose of 0.4 mg per implant site (1.5 mg/mL concentration). The late of new bone formation and fusion with the use of rhBMP-2 and cortical dowel allograft appears to be far superior to that of autogenous cancellous iliac crest graft with cortical dowel allograft.

Animals↗

Management of wound sepsis after spinal fusion surgery.

In wound sepsis after spinal surgery a first attempt to control infection without removal of the implants is justified, as implant removal after correction of scoliosis and kyphosis and in reduction of slipped vertebrae would often cause instability of the segments operated on. If the first revision is not successful, a second should not be delayed too long. Sometimes partial removal of the implants may be sufficient for infection control, thus maintaining a certain stability. We use local antibiotic treatment with Septopal chains, as suction irrigation sometimes is complicated by secondary bacterial contamination. By applying this treatment rationale we were able to control infection in 50 out of 53 patients with wound infection.

Adolescent↗

Spinal fusion in the athlete.

Although there are a few anecdotal descriptions of the athlete who has gone on to win fame and fortune following a successful spinal fusion, there has been little, if any, scientific data available to aid the surgeon in his treatment of these highly motivated patients. At present, there is no guide to patient selection or to the operative procedure of choice. There is no standard postoperative rehabilitation program, and to date, an outcome study is sadly lacking. Therefore, it is worthwhile to look into this subject in greater detail.

Attitude of Health Personnel↗

Adult idiopathic scoliosis treated by anterior and posterior spinal fusion.

Twenty-six adults, ranging in age from nineteen to fifty-eight years old, were treated for idiopathic scoliosis by two-stage anterior and posterior spinal fusion. The goals of the combined procedure were to increase correction of the curve and decrease the rate of pseudarthrosis. Preoperatively, the major curves measured an average of 83 degrees, and on the best side-bend they averaged 59 degrees, a 29 per cent degree of flexibility. At the time of discharge from the hospital the curves had improved to an average of 44 degrees, a correction of the preoperative curve of 39 degrees or 47 per cent. At an average length of follow-up of forty-nine months, the major curves measured an average of 50 degrees, a 41 per cent correction compared with the initial curves. Twenty-three of the major curves were better than when they were measured on the preoperative radiograph of the best side-bend, by an average of 15 degrees, but eight curves were either the same or worse. No patient had pseudarthrosis or permanent neurological injury. It is our conclusion that a two-stage anterior and posterior fusion is of value for the treatment of the adult who has a rigid curve that requires maximum correction to allow the head, shoulders, and torso to be centered over the pelvis. We do not recommend the use of instrumentation for the anterior fusion as this did not increase the correction of the curve in this series of patients.

Adult↗

The effect of spinal fusion on the long-term outcome of idiopathic scoliosis. A case-control study.

We have investigated the effect of multisegmental spinal fusion on the long-term functional and radiological outcome in patients with scoliosis. We compared these patients both with those whose spine had not been fused, and with a control group. We studied 68 patients with idiopathic scoliosis (34 operative and 34 non-operative) who had been followed up for a minimum of five years after treatment. They were matched for age (mean 44 years) and Cobb angle (mean 54 degrees) at follow-up. An age- and gender-matched control group of 34 subjects was also recruited. All participants completed a questionnaire to assess spinal function and to grade the severity of back pain using a numerical rating scale. Radiographs of the spine were taken in the patients with scoliosis and lumbar degenerative changes were recorded. The spinal function scores for the patients with scoliosis who had had a fusion were similar to those who had not. Both scoliosis groups, however, had lower scores than the control group (p < 0.001). The frequency and severity of back pain were lower for patients with scoliosis and fusion than for those without, but higher for both scoliosis groups compared with the control group. Radiographs showed similar degenerative changes in both scoliosis groups.

Adult↗

Spinal fusion augmented by luque-rod segmental instrumentation for neuromuscular scoliosis.

Seventy-four patients who had deformity of the spine secondary to a neuromuscular disorder were treated using posterior fusion with Luque-rod segmental instrumentation. The mean curve was 73 degrees preoperatively and 38 degrees postoperatively. The mean loss of correction was 4 degrees at an average duration of follow-up of forty-two months (range, 2.0 to 7.3 years). Complications included one death, three deep wound infections, two pressure sores, six sets of broken rods, and one instance of distal rotation and migration of the rod. There were no major perioperative neurological complications. Failure of instrumentation occurred more frequently with 3/16-inch (4.8-millimeter) diameter than with 1/4-inch (6.4-millimeter) diameter stainless-steel rods. There was a tendency for cephalad progression of deformity when the fusion ended cephalad at or below the fourth thoracic vertebra. We concluded that Luque-rod segmental instrumentation with posterior spinal fusion is an effective treatment for patients who have neuromuscular scoliosis.

Adolescent↗

Bone morphogenetic proteins and spinal fusion.

Bone morphogenetic proteins (BMPs) have increasingly become a focus of research in the laboratory, with animal models, and in human clinical trials for the treatment of spinal disorders. Basic science research has elucidated the putative mechanism of action of BMPs, and the efficacy of BMPs in inducing bone formation has been evaluated in multiple animal models of anterior and posterior spinal fusion. Not only has BMP been shown to improve the quality and amount of bone formation when used as a supplement to autograft, it has also been shown to promote superior fusion in the absence of autograft, even in high-risk fusion models involving the use of nicotine or nonsteroidal antiinflammatory agents. Both completed and ongoing clinical trials have demonstrated the efficacy of recombinant BMP, leading to the first BMP product being approved for clinical use earlier this year. Animal models and clinical trials have also been used to evaluate the safety of BMPs. Although few complications have been reported, BMPs can induce heterotopic bone formation, especially when placed adjacent to exposed neural elements. Potentially more serious, antibody formation has been seen in up to 38% of patients in some clinical trials. No clinical sequelae have been reported despite the development of antibodies against BMP, a naturally occurring human protein implicated in processes other than osteoinduction. The future directions of biological manipulation of the osteoinduction process include further understanding of the interactions of the BMP subtypes, the interactions of BMP with its receptors, and exploring other molecules capable of osteoinduction.

Animals↗

Spinal fusion in situ in osteogenesis imperfecta.

Osteogenesis imperfecta in its most severe forms has a devastating effect on the peripheral and central skeleton, and patients are unable to walk. Spinal deformity is common and causes difficulty in sitting, pain and potentially life-threatening complications. Instrumented spinal fusion might be considered the treatment of choice, but the bone may be too weak to sustain the implants and autogenous bone graft is poor in quantity and quality. We present the preliminary results of a technique of fusion without instrumentation and using Keil bone graft in 5 patients with severe osteogenesis imperfecta. The curve was stabilised and back pain relieved.

Adult↗

A dual epidural catheter technique to provide analgesia following posterior spinal fusion for scoliosis in children and adolescents.

BACKGROUND: The authors report their experience with the use of a dual epidural catheter technique in controlling pain following long posterior spinal fusion and instrumentation for scoliosis in children and adolescents. METHODS: Following completion of the surgical procedure and prior to wound closure, the upper catheter was inserted with the tip directed cephalad to T1-4 while the tip of the lower catheter was positioned at the L1-4 level. As the surgical wound was being closed, the catheters were dosed with fentanyl and hydromorphone followed by a continuous infusion of ropivacaine plus hydromorphone. Postoperative pain was assessed every 2-4 h using a visual analogue score or an observational behavioural score (0=no pain, 10=worst imaginable pain). There were 14 patients ranging in age from 5-17 years (12.7 +/- 3.5) and in weight from 19-68 kg (44.3 +/- 17.5). The epidural catheters were left in place until the fifth postoperative day. RESULTS: The mean of the median pain score from each patient was 1.5 +/- 1.6, 1.6 +/- 1.5, 1.4 +/- 1.3, 1.1 +/- 1.1 and 0.9 +/- 0.9, respectively, on postoperative days 1 through 5. The mean of the maximum pain scores was 3.5 +/- 2.3 (range 0-7), 4 +/- 1.6 (range 2-6), 3.1 +/- 1.7 (range 1-6), 2.4 +/- 1.5 (range 0-4) and 2.2 +/- 1.4 (range 0-4), respectively, on postoperative days 1 through 5. CONCLUSION: No adverse effects related to epidural analgesia were noted.

Adolescent↗

Prospective radiographic and clinical outcomes and complications of single solid rod instrumented anterior spinal fusion in adolescent idiopathic scoliosis.

STUDY DESIGN: Prospective clinical cases series. OBJECTIVES: To prospectively evaluate outcomes and critically review radiographic results and complications associated with single solid rod anterior spinal fusions in adolescent idiopathic scoliosis with 2-year minimum follow-up (range, 2-6 years). METHODS: Ninety consecutive patients at a single institution with thoracic (n = 43) or thoracolumbar/lumbar (n = 47) adolescent idiopathic scoliosis were treated by one of two surgeons with a similar anterior surgical technique using rib autograft, intradiscal structural (Harms) cages placed below T12, and anterior single solid rod convex compressive instrumentation. The patients were evaluated prospectively with the Scoliosis Research Society outcome instrument and upright radiographs before surgery and minimum 2-year follow-up. RESULTS (RADIOGRAPHIC): The average coronal correction of thoracic curves was from 55 degrees to 29 degrees (47%). The average correction of thoracolumbar/lumbar curves was from 50 degrees to 15 degrees (70%). In the sagittal plane, kyphosis was improved in thoracic fusions from 23 degrees to 30 degrees (T5-T12) and lordosis maintained in thoracolumbar/lumbar fusions at -58 degrees (T12-sacrum). Five patients (5.5%) developed a pseudarthrosis, four with implant failure. Three of five required a posterior fusion for a reoperation rate of 3.3%. The fourth and fifth patients were asymptomatic and appeared fused at the 2-year follow-up, with minimal loss of correction. Common risk factors for pseudarthrosis were smoking (4 of 5), weight >70 kg (4 of 5), and for thoracic pseudarthrosis, hyperkyphosis >40 degrees T5-T12 (2 of 3). RESULTS (CLINICAL OUTCOME): Scoliosis Research Society domain average scores were improved for function, pain, and self-image (P < 0.01). With the Scoliosis Research Society satisfaction domain, 88% responded that they were satisfied with their results and 89% would undergo the same treatment again. Four of five patients with pseudarthrosis did not have statistically significant lower final Scoliosis Research Society scores than those with solid fusions (93 vs. 97, P = 0.18). CONCLUSION: Anterior instrumented fusions for adolescent idiopathic scoliosis using a single solid rod had good radiographic and clinical outcomes. Consideration should be given to alternate techniques in larger adolescents (>70 kg) with thoracic hyperkyphosis (>40 degrees ), and smoking should be avoided. Poor radiographic outcomes did not correlate with final Scoliosis Research Society scores.

Adolescent↗

Spinal fusion surgery in children with non-idiopathic scoliosis: is there a need for routine postoperative ventilation?

BACKGROUND: The perioperative management of children with non-idiopathic scoliosis undergoing spinal deformity surgery has not been standardized and the current practice is to routinely ventilate these patients in the postoperative period. This study reports the experience from a single institution and evaluates the need and reasons for postoperative ventilation. Details of ventilated patients are presented. METHODS: All patients undergoing spinal fusion surgery for non-idiopathic scoliosis were recorded prospectively (2003-4). Patients were anaesthetized according to a standardized technique. Physical characteristics, cardiopulmonary function, intraoperative blood loss and fluid requirement, postoperative need for ventilation and all perioperative adverse events were recorded on a computer database. RESULTS: A total of 76.2% of patients were safely extubated at the end of surgery without any further complications or need for re-ventilation; 23.8% of patients required postoperative ventilation with half of the cases being planned before operation and 40% of all patients with Duchenne muscular dystrophy (DMD) required postoperative ventilation. There were no specific factors that could predict the need for postoperative ventilation, although an increased tendency for children with DMD and those with a preoperative forced vital capacity <30% towards requiring postoperative ventilation was observed. CONCLUSIONS: Early extubation can be safely performed after spinal deformity surgery for non-idiopathic scoliosis. The use of short-acting anaesthetics, drugs to reduce blood loss, experienced spinal anaesthetists and the availability of intensive care support are all essential for a good outcome in patients with neuromuscular disease and cardiopulmonary co-morbidity.

Adolescent↗

Posterolateral spinal fusion at unintended levels due to bone-graft migration: no effect on clinical outcome in 19/130 patients.

In a prospective randomized study, we evaluated the risk of lumbar posterolateral spinal fusion at an unintended level due to bone graft migration. 130 patients underwent fusion supplemented by pedicle screw fixation (Cotrell-Dubousset, 64 patients) or uninstrumented fusion (66 patients). This was assessed by two independent observers on antero-posterior, and lateral radiographs taken 1 year after surgery. All patients had ben operated on at the preoperatively planned levels. Both observers agreed that fusion had taken place at an unintended level in 19 cases (14%). We found a tendency towards a higher risk of this "complication" when using supplementary pedicle screw fixation. The functional outcome, assessed by the Dallas Pain Questionnaire and the Low Back Pain Rating scale, was similar in patients having fusion at an unintended level and in patients fused only at the intended levels. There was no difference between the two groups concerning reoperation rates, postoperative smoking or social status. We conclude that unintended fusion occurs and tends to be commoner with the use of pedicle screw instrumentation. However, this complication seems not to affect the functional outcome if fusion has taken place at the intended level.

Activities of Daily Living↗

Factors predicting postoperative complications following spinal fusions in children with cerebral palsy.

A retrospective review of 107 patients with cerebral palsy who had undergone a posterior spinal fusion with unit rod instrumentation by the same two surgeons was done to determine what factors cause complications that lead to delayed recovery time and a longer than average hospital stay. The operative risk score was developed with scores for the child's ability to walk and talk, oral feeding ability, cognitive ability, and medical problems within the year prior to surgery. Operative risk score is primarily a measure of degree of neurologic involvement. The postoperative complication score (POCS) is a combined measure of all postoperative complications including factors for prolonged intubation, intensive care unit stay, hospital stay, and delayed feeding. The mean age at surgery was 14.3 years. The mean weight was 29.5 kg, with 89 of 107 patients below the fifth percentile for weight compared with age. The mean degree of spinal deformity was 75.2 degrees (range 43-120 degrees ). The mean weight for age was -1.96 SD below the normal. The mean operative time was 4.3 h, with estimated blood loss of 1.2 blood volumes. The mean length of hospitalization was 23 days 2 h, with 5 days 2 h in the intensive care unit. The operative risk score and weight for chronological age below the fifth percentile showed statistical significance (p = 0.05) in regard to increased POCS. The weight for height-age and deficient total lymphocyte count, both factors that measure nutritional status, showed no statistical significance (p > 0.05) compared with POCS. Curves with deformity of >70 degrees had statistically significant high POCS (p = 0.03). Complications for patients having a posterior and an anterior surgery versus those who had a posterior fusion alone were not statistically different (p > 0.05). The factors that led to a greater rate of complications were the severity of neurologic involvement, severity of recent history of significant medical problems, and severity of scoliosis.

Adolescent↗

[The effect of pedicle screw instrumentation on posterolateral spinal fusion. A prospective, randomized study with a two-year follow-up].

The aim was to evaluate the effect of supplementary pedicle screw fixation (Cotrel-Dubousset [CD]) in posterolateral lumbar spinal fusion. The study comprises 130 patients undergoing lumbar or lumbosacral fusion for spondyloisthesis grades I-II or degenerative segmental instability conditions. The patients were randomly allocated for no instrumentation (n = 66) or CD instrumentation (n = 64) in posterolateral lumbar fusion. A 97.7% follow-up was achieved. There were no significant differences between the two groups concerning fusion rates assessed by X-ray or functional outcomes assessed by Dallas Pain Questionnaire. The global patient satisfaction was 82% in the instrumented group versus 74% in the noninstrumented group. Instrumentation increased both operation time, blood loss, and early re-operation rates significantly. A high patient satisfaction was found in both groups. However, the results from this study do not justify the general use of pedicle screw fixation alone as an adjunct to posterolateral lumbar fusion.

Adult↗

Deep vein thrombosis in lumbar spinal fusion: a prospective study of antiembolic and pneumatic compression stockings.

We prospectively studied the incidence of deep vein thrombosis (DVT) of the thigh in 117 patients having posterior lumbar spinal fusion with instrumentation and bone grafting for degenerative disk disease or spondylolisthesis. Patients with neoplasm, infection, trauma, or history of DVT were excluded. Patients were randomized into two groups. In the operating room, group 1 patients were placed in thigh-high antiembolic compression stockings (TED hose), and group 2 patients were placed in antiembolic stockings and pneumatic compression stockings. In both groups, the stockings were used until discharge. Postoperatively, patients in both groups received 600 mg buffered aspirin twice daily. Comparative analysis of the two groups showed no difference in operative time, blood loss, number of levels of lumbar vertebrae fused, time to mobilization, weight, age, or sex. All patients had duplex scanning of the thigh postoperatively. No patient in the series was observed to have acute DVT by clinical examination or by ultrasonography.

Adult↗

Induced moderate hypotensive anesthesia for spinal fusion and Harrington-rod instrumentation.

The effect of moderate hypotensive anesthesia on blood loss, need for transfusion, and length of surgery of forty-nine patients who underwent posterior spinal fusion and Harrington-rod instrumentation was compared retrospectively. Twenty-seven patients were given enflurane as the main anesthetic agent, with fentanyl supplementation, and their blood pressure was maintained at twenty to thirty millimeters of mercury less than the preoperative systolic blood pressure. These patients were compared with twenty-two patients who had been anesthetized with nitrous oxide, oxygen, and narcotic technique and were normotensive throughout the duration of the anesthesia. The results were analyzed by the unpaired Student t test. Moderate hypotensive anesthesia was found to significantly decrease the average blood loss by nearly 40 per cent, reduce the need for transfusion by nearly 45 per cent, and shorten the average operating time by nearly 10 per cent. No complications attributable to the anesthetic technique occurred. The findings of this study suggest that moderate hypotensive anesthesia with enflurane and fentanyl supplementation may be of benefit in scoliosis surgery by reducing blood loss, the need for blood replacement, and operating time.

Adolescent↗

Dose-response of ketorolac as an adjunct to patient-controlled analgesia morphine in patients after spinal fusion surgery.

UNLABELLED: This randomized, blind study was designed to determine the appropriate dose of ketorolac (a drug used as a supplement to opioids) to administer to patients who have undergone spinal stabilization surgery. The ketorolac was administered every 6 h, in addition to patient-controlled analgesia (PCA) with morphine, to 70 inpatients undergoing spine stabilization by one surgeon. The study was performed to determine the analgesic efficacy and incidence of side effects with different doses of ketorolac. The patients were divided into seven groups. They were given either i.v. saline (control group) or i.v. ketorolac (5, 7.5, 10, 12.5, 15, or 30 mg) every 6 h. The outcomes measured included pain scores, 24-h morphine usage, level of sedation, and side effect profile six times during the first 24 h postoperatively. The total dose of morphine was significantly larger in the control and 5 mg ketorolac groups than in the other five groups. Morphine consumption was similar in all groups receiving > or = 7.5 mg of ketorolac. The pain scores were significantly higher in the control group than in some of the larger dose groups at three of the study intervals. The 5 mg group had higher pain scores than the other groups at most of the time intervals studied. There were no significant differences in pain scores among the other five groups. Sedation scores were higher (i.e., patients were more sedated) in the control group than in the other six groups at three of the time periods. We conclude that the administration of ketorolac 7.5 mg every 6 h has a morphine-sparing effect equivalent to that of larger doses in patients undergoing spine stabilization surgery. Using larger doses of ketorolac did not result in less somnolence, lower morphine use, or less pain. We recommend that ketorolac 7.5 mg be given every 6 h to patients undergoing spinal fusion surgery in addition to PCA morphine. IMPLICATIONS: Using smaller doses of ketorolac (e.g., 7.5 mg every 6 h) as a supplement to morphine patient-controlled analgesia is as effective as larger doses in patients who have undergone spine stabilization surgery.

Adult↗