Two-piece ALIF cage optimizes the bone-implant interface in a 360° setting.

INTRODUCTION: Clinical research has documented that cage subsidence and the loss of balance correction is a significant complication related to spinal fusion. Subsidence is a multifactorial complication, where implant design is one important element. The aim of the study is to compare the rigidity and bone-implant relative motion of segments treated with either a conventional one-piece ALIF cage versus a two-piece ALIF cage, which adapts in situ and permits 7°-21° of lordosis. METHODS: Seven lumbosacral (L3-S1) human cadaver specimens were tested in a universal spine tester in the intact condition, the specimens instrumented with a two-piece ALIF cage (Statur®-L, FBC Device, Denmark) and a one-piece ALIF cage (Pezo™-A, Ulrich GmbH & Co. KG., Germany), both supplemented with a pedicle screw system using pure moments of ±7.5 Nm in three principal motion directions. For assessment of the bone-implant interface, fluoroscopic videos were captured during motion and 3D motion was measured using an optical motion capturing system. RESULTS: Significantly less motion at the implant-endplate interface was found for the two-piece cage (1.0° ± 0.6°) in comparison to the one-piece cage (4.2° ± 1.7°) in flexion/extension. No significant differences in segment rigidity were found between the one-piece and two-piece cages in the 360° setup, while both configurations significantly reduced the range of motion compared to the intact condition (p < 0.05). CONCLUSION: In comparison to the traditional one-piece ALIF cages, the two-piece cage concept reduced the relative motion at the bone-implant interface without compromising stability.

Physical activity level, leisure activities and related quality of life 1 year after lumbar decompression or total hip arthroplasty.

PURPOSE: Lumbar decompression surgery (LDS) and total hip arthroplasty (THA) are frequently performed in the elderly population, but very little is known about their subsequent physical capacity and participation in leisure activities. Despite similar demographics and comorbidities, it is questionable whether LDS patients achieve equally high levels of physical capacity and quality of life postoperatively as do THA patients. The aim was to compare the physical activity level, participation in leisure activities and related quality of life 1 year after an LDS and THA procedure. METHODS: Data from 95 THA patients and 83 LDS patients were gathered from questionnaires on self-reported physical activity level, leisure activities and quality of life. RESULTS: LDS and THA patients reported equally moderate levels of physical activity. The median score was 42.3 METs/day (IQR 37.9; 47.7) for the LDS group and 41.0 METs/day (IQR 38.5; 48.5) for the THA group (p = 0.79). Weekly time consumption for leisure activities in the LDS group was a median of 420 min/week (IQR 210; 660) compared to a median of 480 min/week (IQR 240; 870) in the THA group (p = 0.16). Regarding quality of life, LDS patients reported significantly worse Euroqol Five Dimensions scores with a median value of 0.740 (IQR 0.68; 0.82) compared to THA patients' median of 0.824 (IQR 0.72; 1.0), p < 0.001. CONCLUSION: Despite being equally physically active and engaged in leisure activities, LDS patients did not achieve a quality of life comparable to that of THA patients 1 year postoperatively.

The effect of timing of rehabilitation on physical performance after lumbar spinal fusion: a randomized clinical study.

BACKGROUND: The number of patients undergoing lumbar spinal fusion procedures (LSF) has risen in recent years, but only few studies have examined different rehabilitation strategies for this patient group. PURPOSE: To evaluate the impact of initiating rehabilitation either 6 or 12 weeks after a LSF based on the patients' physical performance using the 6-min walking test (6MWT) and the Åstrand Fitness test (AF-test) as measurement. METHODS: A multicentre RCT including 82 patients with degenerative disc diseases undergoing LSF randomly assigned to initiate rehabilitation either 6 or 12 weeks after surgery. Both groups received the same group-based rehabilitation. The main outcome measures were the 6MWT and the AF-test, secondarily questionnaire-based measures. Follow-up at baseline as well as at 3, 6 and 12 months after surgery. RESULTS: Comparing the two groups no statistically significant difference was found in walking distance or fitness over time. In both groups, the patients achieved an overall increase in walking distance (p < 0.01), but no improvement in fitness. The 6MWT showed significant correlation (-0.37 to -0.59) with the questionnaire-based outcome measures (p < 0.01). The AF-test did not correlate to either the 6MWT or any of the questionnaire-based outcome measures. CONCLUSION: No difference was found in the effect of initiating rehabilitation either 6 or 12 weeks after LSF on the patients' physical performance in terms of fitness and walking distance. The 6MWT showed fair to moderate correlation to the questionnaire-based outcome measures. The AF-test showed no significant independent value, and we question its use in LSF patients.

Fusion mass bone quality after uninstrumented spinal fusion in older patients.

Older people are at increased risk of non-union after spinal fusion, but little is known about the factors determining the quality of the fusion mass in this patient group. The aim of this study was to investigate fusion mass bone quality after uninstrumented spinal fusion and to evaluate if it could be improved by additional direct current (DC) electrical stimulation. A multicenter RCT compared 40 and 100 µA DC stimulation with a control group of uninstrumented posterolateral fusion in patients older than 60 years. This report comprised 80 patients who underwent DEXA scanning at the 1 year follow-up. The study population consisted of 29 men with a mean age of 72 years (range 62-85) and 51 women with a mean age of 72 years (range 61-84). All patients underwent DEXA scanning of their fusion mass. Fusion rate was assessed at the 2 year follow-up using thin slice CT scanning. DC electrical stimulation did not improve fusion mass bone quality. Smokers had lower fusion mass BMD (0.447 g/cm(2)) compared to non-smokers (0.517 g/cm(2)) (P = 0.086). Women had lower fusion mass BMD (0.460 g/cm(2)) compared to men (0.552 g/cm(2)) (P = 0.057). Using linear regression, fusion mass bone quality, measured as BMD, was significantly influenced by gender, age of the patient, bone density of the remaining part of the lumbar spine, amount of bone graft applied and smoking. Fusion rates in this cohort was 34% in the control group and 33 and 43% in the 40 and 100 µA groups, respectively (not significant). Patients classified as fused after 2 years had significant higher fusion mass BMD at 1 year (0.592 vs. 0.466 g/cm(2), P = 0.0001). Fusion mass bone quality in older patients depends on several factors. Special attention should be given to women with manifest or borderline osteoporosis. Furthermore, bone graft materials with inductive potential might be considered for this patient population.

Alendronate treatment improves bone-pedicle screw interface fixation in posterior lateral spine fusion: an experimental study in a porcine model.

The bone-screw interface has been indicated as the weak link in pedicle screw spine fixation. Bisphosphonate treatment may have the effect of improving bone-screw interface fixation in spine fusion by inhibiting bone resorption. An experimental study was conducted using a porcine model to evaluate the influence of alendronate treatment on bone-pedicle screw interface fixation. Eleven pigs in the treatment group received alendronate 10 mg/day orally for three months postoperatively. The other 11 pigs served as a control group. Posterior lateral fusion with the CD Horizon pedicle screw system was performed with autograft on the lumbar spine on all animals. Biomechanical torsion test and histomorphometric parameters of screw fixation were evaluated three months after the operation. The maximum torque and initial angular stiffness of the treatment group was higher than that of the control group, but there was no statistical significance. The bone-screw contact surface was 23.3 +/- 10% for the treatment group and 9.8 +/- 5.9% for the control group (P < 0.01). This study indicated that alendronate treatment increased bone purchase of stainless steel screw surfaces.

Cost-effectiveness evaluation of an RCT in rehabilitation after lumbar spinal fusion: a low-cost, behavioural approach is cost-effective over individual exercise therapy.

Recently, Christensen et al. reported the clinical effects of a low-cost rehabilitation program equally efficient to a relatively intensive program of individual, physiotherapist-guided exercise therapy. Yet, the low-cost approach is not fully supported as an optimal strategy until a full-scale economic evaluation, including extra-hospital effects such as service utilization in the primary health care sector and return-to-work, is conducted. The objective of this study was to conduct such evaluation i.e. investigate the cost-effectiveness of (1) a low-cost rehabilitation regimen with a behavioural element and (2) a regimen of individual exercise therapy, both in comparison with usual practice, from a health economic, societal perspective. Study design was a cost-effectiveness evaluation of an RCT with a 2-year follow-up. Ninety patients having had posterolateral or circumferential fusion (indicated by chronic low back pain and localized pathology) were randomized 3 months after their spinal fusion. Validated pain- and disability index scales were applied at baseline and at 2 years postoperative. Costs were measured in a full-scale societal perspective. The probability of the behavioural approach being cost-effective was close to 1 given pain as the prioritized effect measure, and 0.8 to 0.6 (dependent on willingness to pay per effect unit) given disability as the prioritized effect measure. The probability of the exercise therapy approach being cost-effective was modest due to inferior effectiveness. Results proved robust to relevant sensitivity analysis although a differentiated cost-effectiveness ratio between males and females was suspected. In conclusion, a simple behavioural extension, of setting up group meetings for patients, to a regimen with a strict physiotherapeutic focus was found cost-effective, whereas the cost-effectiveness of increasing frequency and guidance of a traditional physiotherapeutic regimen was unlikely in present trial setting.

The positive effect of posterolateral lumbar spinal fusion is preserved at long-term follow-up: a RCT with 11-13 year follow-up.

INTRODUCTION: Few studies have investigated the long-term effect of posterolateral lumbar spinal fusion on functional outcome. AIM: To investigate the long-term result after posterolateral lumbar spinal fusion with and without pedicle screw instrumentation. METHODS: Questionnaire survey of 129 patients originally randomised to posterolateral lumbar spinal fusion with or without pedicle screw instrumentation. Follow-up included Dallas Pain Questionnaire (DPQ), Oswestry Disability Index (ODI), SF-36 and a question regarding willingness to undergo the procedure again knowing the result as global outcome parameter. RESULTS: Follow-up was 83% of the original study population (107 patients). Average follow-up time was 12 years (range 11-13 years). DPQ-scores were significantly lower than preoperatively in both groups (P < 0.005) and no drift towards the preoperative level was seen. No difference between the two groups were observed (instrumented vs. non-instrumented): DPQ Daily Activity mean 37.0 versus 32.0, ODI mean 33.4 versus 30.6, SF-36 PCS mean 38.8 versus 39.8, SF-36 MCS mean 49.0 versus 53.3. About 71% in both groups were answered positively to the global outcome question. Patients who had retired due to low back pain had poorer outcome than patients retired for other reasons, best outcome was seen in patients still at work (P = 0.01 or less in all questionnaires, except SF-36 MCS P = 0.08). DISCUSSION: Improvement in functional outcome is preserved for 10 or more years after posterolateral lumbar spinal fusion. No difference between instrumented fusion and non-instrumented fusion was observed. Patients who have to retired due to low back pain have the smallest improvement.

Early versus late initiation of rehabilitation after lumbar spinal fusion: economic evaluation alongside a randomized controlled trial.

STUDY DESIGN: Economic evaluation conducted alongside a randomized controlled trial with 1-year follow-up. OBJECTIVE: To examine the cost-effectiveness of initiating rehabilitation 6 weeks after surgery as opposed to 12 weeks after surgery. SUMMARY OF BACKGROUND DATA: In a previously reported randomized controlled trial, we assessed the impact of timing of rehabilitation after a lumbar spinal fusion and found that a fast-track strategy led to poorer functional ability. Before making recommendations, it seems relevant to address the societal perspective including return to work, quality of life, and costs. METHODS: A cost-effectiveness analysis and a cost-utility analysis were conducted. Eighty-two patients undergoing instrumented lumbar spinal fusion due to degenerative disc disease or spondylolisthesis (grade I or II) were randomized to an identical protocol of 4 sessions of group-based rehabilitation and were instructed in home exercises focusing on active stability training. Outcome parameters included functional disability (Oswestry Disability Index) and quality-adjusted life years. Health care and productivity costs were estimated from national registries and reported in euros. Costs and effects were transformed into net benefit. Bootstrapping was used to estimate 95% confidence intervals (95% CI). RESULTS: The fast-track strategy tended to be costlier by €6869 (95% CI, -4640 to 18,378) while at the same time leading to significantly poorer outcomes of functional disability by -9 points (95% CI, -18 to -3) and a tendency for a reduced gain in quality-adjusted life years by -0.04 (95% CI, -0.13 to 0.01). The overall probability for the fast-track strategy being cost-effective does not reach 10% at conventional thresholds for cost-effectiveness. CONCLUSION: Initiating rehabilitation at 6 weeks as opposed to 12 weeks after surgery is on average more costly and less effective. The uncertainty of this result did not seem to be sensitive to methodological issues, and clinical managements who have already adapted fast-track rehabilitation strategies have reason to reconsider their choice. .

Degenerative spondylolisthesis is associated with low spinal bone density: a comparative study between spinal stenosis and degenerative spondylolisthesis.

Spinal stenosis and degenerative spondylolisthesis share many symptoms and the same treatment, but their causes remain unclear. Bone mineral density has been suggested to play a role. The aim of this study was to investigate differences in spinal bone density between spinal stenosis and degenerative spondylolisthesis patients. 81 patients older than 60 years, who underwent DXA-scanning of their lumbar spine one year after a lumbar spinal fusion procedure, were included. Radiographs were assessed for disc height, vertebral wedging, and osteophytosis. Pain was assessed using the Low Back Pain Rating Scale pain index. T-score of the lumbar spine was significantly lower among degenerative spondylolisthesis patients compared with spinal stenosis patients (-1.52 versus -0.52, P = 0.04). Thirty-nine percent of degenerative spondylolisthesis patients were classified as osteoporotic and further 30% osteopenic compared to only 9% of spinal stenosis patients being osteoporotic and 30% osteopenic (P = 0.01). Pain levels tended to increase with poorer bone status (P = 0.06). Patients treated surgically for symptomatic degenerative spondylolisthesis have much lower bone mass than patients of similar age treated surgically for spinal stenosis. Low BMD might play a role in the development of the degenerative spondylolisthesis, further studies are needed to clarify this.

Early, intensified home-based exercise after total hip replacement--a pilot study.

BACKGROUND AND PURPOSE: Despite a successful surgical procedure, deficits in muscle strength and physical function are documented 1-2 years after total hip replacement (THR). There is a lack of evidence concerning which rehabilitation strategy is the most effective after THR. The purpose of this pilot study was to investigate the feasibility of an early-initiated intensified, home-based training regime and to form the basis of future studies with regard to exercises, outcome measures and power calculations. METHODS: The trial is a single-blinded, cluster-randomized controlled trial performed at an orthopaedic physiotherapy department in a public hospital in Denmark. A consecutive sample of 46 patients undergoing primary THR surgery for osteoarthritis between September 2008 and January 2009 was included. Forty-four patients completed the trial (96% follow-up). Participants were randomly assigned to an intervention group (IG, n = 23) receiving 12 weeks of intensified exercises (e.g. rubber band resistance) or a control group (CG, n = 21) receiving standard rehabilitation exercises without external resistance. The outcome measurements were maximal gait speed, isometric hip abductor muscle strength, one-legged stance, health-related quality of life (EuroQol-5 Dimensions), patient satisfaction, and patient-evaluated function, stiffness and pain (Western and Ontario McMasters University Osteoarthritis Index). RESULTS: There were significant increases in both groups in all the measurements during the 12 weeks of exercises. All participants in the IG were satisfied or very satisfied with the exercises compared with 85% in the CG (P = 0.095). In the IG, four participants (17.4%) had difficulties when performing the intensified exercises at home. Hip abduction strength was significantly weaker in the leg operated compared with the leg not operated on after the intervention in both groups (P < 0.01). CONCLUSION: This pilot study indicates that the majority of THR patients tolerated early-initiated intensified exercises without additional pain and with high patient satisfaction. It seems that some of the patients need supervision to perform intensified exercises.

The effect of early initiation of rehabilitation after lumbar spinal fusion: a randomized clinical study.

STUDY DESIGN: A multicenter randomized clinical trial including 82 patients. OBJECTIVE: To examine the effect of early initiation of rehabilitation after instrumented lumbar spinal fusion. SUMMARY OF BACKGROUND DATA: Lumbar spinal fusion has been performed for more than 70 years. Yet, few studies have examined patients' subsequent rehabilitation. Group-based rehabilitation is both efficient and cost-effective in rehabilitation of lumbar spinal fusion patients. METHODS: Patients with degenerative disc diseases undergoing instrumented lumbar spinal fusion were randomly assigned to initiate their rehabilitation 6 weeks (6-wk group) or 12 weeks after lumbar spinal fusion (12-wk group). Both groups received the same group-based rehabilitation. Primary outcome was the Oswestry Disability Index. Secondary outcome was the Dallas Pain Questionnaire, the Low Back Pain Rating Scale, and absence from work. Wilcoxon rank-sum test was used to compare the groups in terms of differences from baseline to 6 months and 1-year follow-up. Results are presented in median with 25th and 75th percentiles. RESULTS: According to the Oswestry Disability Index, at 1-year follow-up, the 6-week-group had a median reduction of -6 (-19; 4) compared with -20 (-30;-7) in the 12-week group (P, 0.05). The Dallas Pain Questionnaire showed overall the same tendency, and within daily activities were significantly reduced in favor of the 12-week group (P, 0.05). For back pain, the 6-week group had a median reduction of -2.2 (-3.0; -0.7) similar with -3.3 (-4.7; -1.7) in the 12-week group (P, 0.05). The results at 6 months of follow-up were similar. No difference was found according to return to work 1 year postsurgery. CONCLUSION: Early start of rehabilitation (6 wk vs. 12 wk) after lumbar spinal fusion resulted in inferior outcomes. The improvements in the 12-week group were 4 times better than that in the 6-week group, indicating that the start-up time of rehabilitation is an important contributing factor for the overall outcome.

Dynamic midfoot kinematics in subjects with medial tibial stress syndrome.

BACKGROUND: Medial tibial stress syndrome (MTSS) is a common diagnosis. Several studies have demonstrated that excessive static navicular drop (ND) is related to the diagnosis. However, no studies have yet investigated ND and the velocity of ND during dynamic conditions. The aim of this study was to evaluate ND characteristics in patients with MTSS in dynamic and static conditions. METHODS: In a case-control study, 14 patients diagnosed as having MTSS were included from an orthopedic outpatient clinic. A control group consisting of 14 healthy participants was matched regarding age, sex, and typical sporting activity. Navicular drop was evaluated during treadmill walking by a two-dimensional video analysis. Static foot posture, static ND, dynamic ND (dND), and velocity of dND were compared. RESULTS: The two groups were comparable in relation to age, sex, height, weight, and foot size. No significant difference was found in static foot posture. Static ND showed a mean difference of 1.7 mm between the groups (P = .08). During treadmill walking, patients with MTSS had, on average, a 1.5-mm-larger dND (P =.004) and a 2.4-mm/sec-larger mean velocity of dND (P = .03). CONCLUSIONS: Patients with MTSS display a larger ND and a higher ND velocity during treadmill walking. Increased ND velocity may be important to this condition. Future studies should include velocity of dND to investigate the mechanisms of dND in relation to overuse injuries.

Sagittal spinal balance after lumbar spinal fusion: the impact of anterior column support results from a randomized clinical trial with an eight- to thirteen-year radiographic follow-up.

STUDY DESIGN: Randomized clinical trial. OBJECTIVE: To analyze the long-term clinical impact of anterior column support on sagittal balance after lumbar spinal fusion. SUMMARY OF BACKGROUND DATA: Several investigators have stressed the importance of maintaining sagittal balance in relation to spinal fusion to avoid lumbar 'flat back,' accelerated adjacent segment degeneration, pain, and inferior functional outcome. Only limited evidence exists on how sagittal alignment affects clinical outcome. Anterior lumbar interbody fusion combined with posterolateral fusion has been proved superior to posterolateral fusion alone regarding outcome and cost-effectiveness. No randomized controlled trial has been published analyzing the effect of anterior support on radiographic measurements of sagittal balance. METHODS: Between 1996 and 1999, 148 patients with severe chronic low back pain were randomly selected for posterolateral lumbar fusion plus anterior support (PLF + ALIF) or posterolateral lumbar fusion. A total of 92 patients participated. Sagittal balance parameters were examined on full lateral radiographs of the spine: pelvic incidence (PI), pelvic tilt (PT), sacral slope, thoracic kyphosis, lumbar lordosis, and positioning of C7 plumb line. The type of lumbar lordosis was evaluated and outcome assessed by Oswestry Disability Index (ODI). RESULTS: Follow-up rate was 74%. Sagittal balance parameters were similar between randomization groups. None of the parameters differed significantly between patients with an ODI from 0 to 40 and patients with ODI over 40. Balanced patients had a significantly superior outcome as measured by ODI (P < 0.05) compared with unbalanced patients. CONCLUSION: No difference in the investigated sagittal balance parameters was seen between patients treated with PLF + ALIF or posterolateral fusion alone. Lumbar lordosis and type of lordosis correlated with outcome but could not explain the superior outcome in the group with anterior support. Whether sagittal balance and anterior support during fusion provide a protective effect on adjacent motion segments remains unclear.

The predictive value of pain drawings in lumbar spinal fusion surgery.

BACKGROUND CONTEXT: Pain drawings have been used extensively in spine surgery. It has been associated with inferior outcome after disc and stenosis surgery. Results regarding the predictive value in fusion surgery have been conflicting. PURPOSE: To evaluate the predictive value of pain drawings in relation to outcome after lumbar spinal fusion. To investigate if there are differences between spondylolisthesis patients and patients with degenerative disease as well as between patients with or without radicular pain. STUDY DESIGN: Prospective clinical cohort with a minimum of 1-year follow-up. PATIENT SAMPLE: One hundred thirty-five patients undergoing lumbar spinal fusion. Fifty-seven men and 78 women, mean age 44 years (range 21-59 years). OUTCOME MEASURES: Dallas Pain Questionnaire (DPQ), Low Back Pain Rating Scale (LBPRS) pain index and patient satisfaction. Minimal clinical important difference was defined for the LBPRS score. METHODS: Pain drawings were classified, using the visual inspection method, as organic or nonorganic and correlated to outcomes. Multivariate adjustment for several possible confounding variables was done using logistic regression analysis. RESULTS: Thirty-three percent of the drawings were classified as nonorganic. Nonorganic drawings were associated with significantly higher DPQ and LBPRS scores preoperatively and at follow-up. Differences between organic and nonorganic drawings were larger in spondylolisthesis patients than in patients with degenerative disorders. Nonorganic pain drawings were associated with poorer outcome in patients with low back pain and radicular symptoms, however, not in patients without radicular symptoms. A nonorganic pain drawing predicted negative patient satisfaction with odds ratio (OR) 3.01 (95% confidence interval (CI): 1.14-8.55, p=.027) but had no significant predictive value with respect to improvement in the LBPRS pain index OR 1.92 (95% CI: 0.82-4.47, p=.132). CONCLUSIONS: A nonorganic pain drawing was a significant risk factor for inferior outcome after spinal fusion surgery. The predictive value did not allow for patient selection.

Adjacent segment degeneration after lumbar spinal fusion: the impact of anterior column support: a randomized clinical trial with an eight- to thirteen-year magnetic resonance imaging follow-up.

STUDY DESIGN: Randomized controlled trial. OBJECTIVE: To analyze long-term adjacent segment degeneration (ASD) after lumbar fusion on magnetic resonance imaging and compare randomization groups with and without anterior column support. SUMMARY OF BACKGROUND DATA: ASD can be a long-term complication after fusion. The prevalence and the cause of ASD are not well documented, but ASD are one of the main arguments for introducing the use of motion-preserving techniques as an alternative to fusion. Anterior lumbar interbody fusion combined with posterolateral lumbar fusion (ALIF+PLF) has been proved superior to posterolateral fusion alone regarding outcome and cost-effectiveness. METHODS: Between 1996 and 1999, 148 patients with severe chronic low back pain were randomly selected for ALIF+PLF or for PLF alone. Ninety-five patients participated. ASD was examined on magnetic resonance imaging with regard to disc degeneration, disc herniation, stenosis, and endplate changes. Disc heights on radiographs taken at index surgery and at long-term follow-up were compared. Outcome was assessed by validated questionnaires. RESULTS: The follow-up rate was 76%. ASD was similar between randomization groups. In the total cohort, endplate changes were seen in 26% of the participants and correlated significantly with the presence of disc degeneration and disc herniation. Disc degeneration and dorsal disc herniation were the parameters registered most frequently and were significantly more pronounced at the first adjacent level than at the second and the third adjacent levels. Patients without disc height reduction over time were significantly younger than patients with disc height reduction. Disc degeneration and stenosis correlated significantly with outcome at the first adjacent level. CONCLUSION: The cause of the superior outcome in the group with anterior support is still unclear. Compared with the findings reported in the literature, the prevalence of ASD is likely to be in concordance with the expected changes in a nonoperated symptomatic population and therefore not accelerated by fusion.

Impact of instrumentation in lumbar spinal fusion in elderly patients: 71 patients followed for 2-7 years.

BACKGROUND AND PURPOSE: An increasing number of lumbar fusions are performed using allograft to avoid donor-site pain. In elderly patients, fusion potential is reduced and the patient may need supplementary stability to achieve a solid fusion if allograft is used. We investigated the effect of instrumentation in lumbar spinal fusion performed with fresh frozen allograft in elderly patients. METHODS: 94 patients, mean age 70 (60-88) years, who underwent posterolateral spinal fusion either non-instrumented (51 patients) or instrumented (43 patients) were followed for 2-7 years. Functional outcome was assessed with the Dallas pain questionnaire (DPQ), the low back pain rating scale pain index (LBPRS), and SF-36. Fusion was assessed using plain radiographs. RESULTS: Instrumented patients had statistically significantly better outcome scores in 6 of 7 parameters. Fusion rate was higher in the instrumented group (81% vs. 68%, p = 0.1). Solid fusion was associated with a better functional outcome at follow-up (significant in 2 of 7 parameters). 15 patients (6 in the non-instrumented group and 9 in the instrumented group) had repeated lumbar surgery after their initial fusion procedure. Functional outcome was poorer in the group with additional spine surgeries (significant in 4 of 7 parameters). INTERPRETATION: Superior outcomes after lumbar spinal fusion in elderly patients can be achieved by use of instrumentation in selected patients. Outcome was better in patients in which a solid fusion was obtained. Instrumentation was associated with a larger number of additional surgeries, which resulted in a lesser degree of improvement. Instrumentation should not be discarded just because of the age of the patient.

Alendronate treatment does not inhibit bone formation within biphasic calcium phosphate ceramics in posterolateral spinal fusion: an experimental study in porcine model.

BACKGROUND: Biphasic calcium phosphate (BCP) ceramics has a potential advantage as an osteoconductive matrix and has an optimal resorption rate for bone formation. Using BCP ceramics as a bone graft during spinal fusion requires osteogenesis within the material and subsequent bridging between adjacent vertebrae to provide long-term support. Bisphosphonates have been reported to prolong the process of bone healing. The influence of bisphosphonate treatment on bone formation within BCP ceramics in spinal fusion remains unknown. The aim of this study was to evaluate the influence of alendronate on BCP osteogenesis in posterolateral spinal fusion. METHODS: Posterolateral spinal fusion with pedicle screw fixation was performed at the lumbar spine in twenty-two pigs. BCP ceramics were applied as a bone graft to obtain bone fusion between adjacent transverse processes. Eleven pigs in the treatment group received oral alendronate 10 mg/d for three months postoperatively. Eleven pigs in the control group did not receive treatment with alendronate. All animals underwent posterolateral spinal fusion with BCP ceramics. The fusion rate was evaluated three months after the operation. RESULTS: The fusion rates evaluated by X-ray were 27.3% in the treatment group and 20% in the control group. The fusion rates using histological evaluation were 18.2% in the treatment group and 20% in the control group. The mean volumes of fusion mass were (3.64 +/- 0.86) cm(3) in the treatment group and (4.26 +/- 0.63) cm(3) in the control group. No significant differences were found in either trabecular bone volume or residual BCP volume between treatment and control groups using histological evaluation. The new bone formation within BCP ceramics was greater in the area adjacent to transverse process (P < 0.01). CONCLUSION: Oral alendronate with a dose of 10 mg daily do not inhibit bone formation within BCP ceramics or affect the fusion rate in posterolateral spinal fusion from porcine models.

The effect of electrical stimulation on lumbar spinal fusion in older patients: a randomized, controlled, multi-center trial: part 1: functional outcome.

STUDY DESIGN: Randomized, controlled, multi-center trial. OBJECTIVE: To investigate the effect of direct current (DC) electrical stimulation on functional and clinical outcome after lumbar spinal fusion in patients older than 60 years. SUMMARY OF BACKGROUND DATA: Older patients have increased complication rates after spinal fusion surgery. Treatments which have the possibility of enhancing functional outcome and fusion rates without lengthening the procedure could prove beneficial. DC-stimulation of spinal fusion has proven effective in increasing fusion rates in younger and "high risk" patients, but functional outcome measures have not been reported. METHODS: A randomized, clinical trial comprising 5 orthopedic centers. The study included a total of 107 patients randomized to uninstrumented posterolateral lumbar spinal fusion with or without DC-stimulation. Functional outcome was assessed using Dallas Pain Questionnaire, SF-36, Low Back Pain Rating Scale pain index, and walking distance. RESULTS: Follow-up after 1 year was 95/107 (89%). DC-stimulated patients had significant better outcome in 3 of 4 categories in the Dallas Pain Questionnaire, better SF-36 scores (not significantly), but no difference in pain scores were observed. Median walking distance at latest follow-up was better in the stimulated group (not significant). Walking distance was significantly associated with functional outcome. There was no difference in any of the functional outcome scores between patients who experienced a perioperative complication and those without complications. CONCLUSION: The achievement of a good functional outcome was heavily dependent on the obtained walking distance. DC-stimulated patients tended to have better functional outcome as compared to controls. No negative effects of perioperative complications could be observed on the short-term functional outcome.

The effect of electrical stimulation on lumbar spinal fusion in older patients: a randomized, controlled, multi-center trial: part 2: fusion rates.

STUDY DESIGN: Randomized, controlled, multi-center trial. OBJECTIVE: To investigate the effect of direct current (DC) electrical stimulation on fusion rates after lumbar spinal fusion in patients older than 60 years. SUMMARY OF BACKGROUND DATA: Older patients have increased complication rates after spinal fusion surgery. Treatments which have the possibility of enhancing functional outcome and fusion rates without lengthening the procedure could prove beneficial. DC-stimulation of spinal fusion has proven effective in increasing fusion rates in younger and "high risk" patients, but little information exist on the effect in older patients. METHODS: A randomized clinical trial comprising 5 orthopedic centers. The study included a total of 107 patients randomized to uninstrumented posterolateral lumbar spinal fusion with or without DC-stimulation. Fusion rate was assessed at 2 year follow-up using thin slice CT. Functional outcome was assessed using Dallas Pain Questionnaire and Low Back Pain Rating Scale pain index. RESULTS.: Available follow-up after 2 years was 89% (84 of 95 patients). Fusion rates were surprisingly low. DC-stimulation had no effect on fusion rate: 35% versus 36% in controls. Other factors associated with low fusion rates were female gender (32% vs. 42% in males, P = 0.050) and smoking (21% vs. 42% in nonsmokers, P = 0.079). Patients who achieved a solid fusion as determined by CT had superior functional outcome and pain scores at their latest follow-up. CONCLUSION: Thin slice CT revealed very high nonunion rates after uninstrumented spinal fusion in older patients. DC-stimulation was not effective in increasing fusion rates in this patient population. The achievement of a solid fusion was associated with superior functional outcome.

Determinants of cost-effectiveness in lumbar spinal fusion using the net benefit framework: a 2-year follow-up study among 695 patients.

Up to one third of patients undergoing lumbar spinal fusion show no improvement after the procedure and thus, despite evidence from RCTs, there might be a rationale for observational studies clarifying indications. Similarly, selection of the right patients for the right procedure could have significant impact on cost-effectiveness, which in some countries, in turn, affects whether procedures are to be available through the National Health Service. The aim of this study was to investigate determinants of cost-effectiveness in lumbar spinal fusion. An observational cohort study with 2-year follow-up was conducted: 695 patients who underwent lumbar spinal fusion from 1996 to 2002 were included and followed for 2 years. Patients had a localized segmental pathology and were diagnosed with MRI-verified isthmic spondylolisthesis (26%) or disc degeneration (74%). The surgical techniques were non-instrumented posterolateral fusion (14%), instrumented posterolateral fusion (54%), and circumferential fusion (32%). Societal costs and improvement in functional disability (Dallas Pain Questionnaire) were transformed into a net benefit measure. Classical linear regression of the net benefit was conducted using predictors of age, sex, diagnosis, duration of pain, smoking habits, occupational status, severity of disability, emotional distress, surgical technique, and number of levels fused. The main results were that two determinants were found to negatively influence net benefit: smoking and diagnosis, whereas two others were found to be positively associated with the net benefit: severe disability and emotional distress. In conclusion, predicting net benefit reverses the picture usually seen in studies predicting clinical outcomes, because the response variable is based on improvement over time rather than end-point measures alone. Smoking habits, diagnosis, pre-operative disability, and pre-operative emotional distress were found to be significantly associated with the net benefit of spinal fusion.