|
|
|
|
|
EuroSpine 2007: Advances in spine care
|
This year’s EuroSpine meeting hosted a series of dynamic presentations given by expert spinal specialists and opinion leaders from Europe and across the globe. The annual meeting has grown from year-to-year since it’s foundation in 1998, and this year over 1,700 delegates and 100 exhibitors attended the congress, which was held in Belgium, Brussels from 2–6 October, 2007.
The stimulating scientific programme included debates, workshops and presentations including the latest clinical trial results and research. Next year, the meeting will take place in Geneva, Switzerland, as part of SpineWeek.
|
ProDisc-C: Clinical IDE trial results revealed. The purpose of cervical arthroplasty is to remove the pain generator, provide stability, restore height to the spinal segment and allow for motion, explained Dr Jeffrey A Goldstein, Director of the Spine Service, New York University Hospital for Joint Diseases, NY. His presentation, entitled, ‘Cervical disc arthroplasty with ProDisc-C: Clinic IDE trial results from five centers with 2–3 year followup’, looked at mechanical and function outcomes of the ProDisc-C (Synthes) for cervical disc replacement compared to anterior cervical discectomy and fusion (ACDF).Goldstein described the ProDisc-C as a ball and socket implant that is semi-constrained, with a fixed COR that enables controlled, predictable motion. It also relies on load sharing with collateral structures such as facet joints, muscles, ligaments and tendons. In regard to surgical technique, Goldstein said it was similar to ACDF. Like ACDF, the simple ProDisc-C procedure starts with a standard discectomy, but unlike ACDF, it is bone-preserving, with no endplate milling required and requires soft tissue ligamentous balancing. The device is CE marked, and is approved only for investigational use (IDE) in the US. The study protocol was a prospective, randomised trial investigating symptomatic cervical disc disease (SCDD) from C3–C7. The first surgery took place on August 2003 and patients were 1:1 randomised to fusion. Follow-up was two years and is now complete. The inclusion criteria involved patients with symptomatic cervical disc disease in only one vertebral level between C3–C7, and were unresponsive to non-op treatment for six weeks. Patients were aged between 18 to 60 years old. The study excluded patients with neck or arm pain of unknown etiology, marked cervical instability, severe spondylosis, osteroporosis, severe facet joint disease or degeneration and prior surgery at the treatment level. This study included 50 patients from five centres, and is a subset of the overall IDE study. The ProDisc-C device was assigned to 22 patients, and 28 received ACDF. Goldstein explained that patients were evaluated pre-op and at six weeks, three, six, 12, 18 and 24 months post-op. Patient self-assessment exams including the Neck Disability Index (NDI), SF- 36, Visual Analog Scale (VAS) Pain Frequency(neck and arm), VAS Pain Intensity (neck and arm) and VAS Satisfaction were collected at each exam. Radiographs were then obtained at each visit and range of motion (ROM) was measured. The levels that were implanted are shown in Table 1. The radiographic results showed that fusion rate for ACDF was 90.2%. The ProDisc-C patients average ROM at 24 months was 9.36 degrees. To conclude, Goldstein stated, “In appropriately selected patients, results from these five centres demonstrated that cervical disc arthroplasty with ProDisc-C is equivalent to ACDF. It is clear that patients experience significant relief in arm and neck pain following arthroplasty surgery similar to ACDF.” He continued, “NDI [neck disability index] results show consistent improvement from the pre-operative condition for the ProDisc-C group, and patients are reporting satisfaction in the 90% range in both groups consistently out to 24 months.”
|
|
|
|
There are some articles that have associated implant-related complications due to stress shielding with the constrained plate system, stated Dr A Yamazaki, Niigata Central Hospital, Japan, at the ’Cervical Spine’ session, adding that semi-constrained plates, allowing translation or rotation of the screws in the plate, have been recently introduced. Yamazaki was involved in a recent study that evaluated the usefulness of the anterior plates and compared semi-constrained plates (Premier, Medtronic) with constrained (Atlantis, Medtronic). Fifty-four patients were recruited from 1999–2005, with a follow-up of two years. Patients were allocated into three groups, those receiving no plates (Group N, n=18), those receiving constrained plates (Group C, n=16), and those receiving semi constrained plates (Group S, n=20). According to Yamazaki, the demographic data were not significantly different. Fusion level occurred from C3–C7 in varying incidences across all groups, and the average age of patients was 46, 51 and 51 for Groups N, C and S, respectively (Table 2). Next, Yamazaki described the investigated factors, such as fusion rate, local lordosis, fusion length, instrument and graft complications, and re-operation. The fusion rate, as he discussed, was continuity of trabeculae, and there was no movement between the spinous processes. The fusion rate for Group N was 94%, 80% for Group C and 95% for Group S. Complications for patients in Group N included graft displacement (n=5, 28%) and re-operation eg. anterior spine fusion (ASF, n=1) and administration of a halo crest (n=1). Complications in Group C involving graft or instrument complications included ’screw back out’ (n=3, 19%). Re-operation occurred in two patients, one who underwent ASF plus posterior spine fusion (PSF), and the other just PSF. Two patients (10%) in Group C experienced instrument complications which was cranial adjacent disc irritation due to excessive plate translation, and no patients underwent re-operation. From the results of the fusion rate in the study, the researchers discovered that the Atlantis decreased the fusion rate, and the Premier did not enhance the fusion rate, however, both plates were useful for maintaining locol lordosis and preventing graft complications (Table 3).
In summary, Yamazaki explained that the Atlantis constrained plate does not allow graft subsidence, increases mechanical stress on the screws and causes screw back out. In comparison, the Premier semi-constrained plate allows graft subsidence, decreases mechanical stress on the screws and leads to fewer complications. He added that: “The anterior plates do not significantly increase the fusion rate, maintaining local lordosis and preventing graft complications. Graft subsidence causes instrument complications in the constrained plate; therefore the semi constrained plate is preferable rather than the constrained one.”
|
|
|
|
Does post-op rehab benefit patients after surgery of the lumbar spine? The winner of the 2007 EuroSpine Award on Clinical Science was Dr Anne Mannion, Schulthess Klinik, Zurich, Switzerland, and her team, for their work on the study entitled: ’A randomised controlled trial of postoperative rehabilitation after surgical decompression of the lumbar spine’. Mannion presented the results from the study at the meeting, and began by explaining that decompression of the lumbar spine is the most common type of spinal surgery performed in the older patient, and is commonly followed by a programme of physiotherapy or rehabilitation, although the benefits of this compared with no formal rehabilitation have yet to be demonstrated in randomised controlled trials. Mannion then outlined the objective of the study, which was to examine the efficacy of rehabilitation after spinal decompression surgery (without fusion). Patients included were over 45 years of age, presented with degenerative spinal stenosis or herniated disc, and had no previous spine fusion or instrumentation. The number of patients enrolled in the study before surgery was 159. At 2-3 months after surgery, patients began their post-surgical rehabilitation in the group to which they had been randomised. The control group included 54 patients who did not undergo supervised rehabilitation but were advised to stay active. The second group (n=49) attended active physiotherapy in which mixed physiotherapeutic techniques were used, and the third group (n=56) attended physiotherapy sessions that concentrated on spine stabilisation exercises. Both physiotherapy groups experienced two, half-hour rehabilitation sessions per week for 12 weeks. Before and at various time-points after surgery all patients completed a questionnaire enquiring about their back and leg pain (on a 0 to 10-point graphic rating scale) and their selfrated disability in everyday activities due to their back problem (Roland Morris Disability). Mannion reported that there were no significant differences (i.e., sociodemographic, pain/disability, general medical, or psychological characteristics) between the groups either before surgery or before the ’rehab’ phase. She explained that, before rehab, 11 patients transferred from the physiotherapy groups into the control group, and four transferred from the control group into the physiotherapy groups, such that finally 61 patients were included in the control group and 98 in the two physiotherapy groups. Six patients dropped out of physiotherapy for various reasons, leaving a total of 92 patients who completed the rehab phase. At 24 months post-surgery, 151 patients returned their follow-up questionnaire, giving a follow-up rate of 97% of those patients still alive (N=155; four had died since the start of the study). Back and leg pain decreased significantly after surgery, but showed no further reduction throughout the 24 month follow-up, in any of the groups. Self-rated disability also declined significantly after surgery, and continued to decline throughout the 3-month postoperative rehabilitation phase, but with no significant differences between the three groups in the extent of the reduction. Mannion explained that two months after surgery, 84% of patients reported a ’good’ result, indicating that surgery ’helped’ or ’helped a lot’, while 16% reported a ’poor’ result, indicating that surgery ’helped a little’, ’didn’t help’, or ’made things worse’. Even in the small group of patients with a poor outcome, postoperative physiotherapy was not able to improve the final result compared with the controls.
Therefore, to conclude, Mannion said that with regard to all patients, "Post-operative physiotherapy did not influence the course of change in pain or disability up to 24 months after decompression surgery. Advising patients to keep active by carrying out the type of physical activities that they most enjoy appears to be just as good as administering a supervised rehabilitation programme, and at no cost to the healthcare provide." With regard to all patients with a poor surgical outcome, "Post-operative physiotherapy does not appear to be able to compensate for a poor initial surgical result," she said.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Latest News |
|
|
|
|
Features |
|
|
|
Profiles |
|
|
|
|
