Authors: Bornemann, Rahel | Roessler, Philip P. | Rommelspacher, Yorck | Strauss, Andreas | Koch, Ernst M.W. | Pflugmacher, Robert
Article Type: Research Article
Abstract: BACKGROUND: Kyphoplasty is a proven minimally invasive procedure for the treatment of patients with osteoporotic fractures. By augmentation of fractured vertebral body, however, a very large portion of the intervertebral structures will be destroyed. With the help of a new device (Vertect Jack Device), the erection of the vertebral body will be carried out more gentle. OBJECTIVE: In the present study, the new method should be clinically tested for efficacy and safety for the first time. As a comparison results of previous treatments with kyphoplasty were used. METHODS: For Vertect Jack Device study patients with painful vertebral fractures were selected …in which conservative treatment had not yielded sufficient results. For comparison random data from the records of patients who had been treated with kyphoplasty were selected. The Vertect Jack Device was placed under the central fractures and then erected. After having restorted the vertebral height the device was removed and cement injected. Clinical and radiological examinations were carried out before and after 1,3, and 6 months. RESULTS: In the Vertect Jack Device Group the data of 40 patients were evaluated. For group 2 (kyphoplasty) 50 patients were selected. There was a significant difference in the duration of the surgery (Group 1: 27.4, Group 2: 45.9 minutes). A significant difference of 20 mm with regard to the reduction of VAS scores (0–100 mm pain intensity) was detected. Under the application of the Vertect Jack Device an average increase of 3.1 mm of vertebral height was achieved. In group 2, the erection averaged 0.4 mm. A correlation between the postoperative change of vertebral body height and VAS scores could not be detected in both groups. CONCLUSIONS: The comparative analysis of this study shows that promising results can be achieved with the augmentation of vertebral fractures with the Vertect Jack Device. When compared with kyphoplasty, advantages show in terms of targeted and thus more gentle application possibility and better pain relief over a period of 6 months after surgery. Further study results should help to demonstrate the efficacy and tolerability of the new method. Show more
Keywords: Vertect Jack Device, vertebral augmentation, kyphoplasty
DOI: 10.3233/THC-160714
Citation: Technology and Health Care, vol. 25, no. 4, pp. 739-747, 2017
Authors: Bornemann, Rahel | Roessler, Philip P. | Strauss, Andreas C. | Sander, Kirsten | Rommelspacher, Yorck | Wirtz, Dieter C. | Pflugmacher, Robert | Frey, Sönke P.
Article Type: Research Article
Abstract: BACKGROUND: Sacroiliac joint (SIJ) syndrome can cause various symptoms and may also be one reason for persistent low back pain, especially in patients with prior spinal fusions. If conservative treatments fail to improve symptoms, arthrodesis surgery can be considered. Minimally invasive approaches have emerged recently providing a good alternative to conventional methods. A novel triangular implant system (iFuse) can achieve an arthrodesis of the SIJ without the use of additional screws or bone material. OBJECTIVE: Aim of the present study was an evaluation of short-term safety and efficacy of the implant system. METHODS: Twenty-four patients were included in the study …and treated with the iFuse system. In addition to demographic data, pain intensity (visual analogue scale) and functional impairment (Oswestry-disability index) were assessed prior to surgery and 1 month, 3 months, 6 months, 12 months and 24 months thereafter. During surgery and the follow up period all adverse events were documented and the correct implant position was controlled via plain radiographs. RESULTS: VAS scores and ODI improved significantly directly after surgery from 84.3 ± 9.2 mm to 40.7 ± 9.2 mm and from 76.8 ± 9.2% to 40.7 ± 9.2 % (p < 0.001). The ODI improved further to 31 ± 5.4% after 24 months whereas the VAS improved until the 3 months examination and ten stayed constant between 27.7 mm and 26.5 mm to 27 ± 6.6 mm at 24 months. No adverse events, intraoperative complications, implant malpositioning or loosening could be recorded at any time. CONCLUSIONS: The iFuse system is an effective and safe treatment for minimally invasive surgical arthrodesis of the SIJ. Pain and functional impairment can be significantly improved. However, in addition to this case series, further controlled studies are necessary, particularly in terms of a previous spinal fusion history. Show more
Keywords: Sacroiliac joint (SIJ) syndrome, arthrodesis, minimal invasive implant
DOI: 10.3233/THC-161272
Citation: Technology and Health Care, vol. 25, no. 2, pp. 319-325, 2017
Authors: Jansen, Tom R. | Bornemann, Rahel | Roessler, Philip P. | Rommelspacher, Yorck | Strauss, Andreas C. | Frey, Sönke P. | Sander, Kirsten | Wirtz, Dieter C. | Pflugmacher, Robert
Article Type: Research Article
Abstract: BACKGROUND: Patients with lumbar degenerative disk disease (DDD) often require an interbody fusion. Several spacer systems have been developed to achieve an adequate fusion. The newly developed flexible interbody spacer system (Luna® , Benvenue Medical Inc.) expands to the disk space and is adjustable to the patient's anatomy. OBJECTIVE: Prospective monocentric evaluation of interbody fusions performed with the new system in patients with DDD to assess the device's efficacy and safety. METHODS: The study includes patients with DDD of one or two contiguous lumbar levels. All patients were treated with the new flexible cage system. To evaluate the clinical outcome, …examinations were conducted preoperatively, 6 weeks, 6 months and 12 months postoperatively. At each study visit possible implant loosening was assessed by plain radiography and any adverse events were documented. Furthermore, back pain was evaluated using the visual analogue scale (VAS), functional impairment using the Oswestry-Disability-Index (ODI) and quality of life using the SF36. RESULTS: A total of 30 patients (age: 52.8 ± 11 years, gender: 53% male) were included. None of the patients showed signs of implant loosening and the total number of adverse events was low (3%). The VAS improved significantly from 81.2 ± 9.5 mm at baseline to 28 ± 26.2 mm after 12-months (p ≤ 0.0001). The ODI also improved significantly from 57.9 ± 9.6% at baseline to 20 ± 15.6% after 12-months (p ≤ 0.0001). The physical component score (PCS) of the SF36 improved significantly ongoing from 29.2 ± 9.3 at baseline to 56.1 ± 14.9 after 12-months (p = 0.0079) and the mental component score (MCS) improved significantly from 49.2 ± 20.7 at baseline to 62.8 ± 18.9 after 12 months (p = 0.013). CONCLUSIONS: Minimal-invasive lumbar interbody fusion with the new flexible system is a safe and effective treatment method for patients with DDD. Complication rates are low and treatment leads to an improvement of pain, functional impairment and quality of life. Show more
Keywords: Degenerative disk disease, flexible interbody fusion
DOI: 10.3233/THC-161153
Citation: Technology and Health Care, vol. 24, no. 5, pp. 713-720, 2016
Authors: Breidebach, Jil B. | Koch, Ernst M.W. | Bornemann, Rahel | Roessler, Philip P. | Strauss, Andreas | Frey, Sönke P. | Wirtz, Dieter C. | Pflugmacher, Robert
Article Type: Research Article
Abstract: BACKGROUND: Low vitamin D is a major risk factor for osteoporotic fractures. Evidence also suggests correlation between deficiency and musculoskeletal pain. OBJECTIVE: Non-interventional study in patients undergoing spine surgery to investigate links between vitamin D levels and clinical features. METHODS: 25-OH vitamin D levels were assessed in two cohorts: Cohort 1 (vertebral fractures; VF) and Cohort 2 (other spinal issues; excluding VF). Lab values as well as painDETECT questionnaires, VAS and Oswestry Disability Index (ODI) were recorded. Follow-up visits were conducted a few days and 6 weeks postoperatively. RESULTS: One hundred and nine patients were enrolled. Mean VAS measured 72 …mm in Cohort 1 and 55 mm in Cohort 2. Mean vitamin D concentrations were 16.8 ± 11 ng/ml in Cohort 1 and 18.3 ± 11 ng/ml in Cohort 2. VAS and ODI significantly correlated with vitamin D levels. Median painDETECT scores were 9 in Cohort 1 and 16 in Cohort 2. Six weeks postoperatively mean VAS was 31.4 ± 28 mm in Cohort 1 and 23.3 ± 21 mm in Cohort 2. Median painDETECT scores were 5 in both cohorts. CONCLUSION: Interactions are apparent between neuropathic pain and vitamin D serum levels. Consequently, vitamin D should be monitored in all patients requiring spinal surgery. Show more
Keywords: Vitamin D level, vertebral fracture, neuropathic pain, osteoporosis, musculoskeletal pain
DOI: 10.3233/THC-171055
Citation: Technology and Health Care, vol. 26, no. 2, pp. 305-317, 2018
Authors: Struwe, Charlotte | Hermann, Pia C. | Bornemann, Rahel | Plöger, Milena | Roessler, Philip P. | Strauss, Andreas C. | Rommelspacher, Yorck | Koch, Ernst M.W. | Pflugmacher, Robert
Article Type: Research Article
Abstract: BACKGROUND: Spinal fusion surgery has become one of the most common spinal procedures during the recent years. Searching for an optimum structural stability of the vertebral interspace, surgical implants which can be inserted via a posterior lumbar interbody fusion (PLIF) approach have been enhanced recently. OBJECTIVE: Evaluation of safety and efficacy of a novel PLIF polyetheretherketone (PEEK) interbody cage (TWIST) with an impactionless insertion technique. METHODS: Surgical outcome in 15 patients treated with the new system were observed preoperatively, one and three years after surgery using the Oswestry Disability Index (ODI), a Visual Analogue Scale (VAS) for pain and radiological …outcome analysis of fusion success. RESULTS: Fifteen patients (7 female, 8 male) were included in the test series. After three years ODI and VAS were significantly improved. The pain intensity was reduced by more than 75% after one year and after 3 years, pain intensity was about 60% below the initial situation. The Oswestry values (ODI) improved significantly in all patients after 3 years. The fusion evaluation showed a fusion success in 87% of the patients. CONCLUSION: The clinical and radiological results of this first series give a positive standing and important information on the efficacy and safety over 3 years. The follow-up checks with imaging techniques showed that the fusions were very successful and functional outcome as well as pain reduction were increased. Show more
Keywords: Spine, chronic low back pain, posterior lumbar interbody fusion (PLIF), interbody cage
DOI: 10.3233/THC-160721
Citation: Technology and Health Care, vol. 25, no. 5, pp. 949-957, 2017
