Benchmarking in the SWISSspine Registry: results of 52 Dynardi lumbar total disc replacements compared with the data pool of 431 other lumbar disc prostheses

The SWISSspine registry is the first mandatory registry of its kind in the history of Swiss orthopaedics and it follows the principle of "coverage with evidence development”. Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. Recently, developed and clinically implemented, the Dynardi total disc arthroplasty (TDA) accounted for 10% of the implanted lumbar TDAs in the registry. We compared the outcomes of patients treated with Dynardi to those of the recipients of the other TDAs in the registry. Between March 2005 and October 2009, 483 patients with single-level TDA were documented in the registry. The 52 patients with a single Dynardi lumbar disc prosthesis implanted by two surgeons (CE and OS) were compared to the 431 patients who received one of the other prostheses. Data were collected in a prospective, observational multicenter mode. Surgery, implant, 3-month, 1-year, and 2-year follow-up forms as well as comorbidity, NASS and EQ-5D questionnaires were collected. For statistical analyses, the Wilcoxon signed-rank test and chi-square test were used. Multivariate regression analyses were also performed. Significant and clinically relevant reduction of low back pain and leg pain as well as improvement in quality of life was seen in both groups (P<0.001 postop vs. preop). There were no inter-group differences regarding postoperative pain levels, intraoperative and follow-up complications or revision procedures with a new hospitalization. However, significantly more Dynardi patients achieved a minimum clinically relevant low back pain alleviation of 18 VAS points and a quality of life improvement of 0.25 EQ-5D points. The patients with Dynardi prosthesis showed a similar outcome to patients receiving the other TDAs in terms of postoperative low back and leg pain, complications, and revision procedures. A higher likelihood for achieving a minimum clinically relevant improvement of low back pain and quality of life in Dynardi patients was observed. This difference might be due to the large number of surgeons using other TDAs compared to only two surgeons using the Dynardi TDA, with corresponding variations in patient selection, patient-physician interaction and other factors, which cannot be assessed in a registry stud

Safety and efficacy of stand-alone anterior lumbar interbody fusion in low-grade L5-S1 isthmic spondylolisthesis.

Introduction Surgical management of isthmic spondylolisthesis is controversial and reports on anterior approaches in the literature are scarce. Research question To evaluate the safety and efficacy of stand-alone anterior lumbar interbody fusion (ALIF) in patients with symptomatic low-grade L5-S1 isthmic spondylolisthesis. Material and methods All adult patients with isthmic spondylolisthesis of the lumbosacral junction treated in a single institution between 2008 and 2019 with stand-alone ALIF were screened. A titan cage was inserted at L5-S1 with vertebral anchoring screws. Prospectively collected surgical, clinical and radiographic data were analyzed retrospectively. Results 34 patients (19 men, 15 women, mean age 52.5 ​± ​11.5 years) with a mean follow-up of 3.2 (±2.5) years were analyzed. 91.2% (n ​= ​31) of patients had a low-grade spondylolisthesis and 8.8% (n ​= ​3) grade III according to Meyerding classification. Mean COMI and ODI scores improved significantly from 6.9 (±1.5) and 35.5 (±13.0) to 2.0 (±2.5) and 10.2 (±13.0), respectively after one year, and to 1.7 (±2.5) and 8.2 (±9.6), respectively, after two years. The COMI and ODI scores improved in 86.4% and 80%, respectively, after one year and 92.9% of patients after two years by at least the minimal clinically important difference. No intraoperative complications were recorded. 8.8% (n ​= ​3) of patients needed a reoperation. Discussion and conclusion After stand-alone ALIF for symptomatic isthmic spondylolisthesis, the patients improved clinically important after one and two years. Stand-alone ALIF is a safe and effective surgical treatment option for low-grade isthmic spondylolisthesis

Long-Term Outcome After Monosegmental L4/5 Stabilization for Degenerative Spondylolisthesis With the Dynesys Device

STUDY DESIGN:: retrospective analysis of prospectively collected clinical data. OBJECTIVE:: To assess the long-term outcome of patients with monosegmental L4/5 degenerative spondylolisthesis treated with the dynamic Dynesys device. SUMMARY OF BACKGROUND DATA:: The Dynesys® system has been used as a semirigid, lumbar dorsal pedicular stabilization device since 1994. Good short-term results have been reported, but little is known about the long-term outcome following treatment for degenerative spondylolisthesis at the L4/5 level. METHODS:: 39 consecutive patients with symptomatic degenerative lumbar spondylolisthesis at the L4/5 level were treated with bilateral decompression and Dynesys instrumentation. At a mean follow-up of 7.2 years (range 5.0-11.2▒y) they underwent clinical and radiographic evaluation and quality of life assessment. RESULTS:: At final follow-up back pain improved in 89% and leg pain improved in 86% of patients compared to preoperative status. 83% of patients reported global subjective improvement. 92% would undergo the surgery again. 8 patients (21%) required further surgery due to symptomatic adjacent segment disease (6 cases), late onset infection (1 case), and screw breakage (1 case). In 9 cases radiological progression of spondylolisthesis at the operated segment was found. 74% of operated segments showed limited flexion-extension range of less than 4°. Adjacent segment pathology, though without clinical correlation, was diagnosed at the L5/S1 (17.9%) and L3/4 (28.2%) segments. In 4 cases asymptomatic screw loosening was observed. CONCLUSION:: Monosegmental Dynesys instrumentation of degenerative spondylolisthesis at L4/5 shows good long-term results. The rate of secondary surgeries is comparable to other dorsal instrumentation devices. Residual range of motion in the stabilized segment is reduced, and the rate of radiological and symptomatic adjacent segment degeneration is low. Patient satisfaction is high. Dynesys stabilization of symptomatic L4/5 degenerative spondylolisthesis is a possible alternative to other stabilization devices

Long-term Outcome After Monosegmental L4/5 Stabilization for Degenerative Spondylolisthesis With the Dynesys Device.

STUDY DESIGN Retrospective analysis of prospectively collected clinical data. OBJECTIVE To assess the long-term outcome of patients with monosegmental L4/5 degenerative spondylolisthesis treated with the dynamic Dynesys device. SUMMARY OF BACKGROUND DATA The Dynesys system has been used as a semirigid, lumbar dorsal pedicular stabilization device since 1994. Good short-term results have been reported, but little is known about the long-term outcome after treatment for degenerative spondylolisthesis at the L4/5 level. METHODS A total of 39 consecutive patients with symptomatic degenerative lumbar spondylolisthesis at the L4/5 level were treated with bilateral decompression and Dynesys instrumentation. At a mean follow-up of 7.2 years (range, 5.0-11.2 y), they underwent clinical and radiographic evaluation and quality of life assessment. RESULTS At final follow-up, back pain improved in 89% and leg pain improved in 86% of patients compared with preoperative status. Eighty-three percent of patients reported global subjective improvement. Ninety-two percent would undergo the surgery again. Eight patients (21%) required further surgery because of symptomatic adjacent segment disease (6 cases), late-onset infection (1 case), and screw breakage (1 case). In 9 cases, radiologic progression of spondylolisthesis at the operated segment was found. Seventy-four percent of operated segments showed limited flexion-extension range of <4 degrees. Adjacent segment pathology, although without clinical correlation, was diagnosed at the L5/S1 (17.9%) and L3/4 (28.2%) segments. In 4 cases, asymptomatic screw loosening was observed. CONCLUSIONS Monosegmental Dynesys instrumentation of degenerative spondylolisthesis at L4/5 shows good long-term results. The rate of secondary surgeries is comparable to other dorsal instrumentation devices. Residual range of motion in the stabilized segment is reduced, and the rate of radiologic and symptomatic adjacent segment degeneration is low. Patient satisfaction is high. Dynesys stabilization of symptomatic L4/5 degenerative spondylolisthesis is a possible alternative to other stabilization devices

Anterior Lumbar Interbody Fusion in Elderly Patients: Peri- and Postoperative Complications and Clinical Outcome.

BACKGROUND  Anterior lumbar interbody fusion (ALIF) is an effective surgical technique for treating various lumbar pathologies, but its use in elderly patients is controversial. Data concerning complications and effectiveness are sparse. We investigated peri- and postoperative complications, radiographic parameters, and clinical outcome in elderly patients. METHODS  Patients ≥65 years who underwent ALIF between January 2008 and August 2020 were included in the study. All surgeries were performed through a retroperitoneal approach. Clinical and surgical data as well as radiologic parameters were collected prospectively and analyzed retrospectively. RESULTS  A total of 39 patients were included; the mean age was 72.6 (±6.3) years (range: 65-90 years); and the mean American Society of Anesthesiologists (ASA) risk classification was 2.3 (±0.6). A laceration of the left common iliac vein was the only major complication recorded (2.6%). Minor complications occurred in 20.5% of patients. Fusion rate was 90.9%. Reoperation rate at the index level was 12.8 and 7.7% in adjacent segments. The multidimensional Core Outcome Measures Index (COMI) improved from 7.4 (±1.4) to 3.9 (±2.7) after 1 year and to 3.3 (±2.6) after 2 years. Oswestry disability index (ODI) improved from 41.2 (±13.7) to 20.9 (±14.9) after 1 year and to 21.5 (±18.8) after 2 years. Improvements of at least the minimal clinically important change score of 2.2 and 12.9 points in the ODI and COMI after 2 years were noted in 75 and 56.3% of the patients, respectively. CONCLUSION  With careful patient selection, ALIF is safe and effective in elderly patients

Benchmarking in the SWISSspine Registry: results of 52 Dynardi lumbar total disc replacements compared with the data pool of 431 other lumbar disc prostheses

The SWISSspine registry is the first mandatory registry of its kind in the history of Swiss orthopaedics and it follows the principle of “coverage with evidence development”. Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. Recently, developed and clinically implemented, the Dynardi total disc arthroplasty (TDA) accounted for 10% of the implanted lumbar TDAs in the registry. We compared the outcomes of patients treated with Dynardi to those of the recipients of the other TDAs in the registry. Between March 2005 and October 2009, 483 patients with single-level TDA were documented in the registry. The 52 patients with a single Dynardi lumbar disc prosthesis implanted by two surgeons (CE and OS) were compared to the 431 patients who received one of the other prostheses. Data were collected in a prospective, observational multicenter mode. Surgery, implant, 3-month, 1-year, and 2-year follow-up forms as well as comorbidity, NASS and EQ-5D questionnaires were collected. For statistical analyses, the Wilcoxon signed-rank test and chi-square test were used. Multivariate regression analyses were also performed. Significant and clinically relevant reduction of low back pain and leg pain as well as improvement in quality of life was seen in both groups (P < 0.001 postop vs. preop). There were no inter-group differences regarding postoperative pain levels, intraoperative and follow-up complications or revision procedures with a new hospitalization. However, significantly more Dynardi patients achieved a minimum clinically relevant low back pain alleviation of 18 VAS points and a quality of life improvement of 0.25 EQ-5D points. The patients with Dynardi prosthesis showed a similar outcome to patients receiving the other TDAs in terms of postoperative low back and leg pain, complications, and revision procedures. A higher likelihood for achieving a minimum clinically relevant improvement of low back pain and quality of life in Dynardi patients was observed. This difference might be due to the large number of surgeons using other TDAs compared to only two surgeons using the Dynardi TDA, with corresponding variations in patient selection, patient-physician interaction and other factors, which cannot be assessed in a registry study

An injectable nucleus replacement as an adjunct to microdiscectomy: 2 year follow-up in a pilot clinical study

Literature indicates that loss of disc tissue from herniation and/or surgery can accelerate degeneration of the disc. The associated loss of disc height may correspond with recurrent back and/or leg pain. A novel hydrogel has been developed to replace lost nucleus pulposus and potentially restore normal disc biomechanics following herniation and surgery. A single-center, non-randomized, prospective feasibility study was undertaken to investigate the use of NuCore® Injectable Nucleus hydrogel (Spine Wave, Inc., Shelton, CT, USA) as a replacement for nuclear tissue lost to herniation and microdiscectomy. Fourteen patients were enrolled at the authors’ hospital as the initial site in a worldwide multicenter pilot study. Subjects who were entered into the study suffered from radicular pain due to single-level herniated nucleus pulposus and were non-respondent to conservative therapy. Following a standard microdiscectomy procedure, the hydrogel material was injected into the nuclear void to replace what tissue had been lost to the herniation and surgery. Leg and back pain, function and disability scores were monitored pre- and post-operatively through 2 years. Neurologic and physical evaluations, blood and serum analyses, and radiographic evaluations of disc height and implant stability were also performed. Results showed significant improvement for leg and back pain, as well as function scores. No complications or device related adverse events were observed. MR controls confirmed stable position of the implants with no reherniations. Radiographic measurements indicated better maintenance of disc height compared to literature data on microdiscectomy alone. The NuCore® material appears to protect the disc from early collapse following microdiscectomy; and therefore, may have the potential to slow the degenerative cascade of the spinal segment over time

Segment-by-segment stabilization for degenerative disc disease: a hybrid technique

Patients with multisegmental degenerative disc disease (DDD) resistant to conservative therapy are typically treated with either fusion or non-fusion surgical techniques. The two techniques can be applied at adjacent levels using Dynesys® (Zimmer GmbH, Winterthur, Switzerland) implants in a segment-by-segment treatment of multiple level DDD. The objective of this study was to evaluate the clinical and radiological outcome of patients treated using this segment-by-segment application of Dynesys in some levels as a non-fusion device and in other segments in combination with a PLIF as a fusion device. A consecutive case series is reported. The sample included 16 females and 15 males with a mean age of 53.6 years (range 26.3–76.4 years). Mean follow-up time was 39 months (range 24–90 months). Preoperative Oswestry disability index (ODI), back- and leg-pain scores (VAS) were compared to postoperative status. Fusion success and system failure were assessed by an independent reviewer who analyzed AP and lateral X-rays. Back pain improved from 7.3 ± 1.7 to 3.4 ± 2.7 (p < 0.000002), leg pain from 6.0 ± 2.9 to 2.3 ± 2.9 (p < 0.00006), and ODI from 51.6 ± 13.2% to 28.7 ± 18.0% (p < 0.00001). Screw loosening occurred in one of a total of 222 implanted screws (0.45%). The results indicate that segment-by-segment treatment with Dynesys® in combination with interbody fusion is technically feasible, safe, and effective for the surgical treatment of multilevel DDD