Biomedical subjects

Rudolf Bertagnoli

Publications and source records attributed to Rudolf Bertagnoli.

15 recordsLinked to original sources

PubMed2006

Lumbar total disc arthroplasty utilizing the ProDisc prosthesis in smokers versus nonsmokers: a prospective study with 2-year minimum follow-up.

STUDY DESIGN: Prospective nonrandomized clinical series. OBJECTIVES: To evaluate the efficacy of ProDisc lumbar artificial disc replacement (ADR) in smokers versus nonsmokers. SUMMARY OF BACKGROUND DATA: Smoking is a negative predictor in fusion surgery. To date, a prospective study of the treatment of incapacitating discogenic low back pain using ADR in smokers versus nonsmokers has not been described. METHODS: A prospective analysis was performed on 104 patients with disabling discogenic low back pain treated with single-level lumbar ProDisc total disc arthroplasty. Smokers and nonsmokers were assessed before surgery and after surgery using patient satisfaction, Oswestry, and Visual Analog Scores. Additionally, preoperative and postoperative neurologic, radiographic, and pain medication assessments were performed at similar postoperative intervals. RESULTS: Oswestry, Visual Analog Scores, and patient satisfaction scores revealed statistical improvement beginning 3 months after surgery and were maintained at minimum 2-year follow-up. Patient satisfaction scores were higher in smokers (94%) than in nonsmokers (87%) at 2-year follow-up (P = 0.07). Radiographic analysis revealed an affected disc height increase from 4 mm to 13 mm (P < 0.05) and an affected disc motion from 3 degrees to 7 degrees (P < 0.05). No cases of loosening, dislodgment, mechanical failure, infection, or fusion of the affected segment occurred. CONCLUSIONS: The results of our study indicate that smokers do equally well compared with nonsmokers when ProDisc ADR is used in the treatment of debilitating lumbar spondylosis. Patient outcome and radiographic scores showed significant improvement compared with preoperative levels. Although not evident in our series, additional surveillance for intraoperative and postoperative vascular spasm and occlusion may be warranted in smokers.

Adolescent↗

PubMed2006

Lumbar total disc arthroplasty in patients older than 60 years of age: a prospective study of the ProDisc prosthesis with 2-year minimum follow-up period.

OBJECT: The authors conducted a prospective longitudinal study to obtain outcome (minimum follow-up period 2 years) regarding the safety and efficacy of single-level lumbar disc (ProDisc prosthesis) replacement in patients 60 years of age or older. METHODS: This prospective analysis involved 22 patients treated in whom the lumbar ProDisc prosthesis was used for total disc arthroplasty. All patients presented with disabling discogenic low-back pain (LBP) with or without radicular pain. The involved segments ranged from L-2 to S-1. Patients in whom there was no evidence of radiographic circumferential spinal stenosis and with minimal or no facet joint degeneration were included. Patients were assessed preoperatively and outcome was evaluated postoperatively at 3, 6, 12, and 24 months by administration of standardized tests (the visual analog scale [VAS], Oswestry Disability Index [ODI], and patient satisfaction). Secondary parameters included analysis of pre- and postoperative radiographic results of disc height at the affected level, adjacent-level disc height and motion, and complications. Twenty-two (100%) fulfilled all follow-up criteria. The median age of all patients was 63 years (range 61-71 years). There were 17 single-level cases, four two-level cases, and one three-level case. Statistical improvements in VAS, ODI, and patient satisfaction scores were observed at 3 months postoperatively. These improvements were maintained at 24-month follow-up examination. Patient satisfaction rates were 94% at 24 months (compared with 95% reported in a previously reported ProDisc study). Radicular pain also decreased significantly. Patients in whom bone mineral density was decreased underwent same-session vertebroplasty following implantation of the ProDisc device(s). There were two cases involving neurological deterioration: unilateral foot drop and loss of proprioception and vibration in one patient and unilateral foot drop in another patient. Both deficits occurred in patients in whom there was evidence preoperatively of circumferential spinal stenosis. There were two cases of implant subsidence and no thromboembolic phenomena. CONCLUSIONS: Significant improvements in patient satisfaction and ODI scores were observed by 3 months postoperatively and these improvements were maintained at the 2-year follow-up examination. Although the authors' early results indicate that the use of ProDisc lumbar total disc arthroplasty in patients older than 60 years of age reduces chronic LBP and improves clinical functional outcomes, they recommend the judicious use of artificial disc replacement in this age group. Until further findings are reported, the authors cautiously recommend the use of artificial disc replacement in the treatment of chronic discogenic LBP in patients older than age 60 years in whom bone quality is adequate in the absence of circumferential spinal stenosis.

Age Factors↗

PubMed2006

Treatment of symptomatic adjacent-segment degeneration after lumbar fusion with total disc arthroplasty by using the prodisc prosthesis: a prospective study with 2-year minimum follow up.

OBJECT: The authors conducted a prospective longitudinal study to assess the efficacy of ProDisc arthroplasty in patients in whom symptomatic adjacent-segment degeneration has developed after remote lumbar fusion. The follow-up period was a minimum of 2 years. METHODS: The 20 patients in this study ranged in age from 18 to 67 years. They presented with disabling adjacent-level discogenic low-back pain with or without L1-S1 radicular pain. Patients with radiographic evidence of circumferential spinal stenosis or facet joint degeneration had been excluded. Patients were assessed preoperatively and postoperatively at 3, 6, 12, and 24 months. Eighteen patients (90%) fulfilled all follow-up criteria. The median age of all patients was 50 years. Statistical improvements in visual analog scale, Oswestry Disability Index, and patient satisfaction scores were documented 3 months after arthroplasty. These improvements remained at the 24-month follow-up examinations. Patient satisfaction rates were 86% at 24 months. Radicular pain was also significantly decreased. No additional surgeries were necessary at affected or unaffected levels. CONCLUSIONS: Analysis of early results indicates that ProDisc lumbar total disc arthroplasty is an efficacious treatment for symptomatic adjacent-segment lumbar discogenic low-back pain following remote fusion. Significant improvements in patient satisfaction and disability scores were observed by 3 months postoperatively and were maintained at the 2-year follow-up examination. No device-related complications occurred. Patients should be screened carefully for evidence of facet joint impingement/degeneration, hardware-induced pain, and/or nonunion at prior fusion levels before undergoing disc replacement surgery.

Adolescent↗

PubMed2005

The treatment of disabling multilevel lumbar discogenic low back pain with total disc arthroplasty utilizing the ProDisc prosthesis: a prospective study with 2-year minimum follow-up.

STUDY DESIGN: Prospective, longitudinal minimum 2-year follow-up. OBJECTIVE: To assess the efficacy and safety of the Prodisc implant in patients with disabling multilevel discogenic low back pain (LBP). SUMMARY OF BACKGROUND DATA: Few, if any, alternatives have been proposed to treat recalcitrant and debilitating multilevel lumbar discogenic low back pain. To date, a prospective study specifically examining the use of multilevel Prodisc total disc arthroplasty has not been described. METHODS: A prospective analysis was performed on 25 patients (63 prostheses) treated with multilevel lumbar ProDisc total disc arthroplasty. Minimum follow-up was 2 years. Patients 18 to 60 years of age with disabling discogenic low back pain and minimal radicular pain secondary to multiple level lumbar spondylosis from L1 to S1 were included. Preoperative and postoperative disability and pain scores were measured using Oswestry and visual analog scores. Preoperative and postoperative neurologic, radiographic, and pain medication assessments were also performed at similar postoperative intervals. RESULTS: A total of 29 patients (72 prostheses) were enrolled in the prospective analysis. Twenty-five patients (63 prostheses) fulfilled all follow-up criteria and are included for final analysis. Fifteen bisegmental and 10 trisegmental level cases were performed. Visual analog pain, Oswestry, and patient satisfaction scores were significantly reduced at the 3-month as well as at 48-month follow-up. Radiographic analysis revealed an affected disc height increases from 5 mm to 12 mm (P < 0.05) and affected disc motions from 3 degrees to 7 degrees (P < 0.05). No change in adjacent level disc heights was seen. Complications included a single case of subsidence of the inferior endplate of the L4-L5 segment in a bisegmental L4-L5/L5-S1 case. We also report a delayed case of anterior extrusion of a polyethylene component in a patient who had sustained a fall of a bicycle. CONCLUSIONS: Our preliminary data on multisegmental ProDisc lumbar total disc arthroplasty appear to be a safe and efficacious treatment method for debilitating lumbar spondylosis without significant facet arthropathy. In our select (non-Workers Compensation and/or medical legal) cohort of patients, we demonstrate a patient satisfaction rate of 93%. Careful and appropriate patient selection is essential in ensuring optimal surgical outcomes.

Adult↗

PubMed2005

The treatment of disabling single-level lumbar discogenic low back pain with total disc arthroplasty utilizing the Prodisc prosthesis: a prospective study with 2-year minimum follow-up.

STUDY DESIGN: Prospective, longitudinal minimum 2-year follow-up. OBJECTIVE: To assess the efficacy and safety of the Prodisc implant in patients with disabling single-level discogenic low back pain (LBP). SUMMARY OF BACKGROUND DATA: The treatment of debilitating discogenic LBP has been controversial and varied. To date, a longitudinal prospective study of the treatment of single-level incapacitating discogenic LBP using the Prodisc total disc arthroplasty technique has not been described. METHODS: A prospective analysis was performed on 118 patients treated with single-level lumbar Prodisc total disc arthroplasty. Patients 18 to 60 years of age with disabling and recalcitrant discogenic LBP with or without radicular pain secondary to single-level discogenic LBP from L3 to S1 were included. Patients were assessed before surgery, and outcome measurements were after surgery administered at 3, 6, 12, and 24 months. RESULTS: A total of 104 patients (88%) fulfilled all follow-up criteria. The median age of all patients was 47 years (range, 36-60 years). Statistical improvements in VAS, Oswestry, and patient satisfaction scores occurred 3 months postoperatively. These improvements were maintained at the 24-month follow-up. Radicular pain also decreased significantly. Full-time and part-time work rates increased from 10% to 35% and 3% to 24%, respectively. No additional fusion surgeries were necessary either at the affected or unaffected levels. Radiographic analysis revealed an affected disc height increase from 4 mm to 13 mm (P < 0.001) and an affected disc motion from 3 degrees to 7 degrees (P < 0.004). CONCLUSIONS: Single-level Prodisc lumbar total disc arthroplasty is a safe and efficacious treatment method for debilitating lumbar discogenic LBP. Significant improvements in patient satisfaction and disability scores occurred after surgery by 3 months and were maintained at the 2-year follow-up. No device-related complications occurred. Patients with severe to moderate disc height loss as well as those with symptomatic posterior anular defects with minimal disc height loss achieve functional gains and significant pain relief. Careful and appropriate patient selection is essential in ensuring optimal surgical outcomes.

Adult↗

PubMed2005

Clinical results of an open prospective study of a bis-GMA composite in percutaneous vertebral augmentation.

In this open prospective trial, 53 patients with acute pain from osteoporotic vertebral fracture related to osteoporosis or malignancy underwent vertebral augmentation with a new bisphenol-a-glycidyl dimethacrylate (bis-GMA) resin (Cortoss, Orthovita, Malvern, Pa, USA). Treatment consisted of up to 8 ml of Cortoss injected into a given vertebra. The procedure encompassed single and multiple injections (including the contralateral hemivertebra, to a maximum of 3 vertebral levels). Follow-up was at 4 and 8 days and at 1, 3, and 6 months. The primary efficacy end point was patient-rated pain using a 100-point visual analog scale (VAS, with 100 as severest pain) on day 4 following treatment; secondary end points were analgesic use and quality-of-life and disability scores from the Oswestry Disability Index (ODI) and a short-form 12-item questionnaire (SF-12). The present report contains interim results collected up to the 1-month post-treatment time point. At baseline, the group's mean VAS score was 69, indicating moderate to severe pain; at day 4, 32 of 53 patients (60.4%) reported a 30% or greater reduction in baseline pain accompanied by a VAS pain score less than 50 (mean 38.1). Pain reduction was maintained at 1 month (mean VAS 31.3). The average ODI score at baseline was 55, suggesting significant disability among participants prior to Cortoss treatment. Following treatment, the ODI scores were significantly reduced from these baseline levels (day 8, 47.4; 1 month, 33.6). Further, SF-12 physical and mental component scores at 1 month after treatment increased from baseline by 26% and 11%, respectively; while analgesic use decreased concomitantly, primarily among patients with underlying osteoporosis. A total of 20 adverse events were deemed to be device-related. The most frequent clinically significant adverse events attributed to Cortoss were leakage of Cortoss from within the vertebral body at placement (12%), back pain (7%), and unspecified pain (7%). These results indicate that vertebral augmentation with Cortoss rapidly reduces pain, decreases disability, and improves physical functioning in patients with painful vertebral compression fractures.

Adult↗

PubMed2005

Cervical total disc replacement, part two: clinical results.

This article focuses on the clinical results of three prostheses (the Bryan Cervical Disc, the Bristol Disc, and the ProDisc-C) for cervical total disc replacement. Background on the development, design, and biomechanical characteristics of each prosthesis is given and surgical indications and clinical results are summarized and analyzed.

Adult↗

PubMed2005

Standard and minimally invasive approaches to the spine.

With the advent of minimally invasive surgical approaches to the spine, the ability to adequately expose the desired anatomic structures while minimizing the disadvantages of excessive soft tissue stripping, dissection, and prolonged retraction has become increasingly popular. A minimally invasive one- or two-level posterior exposure of the spine is now safely attainable with the latest minimal-access systems that exploit the biomechanics of an adjustable blade retractor. As the clinical use of these developing systems escalates, more outcomes data will become available to determine the safety and value of these minimally invasive procedures.

Cervical Vertebrae↗

PubMed2005

Hybrid constructs.

Hybrid constructs can combine motion-preserving technologies with each other or motion-preserving technologies with fusion techniques. Hybrid constructs can be implanted in single-stage or multistage surgeries. Early results are promising. Further study under formal scientific conditions is necessary to explore the benefit of these combinations.

Adult↗

PubMed2005

Complications and strategies for revision surgery in total disc replacement.

Spinal arthroplasty is an acceptable alternative to fusion in many cases of disabling degenerative disc disease. Although arthroplasty has been demonstrated to be a safe and efficacious surgical option, complications related to the approach or the device may occur in few cases. Revision strategies for failed total disc arthroplasty can be planned as a posterior fusion, leaving the total disc replacement device in place, or by way of anterior removal with subsequent anterior fusion or revision replacement of the prosthesis.

Adult↗

PubMed2005

Lumbar partial disc replacement.

On the basis of the anatomy of the disc, the nucleus as pain generator and the resulting treatment possibility using nucleus replacement technologies are reviewed. Various devices are presented, from the first historical steps to treatment possibilities in the future. Clinical experiences of the widely-used PDN prosthetic device are analyzed.

Arthroplasty, Replacement↗

PubMed2005

Early results after ProDisc-C cervical disc replacement.

OBJECT: Cervical anterior decompression and total-disc replacement is currently being investigated as an alternative treatment in patients with symptomatic intervertebral cervical spondylosis with and without radiculopathy. The authors prospectively investigated the safety and efficacy of using the ProDisc-C disc for cervical arthroplasty in the treatment of symptomatic cervical spondylosis. METHODS: Sixteen patients in whom a diagnosis of symptomatic cervical spondylosis had been established were prospectively treated with complete anterior cervical discectomy and ProDisc-C cervical disc arthroplasty. Overall 12 single- and four two-level procedures were performed (20 prostheses). Patients underwent pre- and multiple postoperative assessments (3 and 6 weeks and 3, 6, and 12 months). The median age of all patients was 50 years (range 32-60 years). Levels of surgery included seven C5-6, six C6-7, and three C4-5. Neck and arm pain as well as disability scores were significantly improved by 3 months and remained significantly improved at 1 year. No additional fusion surgeries were necessary at the affected or unaffected levels. Radiography revealed an affected disc motion from 4 to 12 degrees. No surgery- or device-related complications were documented. CONCLUSIONS: Analysis of preliminary results involving ProDisc-C arthroplasty indicates significant improvement in pain and functional outcome scores. No spontaneous fusions at the level of surgery or at adjacent levels were noted. Long-term follow-up studies will be necessary before more definitive treatment recommendations can be formulated.

Adult↗

PubMed2002

Indications for full prosthetic disc arthroplasty: a correlation of clinical outcome against a variety of indications.

In this prospective study, a total of 134 prosthetic discs were replaced in 108 patients undergoing total disc replacement surgeries for degenerative disc disease. It was the aim of this study to correlate the clinical findings and the outcome of our patients treated with Prodisc II prostheses for various indications and to formulate indication criteria for disc replacement surgeries. The discs were implanted at L5/S1 in 61 patients, L5/L6 in 3 patients, L4/L5 in 31 patients, L3/L4 in 7 patients, and L2/L3 in 3 patients. There were 12 patients with two-level implants: from L4 to S1 in 11 of them and from L2 to L5 in the remaining one. Two patients also had three-level implants, from L3 to S1. Follow-up evaluation included plain radiographs, physical evaluation, and subjective evaluation by the patient using the Oswestry scale, the visual analog pain scale, and the SF-36V2 well-being questionnaire. The evaluation exercise showed that 90.8% of patients had excellent results, 7.4% had good results and 1.8% had fair results, with no poor results seen. Postoperatively, the average vertebral motion was increased in all patients at the operated level. Progression of disc degeneration at the adjacent levels was noted in ten patients. The average time to resuming activities of daily living unaided was 2.3 weeks. No implant failures or complications due to surgery were encountered in this study. Total prosthesis disc replacement for degenerative disc disease was found to be a good treatment modality, provided proper patient selection and criteria are adhered to. We were able to formulate indication criteria based on this.

Adult↗

PubMed2002

Circumferential fusion of the lumbar and lumbosacral spine using a carbon fiber ALIF cage implant versus autogenous bone graft: a comparative study.

This study reports on 92 patients treated with circumferential lumbar fusions for degenerative conditions. The elected procedure was a circumferential fusion using transpedicular stabilization. Two groups were examined depending on whether they were stabilized anteriorly with autogenous bicortical iliac crest graft (n = 38) or with an ALIF carbon fiber cage implant (n = 54). The patients were evaluated for clinical and radiographic outcome. The minimum follow-up interval was at least 12 months. Fusion rates, postoperative loss of correction, and clinical results, including pain at the bone donor site, neurologic function, satisfaction, depression, and consumption of analgesics, were not significantly different between patients with autogenous bone graft and patients with carbon cage. This study failed to prove major advantages of the carbon cages in the clinical and radiologic outcome.

Adolescent↗

PubMedDate not supplied

Mechanical testing of a novel hydrogel nucleus replacement implant.

BACKGROUND CONTEXT: Both total disc and nucleus replacement arthroplastic approaches are emerging as viable treatment modalities for discogenic pain resulting from degenerative disc disease. The results of the testing in this investigation show that this novel nucleus replacement implant exhibits physical and mechanical properties which make it uniquely suitable as a replacement to the degenerated nucleus pulposus. PURPOSE: The purpose of this investigation was to evaluate key performance characteristics of a novel nucleus replacement device. STUDY DESIGN: Mechanical tests were performed to evaluate essential properties of the implant. Of key importance was the ability of the implant to withstand fatigue testing and resist extrusion in cadaveric motion segments. Resistance of the implant to radial deformation is also relevant to the ability of the implant to resist extrusion and maintain disc height. METHODS: Resistance to radial bulging was demonstrated by applying axial compressive loads while examining the "footprint" of the implant through a clear plexiglass lower platen. A NeuDisc implant was compared with an isotropic implant produced from the same hydrolyzed polyacrylonitrile hydrogel. Confined compression tests were used to determine "lifting force" when implants were loaded within stainless steel cylinders submerged in Hanks' balanced salt solution. Fatigue tests involved loading for 10 million cycles. Implants were then examined for physical damage, retention of mechanical properties, and for the ability of the device to return to a complete level of hydration. The final evaluation was extrusion testing in a cadaveric model. Implanted specimens were either tested in compression, lateral bending, or flexion until catastrophic failure was apparent. RESULTS: The NeuDisc implant showed considerably less "bulging" when compared with the identically sized isotropic device. Confined compression testing revealed a lifting force of 400 N at 70% hydration for these hydrogel implants. After fatigue testing, all implants were physically intact and possessed similar swelling characteristics to control samples. In cadaver testing, mean force to failure in compression was 3581.3+/-1558.5 N. Mean moment to failure in lateral bending was 25.6+/-11.1 Nm. In flexion tests, the mean moment to failure was 52.2+/-18.3 Nm. End plate fracture and ligament failure were the most commonly observed failure modes. CONCLUSIONS: These initial results suggest that this novel implant may prove to be a suitable nucleus pulposus substitute.

Adult↗