Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial

2010 ◽  
Vol 13 (3) ◽  
pp. 308-318 ◽  
Author(s):  
J. Kenneth Burkus ◽  
Regis W. Haid ◽  
Vincent C. Traynelis ◽  
Praveen V. Mummaneni
Keyword(s):  
Clinical Outcomes ◽  
Surgical Procedures ◽  
Cervical Disc ◽  
Control Group ◽  
Segmental Motion ◽  
Disc Prosthesis ◽  
Treatment Groups ◽  
The Prestige

Object The purpose of this study was to determine long-term clinical outcomes in patients undergoing anterior cervical surgery in which a cervical disc prosthesis was used to treat single-level degenerative cervical disc disease. Methods In this prospective, nonblinded study, 541 patients at 32 investigational sites were randomly assigned to 1 of 2 treatment groups. The results of the investigational group, in which patients received the Prestige disc prosthesis, were compared with those of the control group, in which patients underwent an instrumented interbody fusion. Data were collected preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, and 60 months postoperatively. To date, 271 patients have completed 5 years of clinical follow-up (144 investigational and 127 control patients). Results Significant improvements in Neck Disability Index (NDI) scores, Physical Component Summary scores of the 36-Item Short-Form Health Survey, and neck and arm pain scores were achieved by 1.5 months in both groups and sustained at 5 years. The mean NDI improvements from preoperative scores were 35.4, 36.3, and 38.4 at 24, 36, and 60 months, respectively, in the investigational group. The corresponding mean NDI improvements were 33.9, 31.3, and 34.1 in the control group. The intergroup differences at both 36 and 60 months were significant (p = 0.008 and 0.022, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were 91.6%, 92.8%, and 95.0%, respectively, at 24, 36, and 60 months compared with 83.6%, 83.2%, and 88.9% in the control group (p = 0.006, 0.004, and 0.051, respectively). The implant effectively maintained angular motion, averaging more than 7.3° at 36 months and 6.5° at 60 months after surgery. No implant migration was observed up to 60 months. There were statistically significant differences between the investigational and control groups with regard to the rate of revision and supplemental fixation surgical procedures performed subsequent to the index procedure. Additional surgical procedures for adjacent-segment disease were observed in both treatment groups. Rates for surgery at adjacent levels trended lower in the investigational group (8 patients [11 surgeries]) compared with those in the control group (13 patients [16 surgeries]), but the differences were not statistically significant (p = 0.376). Some of the second surgeries involved both index and adjacent levels. Conclusions The Prestige disc maintains improved clinical outcomes and segmental motion after implantation at 5-year follow-up.

Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial

2014 ◽  
Vol 21 (4) ◽  
pp. 516-528 ◽  
Author(s):  
J. Kenneth Burkus ◽  
Vincent C. Traynelis ◽  
Regis W. Haid ◽  
Praveen V. Mummaneni
Keyword(s):  
Clinical Trial ◽  
Surgical Procedures ◽  
Neck Disability Index ◽  
Cervical Disc ◽  
Control Group ◽  
Control Groups ◽  
Neck Disability ◽  
And Control ◽  
The Prestige

Object The authors assess the long-term safety and efficacy of cervical disc replacement with the Prestige Cervical Disc in a prospective, randomized, multicenter trial at 7 years of follow-up. Methods At 31 investigational sites, 541 patients with single-level cervical disc disease with radiculopathy were randomized to 1 of 2 treatment groups: 276 investigational group patients underwent anterior cervical discectomy and arthroplasty with the Prestige disc, and 265 control group patients underwent anterior cervical discectomy and fusion. Clinical outcomes included Neck Disability Index, the 36-Item Short-Form Health Survey, and neck and arm pain scores. Radiographs were assessed for angle of motion and fusion. Clinical and radiographic outcomes were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, 60, and 84 months. Results Of the 541 patients treated, 395 patients (73%; 212 investigational and 183 control patients) completed 7 years of clinical follow-up. Significant improvements achieved by 1.5 months in both groups were sustained at 7 years. In the investigational group, mean Neck Disability Index improvements from preoperative scores were 38.2 and 37.5 at 60 and 84 months, respectively. In the control group, the corresponding means were 33.8 and 31.9. The differences between the investigational and control groups at the 60-month and 84-month periods were significant (p = 0.014 and 0.002, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were significantly higher: 92.2% and 88.2% at 60 months and 84 months, respectively, compared with 85.7% and 79.7% in the control group (p = 0.017 and 0.011, respectively). At 84 months, the percentage of working patients in the investigational group was 73.9%, and in the control group, 73.1%. Postoperatively, the implant effectively maintained average angular motion of 6.67° at 60 months and 6.75° at 84 months. Cumulative rates for surgery at the index level were lower (p < 0.001) in the investigational group (11 [4.8%] of 276) when compared with the control group (29 [13.7%] of 265) (based on life-table method), and there were statistical differences between the investigational and control groups with specific regard to the rate of subsequent revision and supplemental fixation surgical procedures. Rates for additional surgical procedures that involved adjacent levels were lower in the investigational group than in the control group (11 [4.6%] of 276 vs 24 [11.9%] of 265, respectively). Conclusions Cervical disc arthroplasty has the potential for preserving motion at the operated level while providing biomechanical stability and global neck mobility and may result in a reduction in adjacent-segment degeneration. The Prestige Cervical Disc maintains improved clinical outcomes and segmental motion after implantation at 7-year follow-up. Clinical trial registration no. NCT00642876 (ClinicalTrials.gov).

Stentless Pericarbon Freedom Versus Stented Perimount Aortic Bioprosthesis: Propensity-Matched Long-Term Follow-Up

2020 ◽  
Vol 15 (5) ◽  
pp. 440-448
Author(s):  
Guglielmo Stefanelli ◽  
Fabrizio Pirro ◽  
Vincenzo Smorto ◽  
Alessandro Bellisario ◽  
Emilio Chiurlia ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Clinical Outcomes ◽  
Large Body ◽  
Left Ventricular ◽  
Control Group ◽  
Late Mortality ◽  
Small Aortic Root ◽  
Hemodynamic Performance

Objective Stentless aortic valves have shown superior hemodynamic performance and faster left ventricular mass regression compared to stented bioprostheses. Yet, controversies exist concerning the durability of stentless valves. This case-matched study compared short- and long-term clinical outcomes of stentless LivaNova-Sorin Pericarbon Freedom™ (SPF) and stented Carpentier-Edwards Perimount (CEP) aortic prostheses. Methods From 2003 through 2006, 134 consecutive patients received aortic valve replacement with SPF at our institution. This cohort was matched, according to 20 preoperative clinical parameters, with a control group of 390 patients who received CEP prosthesis during the same time. The resulting 55 + 55 matched patients were analyzed for perioperative results and long-term clinical outcomes. Results Early mortality was 0% for both groups. Lower transvalvular gradients were found in the SPF group (10.6 ± 2.9 versus 15.7 ± 3.1 mmHg, P < 0.001). Overall late mortality (mean follow-up: 10.03 years) was similar for both groups (50.1% versus 42.8%, P = 0.96). Freedom from structural valve degeneration (SVD) at 13 years was similar for both groups (SPF = 92.3%, CEP = 73.9%, P = 0.06). Freedom from aortic valve reinterventions did not differ (SPF = 92.3%, CEP = 93.5%, P = 0.55). Gradients at 13-year follow-up remained significantly lower in SPF group (10.0 ± 4.5 versus 16.2 ± 9.5 mmHg, P < 0.001). Incidence of acute bacterial endocarditis (ABE) and major adverse cardiovascular and cerebrovascular events (MACCE) was similar. Conclusions SPF and CEP demonstrated comparable long-term outcomes related to late mortality, SVD, aortic valve reinterventions, and incidence of ABE and MACCE. Superior hemodynamic performance of SPF over time can make this valve a suitable choice in patients with small aortic root and large body surface area.

Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial

2007 ◽  
Vol 6 (3) ◽  
pp. 198-209 ◽  
Author(s):  
Praveen V. Mummaneni ◽  
J. Kenneth Burkus ◽  
Regis W. Haid ◽  
Vincent C. Traynelis ◽  
Thomas A. Zdeblick
Keyword(s):  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Control Group ◽  
Adjacent Segment ◽  
Segmental Motion ◽  
Disc Arthroplasty ◽  
Cervical Discectomy ◽  
Single Level ◽  
The Prestige

Object The authors report the results of a prospective randomized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical degenerative disc disease (DDD). Methods Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and randomly assigned to one of two treatment groups: 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System (Medtronic Sofamor Danek); 265 patients in the control group underwent decompressive ACDF. Eighty percent of the arthroplasty-treated patients (223 of 276) and 75% of the control patients (198 of 265) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery. Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group. The arthroplasty group also had a statistically significant higher rate of neurological success (p = 0.005) as well as a lower rate of secondary revision surgeries (p = 0.0277) and supplemental fixation (p = 0.0031). The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months, as was relief of neck pain. The patients in the investigational group returned to work 16 days sooner than those in the control group, and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well (p = 0.0492, log-rank test). The cervical disc implant maintained segmental sagittal angular motion averaging more than 7°. In the investigational group, there were no cases of implant failure or migration. Conclusions The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success, improved clinical outcomes, and a reduced rate of secondary surgeries compared with ACDF.

scholarly journals Cervical disc prosthesis: 2-year follow-up

2015 ◽  
Vol 14 (2) ◽  
pp. 85-87
Author(s):  
Romero Pinto de Oliveira Bilhar ◽  
Alexandre Fogaça Cristante ◽  
Raphael Martus Marcon ◽  
Ivan Dias da Rocha ◽  
Olavo Biraghi Letaif ◽  
...  
Keyword(s):  
Medical Records ◽  
Epidemiological Data ◽  
Cervical Disc ◽  
Safe Procedure ◽  
Disc Prosthesis ◽  
Cervical Arthroplasty ◽  
Cervical Disc Prosthesis ◽  
The Mean

<sec><title>OBJECTIVE:</title><p> To review the medical records of patients who underwent surgery for placement of cervical disc prosthesis after two years of postoperative follow-up, showing the basic epidemiological data, the technical aspects and the incidence of complications.</p></sec><sec><title>METHODS:</title><p> Medical records of seven patients who underwent surgery for placement of cervical disc prosthesis were reviewed after two years of follow-up, at the Institute of Orthopedics and Traumatology, Faculty of Medicine, University of São Paulo.</p></sec><sec><title>RESULTS:</title><p> The average age of patients participating in this study was 43.86 years. Six patients (85.7%) had one level approached while one patient (14.3%) had two levels addressed. The level C5-C6 has been approached in one patient (14.3%) while the C6-C7 level was addressed in five patients (71.4%). One patient (14.3%) had these two levels being addressed, C5-C6 and C6-C7. The mean operative time was 164.29±40 minutes. Three patients were hospitalized for 2 days and four for 3 days making an average of 2.57±0.535 days. Two patients (28.6%) underwent a new surgical intervention due to loosening of the prosthesis. The mean follow-up was 28.14±5.178 months (23-35 months).</p></sec><sec><title>CONCLUSIONS:</title><p> Although cervical arthroplasty appears to be a safe procedure and present promising results in our study as well as in many other studies, it requires long-term studies.</p></sec>

Prospective long-term longitudinal radiographic follow-up after treatment of cervical disc disease with the Bryan cervical disc prosthesis

2009 ◽  
Vol 72 (5) ◽  
pp. 515
Author(s):  
J. Walraevens ◽  
J. Vander Sloten ◽  
P. Demaerel ◽  
P. Suetens ◽  
J. van Loon ◽  
...  
Keyword(s):  
Cervical Disc ◽  
Disc Prosthesis ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Cervical Disc Prosthesis

scholarly journals Effects of a cervical disc prosthesis on segmental and cervical spine alignment

2004 ◽  
Vol 17 (3) ◽  
pp. 1-35 ◽  
Author(s):  
Gwynedd E. Pickett ◽  
Demytra K. Mitsis ◽  
Lali H. Sekhon ◽  
William R. Sears ◽  
Neil Duggal
Keyword(s):  
Cervical Spine ◽  
Clinical Outcomes ◽  
Sagittal Balance ◽  
Cervical Disc ◽  
Disc Prosthesis ◽  
Disc Space ◽  
Cervical Arthroplasty ◽  
Sf 36 ◽  
Cervical Disc Prosthesis

Object Cervical arthroplasty offers the promise of maintaining motion of the functional spinal unit (FSU) after anterior cervical discectomy. The impact of cervical arthroplasty on sagittal alignment of the FSU needs to be addressed, together with its effect on overall sagittal balance of the cervical spine. Methods The authors prospectively reviewed radiographic and clinical outcomes in 14 patients who received the Bryan Cervical Disc prosthesis (Medtronic Sofamor Danek, Memphis, TN), for whom early (< 6 months) and late (6–24 months) follow-up data were available. Static and dynamic radiographs were measured by hand and computer to determine the angles formed by the endplates of the natural disc preoperatively, those formed by the shells of the implanted prosthesis, the angle of the FSU, and the C2–7 Cobb angle. The range of motion (ROM) was also determined radiographically, whereas clinical outcomes were assessed using the Neck Disability Index (NDI), and Short Form–36 (SF-36) questionnaires. The ROM was preserved following surgery, with a mean preoperative sagittal rotation angle of 8.96°, which was not significantly different from the late postoperative value of 8.25°. When compared with the preoperative disc space angle, the shell endplate angle in the neutral position became kyphotic in the early and late postoperative periods (mean change −3.8° in the late follow-up period; p = 0.0035). The FSU angles also became significantly more kyphotic post-operatively, with a mean change of −6° (p = 0.0006). The Cobb angles varied widely preoperatively and did not change significantly after surgery. There was no statistical correlation between the NDI and SF-36 outcomes and cervical kyphosis. Conclusions Cervical arthroplasty preserves motion of the FSU. Both the endplate angle of the treated disc space and the angle of the FSU became kyphotic after insertion of the Bryan prosthesis. The overall sagittal balance of the cervical spine, however, was preserved.

scholarly journals Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial

2017 ◽  
Vol 27 (1) ◽  
pp. 7-19 ◽  
Author(s):  
Todd H. Lanman ◽  
J. Kenneth Burkus ◽  
Randall G. Dryer ◽  
Matthew F. Gornet ◽  
Jeffrey McConnell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Surgical Procedure ◽  
Disc Replacement ◽  
Cervical Disc ◽  
Segmental Motion ◽  
Randomized Controlled ◽  
Low Profile ◽  
The Prestige

OBJECTIVEThe aim of this study was to assess long-term clinical safety and effectiveness in patients undergoing anterior cervical surgery using the Prestige LP artificial disc replacement (ADR) prosthesis to treat degenerative cervical spine disease at 2 adjacent levels compared with anterior cervical discectomy and fusion (ACDF).METHODSA prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted at 30 US centers, comparing the low-profile titanium ceramic composite-based Prestige LP ADR (n = 209) at 2 levels with ACDF (n = 188). Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative intervals to 84 months. The primary end point was overall success, a composite variable that included key safety and efficacy considerations.RESULTSAt 84 months, the Prestige LP ADR demonstrated statistical superiority over fusion for overall success (observed rate 78.6% vs 62.7%; posterior probability of superiority [PPS] = 99.8%), Neck Disability Index success (87.0% vs 75.6%; PPS = 99.3%), and neurological success (91.6% vs 82.1%; PPS = 99.0%). All other study effectiveness measures were at least noninferior for ADR compared with ACDF. There was no statistically significant difference in the overall rate of implant-related or implant/surgical procedure–related adverse events up to 84 months (26.6% and 27.7%, respectively). However, the Prestige LP group had fewer serious (Grade 3 or 4) implant- or implant/surgical procedure–related adverse events (3.2% vs 7.2%, log hazard ratio [LHR] and 95% Bayesian credible interval [95% BCI] −1.19 [−2.29 to −0.15]). Patients in the Prestige LP group also underwent statistically significantly fewer second surgical procedures at the index levels (4.2%) than the fusion group (14.7%) (LHR −1.29 [95% BCI −2.12 to −0.46]). Angular range of motion at superior- and inferior-treated levels on average was maintained in the Prestige LP ADR group to 84 months.CONCLUSIONSThe low-profile artificial cervical disc in this study, Prestige LP, implanted at 2 adjacent levels, maintains improved clinical outcomes and segmental motion 84 months after surgery and is a safe and effective alternative to fusion.Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)

Long-Term Follow-Up of Early Cochlear Implant Device Activation

2021 ◽  
pp. 1-11
Author(s):  
Stefanie Bruschke ◽  
Uwe Baumann ◽  
Timo Stöver
Keyword(s):  
Speech Recognition ◽  
Side Effects ◽  
Cochlear Implant ◽  
Surgical Techniques ◽  
Control Group ◽  
First Year ◽  
Safe Procedure ◽  
Sound Processor

Background: The cochlear implant (CI) is a standard procedure for the treatment of patients with severe to profound hearing loss. In the past, a standard healing period of 3–6 weeks occurred after CI surgery before the sound processor was initially activated. Advancements of surgical techniques and instruments allow an earlier initial activation of the processor within 14 days after surgery. Objective: Evaluation of the early CI device activation after CI surgery within 14 days, comparison to the first activation after 4–6 weeks, and assessment of the feasibility and safety of the early fitting over a 12 month observation period were the objectives of this study. Method: In a prospective study, 127 patients scheduled for CI surgery were divided into early fitting group (EF, n = 67) and control group (CG, n = 60). Individual questionnaires were used to evaluate medical and technical outcomes of the EF. Medical side effects, speech recognition, and follow-up effort were compared with the CG within the first year after CI surgery. Results: The early fitting was feasible in 97% of the EF patients. In the EF, the processor was activated 25 days earlier than in the CG. No major complications were observed in either group. At the follow-up appointments, side effects such as pain and balance problems occurred with comparable frequency in both groups. At initial fitting, the EF showed a significantly higher incidence of medical minor complications (p < 0.05). When developing speech recognition within the first year of CI use, no difference was observed. Furthermore, the follow-up effort within the first year after CI surgery was comparable in both groups. Conclusions: Early fitting of the sound processor is a feasible and safe procedure with comparable follow-up effort. Although more early minor complications were observed in the EF, there were no long-term wound healing problems caused by the early fitting. Regular inspection of the magnet strength is recommended as part of the CI follow-up since postoperative wound swelling must be expected. The early fitting procedure enabled a clear reduction in the waiting time between CI surgery and initial sound processor activation.

scholarly journals Lichtenstein inguinal hernia repairs with porcine small intestine submucosa: a 5- year follow-up. a prospective randomized controlled study

2021 ◽  
Author(s):  
Baoshan Li ◽  
Xin Zhang ◽  
Yi Man ◽  
Jiadong Xie ◽  
Wei Hu ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Inguinal Hernia ◽  
Hernia Repair ◽  
Term Effect ◽  
Control Group ◽  
Small Intestine Submucosa ◽  
Long Term Effect ◽  
Porcine Small Intestine Submucosa

Abstract Porcine small intestine submucosa (SIS) biologic patch has been used in inguinal hernia repair. However, there are little data available to assess the long-term effect after repair. This study aimed to explore the long-term effect of SIS patch in open inguinal hernia repair. Sevent-six patients with unilateral inguinal hernia were treated with Lichtenstein tension-free hernia repair using SIS patch (Beijing Datsing Bio-Tech Co., Ltd.) and Surgisis patch (COOK, USA) in Tianjin Union Medical Center and China-Japan Friendship Hospital. In the trial, the long-term efficacy of the treatment group and the control group were compared. A total of 66 patients in both groups received long-term follow-up (&gt; 5 years) after surgery, with a follow-up rate of 86.8%. During the follow-up period, there was one case of recurrence, one case of chronic pain in the control group. There was no statistically significant difference (P &gt; 0.05) in terms of recurrence, chronic pain, foreign body sensation and infection between the two groups of patients. After long-term observations, it has been found that the porcine small intestinal submucosa (SIS) biological patch is safe and effective for inguinal hernia Lichtenstein repair, and has a low recurrence rate and complication rate.

scholarly journals Role and effectiveness of complex and supervised rehabilitation on overall and hand function in systemic sclerosis patients—one-year follow-up study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Michał Waszczykowski ◽  
Bożena Dziankowska-Bartkowiak ◽  
Michał Podgórski ◽  
Jarosław Fabiś ◽  
Arleta Waszczykowska
Keyword(s):  
Systemic Sclerosis ◽  
Hand Function ◽  
Exercise Program ◽  
Rehabilitation Program ◽  
Long Term Results ◽  
Home Exercise ◽  
Control Group ◽  
Study Group

AbstractThe aim of this study was to estimate the long-term results of complex and supervised rehabilitation of the hands in systemic sclerosis (SSc) patients. Fifty-one patients were enrolled in this study: 27 patients (study group) were treated with a 4-week complex, supervised rehabilitation protocol. The control group of 24 patients was prescribed a home exercise program alone. Both groups were evaluated at baseline and after 1-, 3-, 6-, and 12-months of follow-up with the Disability of the Arm, Shoulder and Hand Questionnaire (DAHS) as the primary outcome, pain (VAS—visual analog scale), Cochin Hand Function Scale (CHFS), Health Assessment Questionnaire Disability Index (HAQ-DI), Scleroderma-HAQ (SHAQ), range of motion (d-FTP—delta finger to palm, Kapandji finger opposition test) and hand grip and pinch as the secondary outcomes. Only the study group showed significant improvements in the DASH, VAS, CHFS and SHAQ after 1, 3 and 6 months of follow-up (P = 0.0001). Additionally, moderate correlations between the DASH, CHFS and SHAQ (R = 0.7203; R = 0.6788; P = 0.0001) were found. Complex, supervised rehabilitation improves hand and overall function in SSc patients up to 6 months after the treatment but not in the long term. The regular repetition of this rehabilitation program should be recommended every 3–6 months to maintain better hand and overall function.

Sign in / Sign up

Export Citation Format

Share Document