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Biomedical subjects

Ronald H M A Bartels

Publications and source records attributed to Ronald H M A Bartels.

16 recordsLinked to original sources
PubMed2006

Design of the PROCON trial: a prospective, randomized multi-center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty.

BACKGROUND: PROCON was designed to assess the clinical outcome, development of adjacent disc disease and costs of cervical anterior discectomy without fusion, with fusion using a stand alone cage and implantation of a Bryan's disc prosthesis. Description of rationale and design of PROCON trial and discussion of its strengths and limitations. METHODS/DESIGN: Since proof justifying the use of implants or arthroplasty after cervical anterior discectomy is lacking, PROCON was designed. PROCON is a multicenter, randomized controlled trial comparing cervical anterior discectomy without fusion, with fusion with a stand alone cage or with implantation of a disc. The study population will be enrolled from patients with a single level cervical disc disease without myelopathic signs. Each treatment arm will need 90 patients. The patients will be followed for a minimum of five years, with visits scheduled at 6 weeks, 3 months, 12 months, and then yearly. At one year postoperatively, clinical outcome and self reported outcomes will be evaluated. At five years, the development of adjacent disc disease will be investigated. DISCUSSION: The results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective.

Adolescent↗
PubMed2006

Subsidence of stand-alone cervical carbon fiber cages.

OBJECTIVE: To investigate the number of subsidences of inserted cervical carbon fiber cages and to define predictive factors for subsidence. METHODS: All patients treated for a cervical herniated disc and fusion with a cervical carbon fiber cage between January 2002 and December 2003 were retrospectively identified. The radiological examinations were reviewed, and, especially, the presence of subsidence was noted. Possible predictive factors for subsidence were determined before the investigation. RESULTS: In 69 patients, there were 96 cages inserted, of which 29.2% subsided. Of all factors investigated, only smoking seemed to be predictive for subsidence, whereas insertion at C6 to C7 clearly had a higher risk at subsidence. Subsidence was not related to outcome or fusion. CONCLUSION: Although the high number of subsidence of cages has never been described before, clinical outcome and fusion rate is comparable with the literature.

Adult↗
PubMed2005

Single-blinded prospective randomized study comparing open versus needle technique for obtaining autologous cancellous bone from the iliac crest.

One of the most frequent complications of cervical anterior discectomy with fusion is pain at the donor site, usually the iliac crest. Despite the advent of new materials, autologous bone is still the "gold standard" for fusion procedures. A prospective, single blinded, randomized study was performed to evaluate the effect of a minimal invasive technique to obtain autologous bone from the iliac crest on pain. The minimal invasive technique uses a large needle to obtain cancellous bone. Consecutive patients scheduled for cervical anterior discectomy with a fusion using a cage were randomly assigned either to the classical open group or the needle group. Patients were unaware of the two possible options for obtaining autologous bone. They were asked to fill in visual analogue scores (VASs) at fixed moments during the first 6 weeks postoperatively. Three VASs were recorded: the score at the moment, the minimal score and the maximal score during the last 24 h. The wound at the iliac crest was measured 6 weeks postoperatively. Complications were registered. Fifty patients were enrolled. Twenty-five patients were assigned to each group . The pain scores from the needle group were significantly less than from the open group. At 2 weeks postoperatively, nearly all patients (88%) of the needle group were free of pain at the iliac crest, whereas ten patients (40%) of the open group still had some pain. Complications only occurred in the open group. Six patients complained of diminished sensibility. In two cases, it had resolved at 6 weeks postoperatively. In one case, a hemorrhage occurred. Surgical evacuation was not necessary. Obtaining autologous cancellous bone through a large needle for filling a cervical cage (even multiple cages) is safe and evidently less painful than through a classical open procedure. If pain exists it does not last very long. Generally, the pain is resolved within 2 weeks.

Adult↗
PubMed2005

Prospective randomized controlled study comparing simple decompression versus anterior subcutaneous transposition for idiopathic neuropathy of the ulnar nerve at the elbow: Part 1.

OBJECTIVE: The main objective of this study was to compare the clinical outcome of participants treated by simple decompression (SD) of the ulnar nerve versus anterior subcutaneous transposition (AST). METHODS: A prospective randomized controlled study was performed. Three hundred forty participants were referred to our institution between March 1999 and July 2002. One hundred fifty-two patients met the inclusion criteria and were randomized into two surgical groups: 75 were assigned to SD, and 77 were assigned to AST. Participants were followed for 1 year after surgery. The main outcome measure was clinical outcome 1 year after surgery. RESULTS: An excellent or good result was obtained in 49 of 75 participants who underwent SD and in 54 of 77 participants undergoing AST. The difference was not statistically significant. However, the complication rate was statistically lower in the SD group (9.6%) compared with the AST group (31.1%) (risk ratio, 0.32; 95% confidence interval, 0.14-0.69). Duration of symptoms, (sub)luxation of the ulnar nerve, and severity of the complaints did not influence outcome. CONCLUSION: Surgery for ulnar neuropathy at the elbow is effective. The outcomes of SD and AST are equivalent, except for the complication rate. Because the intervention is simpler and associated with fewer complications, SD is advised, even in the presence of (sub)luxation.

Adult↗
PubMed2005

Fusion around cervical disc prosthesis: case report.

OBJECTIVE AND IMPORTANCE: Cervical arthroplasty is a relatively new method to maintain motion after cervical anterior discectomy. Two cases are presented in which bony fusion occurred around a cervical disc prosthesis. CLINICAL PRESENTATION: A 30-year-old man and a 49-year-old woman underwent a right-sided anterior cervical discectomy because of pain in the right arm resulting from a herniated disc (C5-C6). INTERVENTION: A cervical disc prosthesis (Bryan disc prosthesis) was implanted. Postoperatively, the patients were completely free of pain. At the regular 1- and 2-year follow-up examinations, bony fusion was seen on plain x-rays of the cervical spine. The patients were still completely free of signs and symptoms. CONCLUSION: This is the first report in the literature of bony fusion after cervical arthroplasty with the Bryan disc prosthesis.

Adult↗
PubMed2005

Use of a novel absorbable hydrogel for augmentation of dural repair: results of a preliminary clinical study.

OBJECTIVE: To evaluate the safety and performance of a synthetic dural sealant as an adjunct to standard surgical dural repair techniques to prevent cerebrospinal fluid (CSF) leakage. METHODS: This study was designed as a prospective, nonrandomized, single-center clinical trial. The dural sealant is a synthetic absorbable hydrogel. Consecutive series of patients scheduled for elective cranial and intradural spinal surgery were included until a total of 50 applications were achieved. It was used primarily as an adjunct to ensure watertight dural closure. The end point was defined as no leak with the Valsalva maneuver after dural sealant application. The patients were followed up for 3 months after surgery to check for CSF leakage, standard laboratory and neurological examinations, and possible adverse advents. RESULTS: Of the 49 patients, 46 were included and treated with the dural sealant because of spontaneous leak (n = 34; 69%) or leak after the Valsalva maneuver (n = 12; 25%). There was no leak in the other patients (n = 3; 6%). After application of the dural sealant, there was no leak in all 46 patients (100%). Of the 46 patients included, there was one case of overt CSF leak. One patient had a pseudomeningocele. There were no adverse events other than those related to the disease or to the surgical procedure itself. CONCLUSION: The dural sealant, a synthetic absorbable hydrogel, is a useful adjunct to achieve watertight dural closure. Application resulted in 100% closure of intraoperative CSF leaks. There are no evident adverse effects.

Absorbable Implants↗
PubMed2005

Simple decompression or anterior subcutaneous transposition for ulnar neuropathy at the elbow: a cost-minimization analysis--Part 2.

OBJECTIVE: A randomized controlled trial was reported recently, in which simple decompression and anterior subcutaneous transposition were compared for treatment of ulnaropathy at the elbow. Clinically, both surgical options seem to be equally effective. The objective of this study is to compare the costs, from a societal standpoint, of simple decompression versus anterior subcutaneous transposition in Euros. METHODS: Published and unpublished data from a randomized controlled trial that compared simple decompression and anterior subcutaneous transposition were used. The investigators tabulated the actual costs incurred for professional fees, use of the operating room, duration of sick leave, reintervention, and treatment of complications directly related to the surgical treatment. RESULTS: The total costs per group and per patient were statistically significantly less for those treated with simple decompression. The total median costs per patient were 1124 Euros for simple decompression and 2730 Euros for anterior subcutaneous transposition. The main difference was in the costs related to sick leave, which is significantly shorter for simple decompression. There also was a statistically significant difference in operation time in favor of simple decompression. A remarkable finding was that paid workers in both treatment groups returned to work much later than unpaid workers. CONCLUSION: Although clinically equally effective, simple decompression was associated with lower cost than anterior subcutaneous transposition for the treatment of ulnar neuropathy at the elbow. Compared with anterior subcutaneous transposition, we recommend simple decompression for the treatment of idiopathic ulnar neuropathy at the elbow.

Absenteeism↗
PubMed2005

Anterior cervical interbody fusion with radiolucent carbon fiber cages: clinical and radiological results.

The authors retrospectively evaluated 30 patients with an anterior cervical interbody fusion for cervical spondylosis or disc herniation. Open box carbon fiber cages were used at 45 levels. The visual analogue scales (VAS), respectively for neck and for arm pain, and the neck disability index (NDI) improved significantly (p < 0.001). Fusion occurred in 87% of the operated levels. Subsidence of the cages into the endplates was observed in 49% of the operated levels, which increased to 54% when more levels were fused. No correlation between subsidence of the cage and clinical outcome or radiographic fusion was established. The authors conclude that cervical discectomy and interbody fusion using an open box carbon fiber cage is a satisfactory treatment option for degenerative cervical disease causing neck pain and radiculopathy, despite the relatively high percentage of subsidence of this cage.

Adult↗
PubMed2004

Skin closure in carpal tunnel surgery: a prospective comparative study between nylon, polyglactin 910 and stainless steel sutures.

OBJECTIVE: To compare the cosmetic outcome, pain and tenderness around the operation scar of carpal tunnel syndrome surgery using either nylon, polyglactin 910 or stainless steel sutures for skin closure. METHODS: A randomised clinical trial comparing nylon, polyglactin 910 or stainless steel sutures for skin closure in 61 patients undergoing carpal tunnel syndrome surgery was performed. Pain, tenderness, scar hypertrophy, redness and the presence of granulomas were assessed in all patients at ten days and six weeks after surgery and compared by non-parametric statistical tests. RESULTS: Adequate surgical decompression of the median nerve could be achieved in all patients. All but two patients experienced significant relief of tingling of the fingers. Nearly all patients reported some degree of discomfort around the scar. At ten days, the mean pain score was 1.7 (+/-2.2), 3.1 (+/-2.3) and 1.9 (+/-2.3) for the nylon, vicryl and steel groups, respectively. At six weeks, the pain score was 3.6 (+/-3.1), 3.4 (+/-2.6) and 2.7 (+/-2.1) for the nylon, vicryl and steel groups, respectively. The infection rate was 0%, 8% and 0% for the nylon, vicryl and steel groups, respectively. Suture granulomas were significantly more present in the vicryl group (p<0.05). There were no statistical differences in redness or hypertrophy of the wound between the three groups. CONCLUSIONS: Nylon and stainless steel sutures are both suitable for skin closure after carpal tunnel surgery. Based on this study, absorbable vicryl sutures should not be used, since the incidence of infections and the presence of suture granulomas was much higher than in the nylon and steel suture groups.

Adult↗
PubMed2002

Aneurysm of the anterior inferior cerebellar artery (AICA) associated with high-flow lesion: report of two cases and review of literature.

OBJECTIVE AND IMPORTANCE: Although aneurysms of the anterior inferior cerebellar artery (AICA) are rare lesions, their occurrence in combination with high-flow lesions in the same arterial territory is even more striking. Two cases of an AICA aneurysm in combination with a high -flow lesion are described. CLINICAL PRESENTATION: In one case, a 52-year-old female presented with cerebellar syndrome as the result of a left-sided cerebellar tumor. Angiography revealed a highly vascularized tumor and a broad-based aneurysm at the offspring of the left AICA. In the second case, a 17-year-old female presented with a right-sided cerebellar hemorrhage. Angiography revealed a large peripheral AICA aneurysm and a distal arteriovenous malformation (AVM) fed by the AICA. INTERVENTION: In the first case, a left lateral suboccipital craniotomy was performed and a highly vascularized tumor was removed. The AICA aneurysm could not be adequately clipped and was subsequently wrapped with muscle and reinforced with fibrin glue. Pathological examination of the tumor revealed a hemangioblastoma. Five years after surgery, the patient experienced a subarachnoid hemorrhage. Subsequent vertebral angiography revealed local enlargement of the known AICA aneurysm just at the superior aspect, but the patient refused further treatment. In the second case, the patient sustained a novel cerebellar rebleed while awaiting surgery. A right-sided lateral retromastoid suboccipital craniotomy was performed and the AICA aneurysm could be successfully clipped. More peripherally, the AVM with two draining veins could be totally removed. Postoperative angiography revealed no residual aneurysm or AVM. CONCLUSION: Several aspects of these cases are discussed, such as the rare occurrence of AICA aneurysm and the contribution of high-flow lesions to the genesis of the AICA aneurysms.

Adolescent↗
PubMed2002

Delayed management of traumatic bilateral cervical facet dislocation: surgical strategy. Report of three cases.

Postinjury cervical spine instability typically requires surgical treatment in the acute or semiacute stage. The authors, however, report on three patients with older (> 8 weeks) untreated bilateral cervical facet dislocation. In two patients they attempted a classic anterior-posterior-anterior approach but failed. The misalignment in the second stage of the procedure could not be corrected, and they had to add a fourth, posterior, stage. To avoid the fourth stage, thereby reducing operating time and risk of neurological damage while turning the patient, they propose the following sequence: 1) a posterior approach to perform a complete facetectomy bilaterally with no attempt to reduce the dislocation; 2) an anterior microscopic discectomy with reduction of the dislocation and anterior fixation; and 3) posterior fixation. This sequence of procedures was successfully performed in the third patient. Based on this experience, they suggest that in cases of nonacute bilateral cervical facet dislocations the operating sequence should be posterior-anterior-posterior.

Aged↗