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Thread: Welcome to the Trials Forum

  1. #1

    Welcome to the Trials Forum

    In this forum, the moderator must approve a new topic before it is displayed. This ensures that each topic represents a clinical trial or a specific topic relating to clinical trials. The moderator will also be editing and updating the lead descriptor a ssociated with each topic. If you would like a particular clinical trial covered here, please post them here and I will get the topic going. You can also initiate the topic and enter the relevant information. But, to ensure that the topics are not duplicative, they will not show until I approve them. Please note that the initial message on the topic should describe the trial and the current status, including valid web links if possible. Thanks. Everybody of course can post their questions and views within each topic. Please note that you can request a digest of new postings to each of these topics sent to you via email. Wise.

    [This message was edited by Wise Young on July 30, 2001 at 09:47 AM.]

  2. #2
    Senior Member rdf's Avatar
    Join Date
    Jul 2001
    Someplace between Nowhere and Goodbye

    Great forum!

    Super idea, Wise. Having such a helpful, informative repository as this will surely grow to be, is a great resource for everybody with sci, their friends, and loved ones. It will also serve the medical profession well. Thanks

  3. #3
    I am beginning to post a variety of clinical trials, using three criteria for choosing the trials to include.

    1. The trial is recruiting subjects with spinal cord injury.

    2. The trial involves a therapy that animal studies have suggested to be beneficial in spinal cord injury, even though the trial may not be recruiting subjects with spinal cord injury.

    3. The trial has been announced and has not yet started but, in my judgement, will be initiated within a year. I am holding back on some trials that have been announced or rumored to start for over a year.

    The number of trials involving spinal cord injury have been increasing and this represents the most comprehensive listing on Internet that I am aware of.

    Please, if anybody has additional information or questions concerning any of the clinical trials, please post the information or question here.


  4. #4
    Senior Member Rick1's Avatar
    Join Date
    Jul 2001
    Carlsbad, CA


    Dr. Young - Can you bring us up to date on Dr. Hellerqvist and CM-101? Thank you.

  5. #5
    Senior Member glomae's Avatar
    Join Date
    Jul 2001

    wise young

    dr young has anyone told you lately how greaaat you are, your compassion is so so so appreciated your the best. THANKS, GLORIA

  6. #6

    Dr Henry Bohlman

    Dr Young, I am curious to know if Dr Bohlman or others have done any trials with regard to decompression of the spinal cord? Has anyone in the US pursued decompression as a treatment alternative? I asked Dr Donovan about it at TIRR this last week and he suggested that he had never heard of it being done without the patient being in a position of loosing function. He seemed to think it was too risky to be tried for any other purpose.

    *As I was asking him questions regarding research, he dismissed most with a chuckle. But, he did take notice when I mentioned Dr Raisner and said "he's doing some amazing things, it's very interesting".

  7. #7

    Hank Bohlman decompression results

    Carl R,

    Perhaps Dr. Donovan misunderstood your question and was speaking from his own experience. One of the problems with the current approach towards operative management of chronic spinal cord injury is that it is a self-fulfilling prophesy for two reasons. First, because the doctor believes that chronic decompression will not be useful for restoring function, the operation is applied to only patients who are deteriorating (from a syrinx, etc.), Most of these patients are losing function and the surgeons are simply satisfied to stop the progressive loss. Second, very few of the surgeons follow the patients for more than 2 years. In contrast, Hank Bohlman frequently will follow the patients for 10 years before he reports on the results of his surgery.

    Hank Bohlman's first reports of improvement with decompression were published over 10 years ago. Anyway, here are so some of his studies. Please note that some of these surgeries (particularly in the 1992 papers) were done in the 1980's when surgical instrumentation and techniques are not as good as they are today. Please remember also the atmosphere of the time when no surgeon would have dared even suggest that anybody with a "complete" spinal cord injury could recover anything. In 1990's, our methylprednisolone study allowed doctors to say things like that because our study showed that the drug improves recovery in people with so-called "complete" spinal cord injury.

    By the way, I also want to point out the surgical decompression is not a miraculous therapy. When I first heard these results, i.e. that some patients showed functional improvement when decompressed as long as 5-10 years after injury, some of the cases were amazing. Can you imagine... the spinal cords that he operated on had been compressed and non-functional for years. He saw his patients getting back significant return of function after surgical decompression. If you had been sitting on a single spot on your butt for a couple of years and a pressure sore developed, would you expect recovery by simply taking the pressure off?

    I have shared the podium with Hank Bohlman several times in the last couple of years and he has a wonderful talk in which he summarizes his lifetime experience decompressing chronic spinal cord injury. I don't think that he has published a summary of all that. It was after having heard that talk that I am convinced that chronic decompression really can restore function in a significant minority of people with chronic spinal cord injury. I list the abstracts of some of his papers below.


    • Bohlman HH and Anderson PA (1992). Anterior decompression and arthrodesis of the cervical spine: long-term motor improvement. Part I--Improvement in incomplete traumatic quadriparesis. J Bone Joint Surg Am. 74 (5): 671-82. Summary: Between 1973 and 1983, fifty-eight patients who had an incomplete spinal-cord injury secondary to a fracture or dislocation of the cervical spine were managed by anterior cervical decompression and arthrodesis with iliac bone grafts. In all patients, myelography showed that displaced fragments of bone or disc were compressing the anterior aspect of the spinal cord. Anterior decompression was performed in an attempt to improve function in the upper and lower extremities. The average interval from the injury to the decompression was thirteen months (range, one month to nine years). Two patients died of cardiopulmonary disease within two months after the operation, and one patient died eighteen months after the operation. The remaining fifty- five patients were followed for an average of six years (range, two to seventeen years). Twenty-nine patients became functional ambulators after the operation. An additional six patients who could walk before the operation had improvement in the ability to walk. Noteworthy improvement in motor-root function in the upper extremities was seen in thirty-nine patients. Only nine patients had no signs of improvement of motor function. Improvement was less in the patients in whom operative decompression had been done more than twelve months after the injury. The patients who had an extension injury to a spondylotic spine were older, and fewer of them had improvement. No patient lost neurological function as a result of the operation. Anterior decompression and arthrodesis, even when performed late after the injury, can improve neurological function in both the upper and lower extremities in many patients who have incomplete quadriplegia due to a fracture or dislocation of the cervical spine. <> Acute Spinal Cord Injury Services, Veterans Administration Medical Center, Cleveland, Ohio.

    • Anderson PA and Bohlman HH (1992). Anterior decompression and arthrodesis of the cervical spine: long-term motor improvement. Part II--Improvement in complete traumatic quadriplegia. J Bone Joint Surg Am. 74 (5): 683-92. Summary: Fifty-one patients who had complete motor quadriplegia secondary to a fracture or dislocation of the cervical spine were managed by anterior cervical decompression and arthrodesis with iliac bone grafts between 1973 and 1983. In all patients, myelography demonstrated that displaced fragments of bone and disc were compressing the anterior aspect of the spinal cord. Decompression was performed in an attempt to gain further improvement of the motor-roots in the upper extremities and thereby to improve the ability of the patients to care for themselves. The average interval from the injury to the decompression was fifteen months (range, one month to eight years). Two patients died within two months after the operation, one had a respiratory arrest that resulted in brain damage one day after the operation, and two died from cardiovascular disease more than one year after the operation. The remaining forty-six patients were followed for an average of five years (range, two to thirteen years). Neurological improvement of at least two new functional motor-root levels was documented in seven patients and of one level, in eighteen. Increased motor strength by two or three grades was seen in six patients. Noteworthy motor improvement did not occur in the remaining twenty patients. The mean modified Barthel index (used to measure improvement in the ability to perform activities of daily living) increased from 17 to 33 (of a possible 100) points. Functionally important improvement of the caudad part of the cord occurred in only one patient. In one patient, neural injury, with loss of one motor-root level, occurred, with only partial improvement. At the latest follow-up examination, the result was poor in nine of eleven patients who had decompression eighteen months or more after the injury. Only two of these patients had any improvement in the Barthel index, and then of only 5 points each. The result also was poor in the five patients who were more than fifty-three years old; two had no improvement in the Barthel index, one improved by 5 points, and two died. <> Acute Spinal Cord Injury Services, Veterans Administration Medical Center, Cleveland, Ohio.

    • Bohlman HH, Kirkpatrick JS, Delamarter RB and Leventhal M (1994). Anterior decompression for late pain and paralysis after fractures of the thoracolumbar spine. Clin Orthop. (300): 24-9. Summary: Anterior decompression of the thoracic and lumbar spine is indicated for patients with trauma, infection, or tumor that causes compression of the neural tissues, resulting in an incomplete neurologic deficit. The complication of chronic pain, with or without paralysis, that results from fractures with canal compromise has received little attention. This study involved 45 patients who had anterior decompression for chronic pain or paralysis at an average of 4.5 years after having thoracolumbar fractures. Pain was improved in 41 of 45 patients, with complete relief in 30 and partial relief in 11. In 25 patients with neurologic deficit, 21 noted improvement, 14 of which improved one or more grades of the Eismont classification. No patient had an increase in pain or loss of neurologic function. Complications were few. Anterior decompression of the thoracolumbar spine for chronic pain after thoracolumbar fractures is a safe and effective treatment for patients with this uncommon and difficult problem. <> Reconstructive and Traumatic Spine Surgery Center, University Hospital, Cleveland, Ohio.

    • Emery SE, Bohlman HH, Bolesta MJ and Jones PK (1998). Anterior cervical decompression and arthrodesis for the treatment of cervical spondylotic myelopathy. Two to seventeen-year follow-up. J Bone Joint Surg Am. 80 (7): 941-51. Summary: We reviewed the cases of 108 patients with cervical spondylotic myelopathy who had been managed with anterior decompression and arthrodesis at our institution. Operative treatment consisted of anterior discectomy, partial corpectomy, or subtotal corpectomy at one level or more, followed by placement of autogenous bone graft from the iliac crest or the fibula. At the latest follow-up examination, thirty- eight of the eighty-two patients who had had a preoperative gait abnormality had a normal gait, thirty-three had an improvement in gait, six had no change, four had improvement and later deterioration, and one had a worse gait abnormality. Of the eighty-seven patients who had had a preoperative motor deficit, fifty-four had complete recovery; twenty-six, partial recovery; six, no change; and one had a worse deficit. The average grade according to the system of Nurick improved from 2.4 preoperatively to 1.2 (range, 0.0 to 5.0) postoperatively. A pseudarthrosis developed in sixteen patients, thirteen of whom had had a multilevel discectomy. Only one of thirty-eight arthrodeses that had been performed with use of a fibular strut graft was followed by a non- union. An unsatisfactory outcome with respect to pain was significantly associated with pseudarthrosis (p < 0.001). The development of complications other than non-union was associated with a history of one previous operative procedure or more [p = 0.005). Recurrent myelopathy was rare, but when it occurred it was associated with a pseudarthrosis or stenosis at a new level. The strongest predictive factor for recovery from myelopathy was the severity of the myelopathy before the operative intervention--that is, better preoperative neurological function was associated with a better neurological outcome. Anterior decompression and arthrodesis with autogenous bone-grafting can be performed safely, and is associated with a high rate of neurological recovery, functional improvement, and pain relief, in patients who have cervical spondylotic myelopathy. <> Department of Orthopaedic Surgery, University Hospitals Spine Institute, Case Western Reserve University School of Medicine, Cleveland, Ohio 44106, USA.

    • McAfee PC, Bohlman HH, Ducker TB, Zeidman SM and Goldstein JA (1995). One-stage anterior cervical decompression and posterior stabilization. A study of one hundred patients with a minimum of two years of follow- up. J Bone Joint Surg Am. 77 (12): 1791-800. Summary: One hundred patients were managed with one-stage anterior decompression and posterior stabilization of the cervical spine. The underlying indication for the operation was cervical trauma in thirty-one patients; a neoplasm with a pathological fracture or an incomplete neurological deficit in fifty-five; and a miscellaneous condition, such as infection, rheumatoid arthritis, or cervical spondylotic myelopathy, in fourteen. The duration of follow-up ranged from twenty-four to 108 months (mean, thirty-two months) for the living patients. Sixteen patients had the procedure after the failure of an operation that had been performed elsewhere. The development of more biomechanically rigid cervical instrumentation did not obviate the need for a combined anterior and posterior approach. Twenty-six patients (26 per cent) had supplemental cervical instrumentation as part of the circumferential arthrodesis: seventeen had insertion of an anterior cervical plate and nine had insertion of a posterior facet plate. There were no iatrogenic neurological deficits. Of the seventy-five patients who had had a neurological deficit preoperatively, fifty-one improved one grade and six improved two grades according to the system of Frankel et al. Of the thirty-five patients who had not been able to walk preoperatively, twenty-one regained enough motor strength to walk postoperatively. Because the anterior and posterior procedures were performed during one session of general anesthesia, the prevalence of perioperative complications related to the airway was lower than that previously reported in the literature. No patient had an obstruction of the airway. <> Spine and Scoliosis Center, St. Joseph's Hospital, Baltimore, USA.

    • Palumbo MA, Hilibrand AS, Hart RA and Bohlman HH (2001). Surgical treatment of thoracic spinal stenosis: a 2- to 9-year follow- up. Spine. 26 (5): 558-66. Summary: STUDY DESIGN: A retrospective investigation of the results of operative treatment of patients with symptomatic thoracic spinal stenosis. OBJECTIVES: To establish the effectiveness and define the limitations of surgical treatment for stenosis of the thoracic spinal canal. SUMMARY OF BACKGROUND DATA: In contrast to cervical and lumbar stenosis, symptomatic narrowing of the thoracic spinal canal is rarely encountered. Although the treatment of thoracic stenosis has been described in multiple case reports and in several small series with minimal follow-up evaluation, there are few studies of patients treated surgically for this condition with follow-up evaluation beyond 2 years. METHODS: Twelve patients who underwent operative decompression for symptomatic stenosis of the lower thoracic spine were followed up for an average period of 62.4 months. Surgery was performed on the thoracic spine alone in four cases and on the combined thoracolumbar spine in eight. Factors that were investigated included pain severity, lower extremity motor function, ambulatory status, and postoperative complications. RESULTS: The level of pain after surgery was decreased in eight patients and unchanged in four patients. Of the 10 patients with a motor deficit before surgery, eight had improvement of muscle function. Of the 11 patients with a gait disturbance before surgery, ambulatory status was improved in seven, unchanged in two, and worse in two. One patient lost neural function secondary to surgical intervention. There were five cases in which the early result subsequently deteriorated because of recurrent stenosis, spinal deformity/instability, or both. CONCLUSIONS: Thoracic stenosis can occur in isolation or, more commonly, in association with lumbar stenosis. Ideally, operative treatment should address all stenotic segments and directly decompress the primary anatomic abnormalities causing neural element compression. Although satisfactory short-term results can be expected, deterioration of the early outcome because of the potential for recurrent stenosis and deformity/instability at the thoracolumbar junction can sometimes be seen with longer follow-up evaluation periods. <> University Hospitals Spine Institute, Department of Orthopaedic Surgery, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

    • Phillips FM, Carlson GD, Bohlman HH and Hughes SS (2000). Results of surgery for spinal stenosis adjacent to previous lumbar fusion. J Spinal Disord. 13 (5): 432-7. Summary: The literature provides little data to guide surgical management of spinal stenosis adjacent to previous lumbar fusion. Thirty-three consecutive patients who had surgical decompression for spinal stenosis at the lumbar segments adjacent to a previous lumbar fusion were studied. The mean interval between fusion and the adjacent segment surgery was 94 months. Of the 33 patients, 26 were followed for 3-14 years (mean: 5 years) after adjacent segment surgery and were clinically evaluated and independently completed an outcome questionnaire. Of the 26 patients, 15 rated their outcome as completely satisfactory, 6 were neutral toward the surgery, and 5 considered their surgery a failure. The surgery was generally effective at improving or relieving lower extremity neurogenic claudication. The strongest independent predictive factor of patient dissatisfaction was ongoing postoperative low back pain (r = 0.7, p = 0.001). A higher back pain score at follow-up was associated with continued narcotic use (p = 0.001) and decreased ability to perform activities of daily living (p = 0.05). Six patients required further lumbar surgery during the follow- up period. This study provides the longest published follow-up data of surgical results for symptomatic spinal stenosis adjacent to a previously asymptomatic lumbar fusion. <> University of Chicago Spine Center, Illinois 60640, USA.

    • Riew KD, Hilibrand AS, Palumbo MA and Bohlman HH (1999). Anterior cervical corpectomy in patients previously managed with a laminectomy: short-term complications. J Bone Joint Surg Am. 81 (7): 950-7. Summary: BACKGROUND: The purpose of this study was to evaluate the complications of anterior cervical corpectomy and arthrodesis in patients who had had a previous cervical laminectomy. The results of previous studies have suggested that these patients can be managed with anterior decompression and an arthrodesis with either plate fixation or immobilization in a halo vest. However, no studies that we are aware of have specifically focused on the complications of these types of procedures. METHODS: The records and radiographs of eighteen patients who had been managed with a one to four-level corpectomy with strut- grafting were retrospectively reviewed. The reviews were independently performed by the three of us who were not involved in the original operation. The interval between the laminectomy and the corpectomy ranged from one month to twenty-two years (mean, eight years). RESULTS: Eleven of the eighteen patients sustained a total of sixteen complications during the follow-up period, which averaged 2.7 years (range, seven months to six years and four months), and nine of the eleven had graft-related complications. Five grafts extruded or collapsed, or both. There were four reoperations. Immobilization in a halo vest did not prevent extrusions, as three of the four extrusions occurred while the patient wore a halo vest. Four patients had a pseudarthrosis. In three patients, the kyphosis increased by 10 degrees or more from the immediate preoperative period to the most recent follow-up evaluation. Two patients had respiratory distress that necessitated reintubation, one patient had a small dural tear, and one had transient dysphagia. CONCLUSIONS: Our data suggest that anterior cervical corpectomy without instrumentation in a patient who has had a previous laminectomy is associated with a great risk of graft-related complications despite the use of a halo vest. This previously unreported finding is relevant in that it contradicts the recommendation previously made by Zdeblick and the senior one of us, who advocated postoperative immobilization in a halo vest for these patients. Anterior cervical corpectomy should be performed with caution and knowledge of the potential complications in a patient who has had a previous laminectomy. <> Department of Orthopaedic Surgery, Case Western Reserve University School of Medicine, Cleveland, Ohio 44106, USA.

    [This message was edited by Wise Young on October 03, 2001 at 07:36 AM.]

  8. #8
    how can you tell if you are a good candidate for decompression surgery? Is an MRI enough? In your opinion, what would justify having the surgery? Is it necessary to go ahead and open up the person in order to find out if there is compression?

  9. #9
    Carl R, the first step is the determine whether you have a compression. This can be ascertained on MRI. Once you have a clearly identified compression, you have to find a surgeon who is willing to decompress you. Many surgeons believe that decompression will not do much to restore function and therefore will not do decompression for chronic spinal cord injury, unless the person is getting worse. A third consideration is where the injury site is located. If it is close to a place where relief of compression the segmental level itself may yield significant function, this would be a strong argument for decompressing.


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