Physical Capability Outcomes After Single-Level PD-L vs Single-Level ALIF: a Multi-Center Clinical Trial
NCT ID: NCT01055574
Last Updated: 2011-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
45 participants
OBSERVATIONAL
2009-10-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ProDisc-L
Subjects who received single-level ProDisc-L total disc replacement prior to physical capability evaluations
No interventions assigned to this group
anterior lumbar interbody fusion (AILF)
Subjects who received single-level anterior lumbar interbody fusion prior to physical capability evaluations
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* skeletally mature; BMI \< 40
* suffered from low-back pain with or without leg pain for 6 months or longer
* no evidence of spinal deformity on plain radiograph
* no evidence of angular instability on flexion extension radiographs
* severe and incapacitating low-back pain, defined as a score of 40% or greater on the Oswestry Disability Questionnaire
* a single level of degenerative disc disease at L34, L45, or L5-S1 on magnetic resonance imaging (MRI) scan
* discography, if indicated, reproduces pain at the level of degeneration noted on the MRI scan and is negative for pain reproduction at adjacent levels
* bone mineral density T-Score by DEXA Scan \>-1.0 for any skeletal region
* computed tomographic (CT) scan demonstrates the absence of pars defect at the index level
* CT scan demonstrates the absence of significant facet arthropathy at the index level
* considered reasonable candidates for surgery in regard to psychological factors as determined according to the standard of care at each participating center
Exclusion Criteria
* evidence of alcoholism
* spondylolisthesis of greater than grade 1
* clinically significant lumbar spinal stenosis
* allergy to implant materials
* isolated radicular syndrome
* vertebral body compromised by trauma at the index level.
18 Years
60 Years
ALL
Yes
Sponsors
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Synthes USA HQ, Inc.
INDUSTRY
Gundersen Lutheran Medical Foundation
OTHER
Responsible Party
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Humbert (Drew) Sullivan
Chair, Department of Neurosurgery
Principal Investigators
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Humbert (Drew) G Sullivan, MD
Role: PRINCIPAL_INVESTIGATOR
Gundersen Lutheran Health System, LaCrosse, WI
Jack E Zigler, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Back Institute, Plano, TX
John G Devine, MD
Role: PRINCIPAL_INVESTIGATOR
Eisenhower Army Medical Center, Augusta, GA
Locations
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University of Colorado Denver
Denver, Colorado, United States
Christiana Spine Center
Newark, Delaware, United States
Capital Regional Medical Center
Tallahassee, Florida, United States
Orthopaedic Surgery Associates of Marquette, PC
Marquette, Michigan, United States
Texas Back Institute
Plano, Texas, United States
Gundersen Lutheran Health System
La Crosse, Wisconsin, United States
Countries
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References
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Kuslich SD, Ulstrom CL, Griffith SL, Ahern JW, Dowdle JD. The Bagby and Kuslich method of lumbar interbody fusion. History, techniques, and 2-year follow-up results of a United States prospective, multicenter trial. Spine (Phila Pa 1976). 1998 Jun 1;23(11):1267-78; discussion 1279. doi: 10.1097/00007632-199806010-00019.
Fairbank J, Frost H, Wilson-MacDonald J, Yu LM, Barker K, Collins R; Spine Stabilisation Trial Group. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ. 2005 May 28;330(7502):1233. doi: 10.1136/bmj.38441.620417.8F. Epub 2005 May 23.
Bertagnoli R, Yue JJ, Shah RV, Nanieva R, Pfeiffer F, Fenk-Mayer A, Kershaw T, Husted DS. 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. Spine (Phila Pa 1976). 2005 Oct 1;30(19):2230-6. doi: 10.1097/01.brs.0000182217.87660.40.
Bao QB, Yuan HA. Prosthetic disc replacement: the future? Clin Orthop Relat Res. 2002 Jan;(394):139-45. doi: 10.1097/00003086-200201000-00016.
McAfee PC, Cunningham B, Holsapple G, Adams K, Blumenthal S, Guyer RD, Dmietriev A, Maxwell JH, Regan JJ, Isaza J. A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine (Phila Pa 1976). 2005 Jul 15;30(14):1576-83; discussion E388-90. doi: 10.1097/01.brs.0000170561.25636.1c.
Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.
Brox JI, Sorensen R, Friis A, Nygaard O, Indahl A, Keller A, Ingebrigtsen T, Eriksen HR, Holm I, Koller AK, Riise R, Reikeras O. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1913-21. doi: 10.1097/01.BRS.0000083234.62751.7A.
Blumenthal S, McAfee PC, Guyer RD, Hochschuler SH, Geisler FH, Holt RT, Garcia R Jr, Regan JJ, Ohnmeiss DD. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine (Phila Pa 1976). 2005 Jul 15;30(14):1565-75; discussion E387-91. doi: 10.1097/01.brs.0000170587.32676.0e.
Zigler J, Delamarter R, Spivak JM, Linovitz RJ, Danielson GO 3rd, Haider TT, Cammisa F, Zuchermann J, Balderston R, Kitchel S, Foley K, Watkins R, Bradford D, Yue J, Yuan H, Herkowitz H, Geiger D, Bendo J, Peppers T, Sachs B, Girardi F, Kropf M, Goldstein J. Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine (Phila Pa 1976). 2007 May 15;32(11):1155-62; discussion 1163. doi: 10.1097/BRS.0b013e318054e377.
Chung SS, Lee CS, Kang CS. Lumbar total disc replacement using ProDisc II: a prospective study with a 2-year minimum follow-up. J Spinal Disord Tech. 2006 Aug;19(6):411-5. doi: 10.1097/00024720-200608000-00007.
Gillet P. The fate of the adjacent motion segments after lumbar fusion. J Spinal Disord Tech. 2003 Aug;16(4):338-45. doi: 10.1097/00024720-200308000-00005.
Gross DP, Battie MC. Reliability of safe maximum lifting determinations of a functional capacity evaluation. Phys Ther. 2002 Apr;82(4):364-71.
Reneman MF, Brouwer S, Meinema A, Dijkstra PU, Geertzen JH, Groothoff JW. Test-retest reliability of the Isernhagen Work Systems Functional Capacity Evaluation in healthy adults. J Occup Rehabil. 2004 Dec;14(4):295-305. doi: 10.1023/b:joor.0000047431.40598.47.
Other Identifiers
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20092359
Identifier Type: OTHER
Identifier Source: secondary_id
2-09-05-002
Identifier Type: -
Identifier Source: org_study_id
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