Physical Capability Outcomes After Single-Level PD-L vs Single-Level ALIF: a Multi-Center Clinical Trial

NCT01055574 | Terminated DMC

• 2 other identifiers: 2-09-05-00220092359
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to compare the physical capability outcomes of patients who undergo single-level ProDisc-L disc replacement with those of patients who undergo stand-alone, single-level anterior lumbar interbody fusion (ALIF). This study will be the first multi-center clinical study to use clearly measurable outcomes from physical tests to compare the results of lumbar disc arthroplasty with disc fusion.

Conditions

Physical Capability Outcomes

Keywords

lumbar disc arthroplasty; total disc replacement; ProDisc L; anterior lumbar interbody fusion; lumbar spine surgery outcomes

Outcome Measures

Primary Outcomes (1)

• Change in physical capability outcomes (6 minute walk; squats; light board game task standing bent forward /kneeling; floor-to-waist lift; horizontal lift; static push/pull force)

  pre-op, at 6mo., and at 12mo.

Secondary Outcomes (4)

• Oswestry Disability Index

  pre-op, at 6mo., and at 12mo

• EQ-5D Health Questionnaire

  pre-op, at 6mo., and at 12mo.

• Visual Analog Scale (VAS) scores for pain severity and frequency

  pre-op, at 6mo., and at 12mo.

• SF-36 scores for the 8 Domains

  pre-op, at 6mo., and at 12mo.

Study Arms (2)

ProDisc-L

Subjects who received single-level ProDisc-L total disc replacement prior to physical capability evaluations

anterior lumbar interbody fusion (AILF)

Subjects who received single-level anterior lumbar interbody fusion prior to physical capability evaluations

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The target study population are those meeting all the FDA criteria for ProDisc-L. Patients with third-party coverage for ProDisc-L that received surgical implantation of this device will be in one group. Patients without third-party coverage for ProDisc-L that underwent stand-alone ALIF with a device that incorporates fixation of the superior vertebral body to the inferior vertebral body, and where an osteoinductive biologic agent is placed within the device will be in the other group.

You may qualify if:

• Eligible patients will meet the following criteria based on clinically appropriate criteria per standard of care at individual institutions which may include but are not limited to
• 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

You may not qualify if:

• active systemic infection
• 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.

Sponsors & Collaborators

• Gundersen Lutheran Medical Foundation: lead
• Synthes USA HQ, Inc.: collaborator

Study Sites (6)

University of Colorado Denver

Denver, Colorado, United States

Location

Christiana Spine Center

Newark, Delaware, 19713, United States

Location

Capital Regional Medical Center

Tallahassee, Florida, 32308, United States

Location

Orthopaedic Surgery Associates of Marquette, PC

Marquette, Michigan, 49855, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

Gundersen Lutheran Health System

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (13)

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• 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.

  PMID: 15911537 BACKGROUND

• 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.

  PMID: 16205353 BACKGROUND

• Bao QB, Yuan HA. Prosthetic disc replacement: the future? Clin Orthop Relat Res. 2002 Jan;(394):139-45. doi: 10.1097/00003086-200201000-00016.

  PMID: 11795725 BACKGROUND

• 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.

  PMID: 16025025 BACKGROUND

• 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.

  PMID: 11725230 BACKGROUND

• 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.

  PMID: 12973134 BACKGROUND

• 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.

  PMID: 16025024 BACKGROUND

• 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.

  PMID: 17495770 BACKGROUND

• 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.

  PMID: 16891976 BACKGROUND

• 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.

  PMID: 12902949 BACKGROUND

• Gross DP, Battie MC. Reliability of safe maximum lifting determinations of a functional capacity evaluation. Phys Ther. 2002 Apr;82(4):364-71.

  PMID: 11922852 BACKGROUND

• 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.

  PMID: 15638259 BACKGROUND

Study Officials

• Humbert (Drew) G Sullivan, MD

  Gundersen Lutheran Health System, LaCrosse, WI

  PRINCIPAL INVESTIGATOR

• Jack E Zigler, MD

  Texas Back Institute, Plano, TX

  PRINCIPAL INVESTIGATOR

• John G Devine, MD

  Eisenhower Army Medical Center, Augusta, GA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Neurosurgery

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 25, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: September 9, 2011

Record last verified: 2011-09

Locations

US (6)