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Physical Capability OutcomesNCT01055574

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

An observational study of Physical Capability Outcomes, run by Gundersen Lutheran Medical Foundation at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Physical Capability Outcomes
How many people
45 participants
Where
6 sitesUnited States
Study dates
Oct 2009to Jan 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Colorado Denver

    Denver, Colorado

  • Gundersen Lutheran Health System

    La Crosse, Wisconsin, 54601

  • Orthopaedic Surgery Associates of Marquette, PC

    Marquette, Michigan, 49855

  • Christiana Spine Center

    Newark, Delaware, 19713

  • Texas Back Institute

    Plano, Texas, 75093

  • Capital Regional Medical Center

    Tallahassee, Florida, 32308

Other trials in United States

About this study

Official title: Physical Capability Outcomes After Single-Level ProDisc-L Total Disc Replacement or Single-Level Anterior Lumbar Interbody Fusion: a Multi-Center Clinical Trial

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.

Read the detailed description

Physical capability testing will be conducted once before surgery and at 6 months and 1 year after surgery. Physical capability testing assesses the ability to perform a number of common tasks: the distance a subject can walk comfortably in 6 minutes; the amount of weight a subject can lift, push, pull, and carry; and the ability to squat and work bending forward in the kneeling and standing positions. The results of this testing will be evaluated to determine whether the subject's physical capability meets the physical requirements of their job, based on their responses to a pre-study questionnaire. Each physical capability testing session will require from 1 to 1 ½ hours of the subject's time. Physical capability testing will be provided without charge.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01055574
Study groupRoleWhat they receive
ProDisc-LSubjects 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (4)

  1. Oswestry Disability Index

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

  2. EQ-5D Health Questionnaire

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

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

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

  4. SF-36 scores for the 8 Domains

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionDec 2011 (estimated)
  4. Study completionJan 2012 (estimated)

Why it stopped: Unanticipated study design flaw; PCO evaluator interrater reliability was not performed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01055574
Sponsor's protocol ID
2-09-05-002
Other IDs
20092359
Status last verified
Sep 2011
First submitted
22 Jan 2010
Last updated
9 Sep 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 9636981

  • 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.

    PubMed 15911537

  • 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.

    PubMed 16205353

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

    PubMed 11795725

  • 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.

    PubMed 16025025

  • 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.

    PubMed 11725230

  • 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.

    PubMed 12973134

  • 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.

    PubMed 16025024

  • 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.

    PubMed 17495770

  • 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.

    PubMed 16891976

  • 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.

    PubMed 12902949

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

    PubMed 11922852

  • 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.

    PubMed 15638259

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Capability Outcomes, run by Gundersen Lutheran Medical Foundation at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Unanticipated study design flaw; PCO evaluator interrater reliability was not performed.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: pre-op, at 6mo., and at 12mo.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01055574, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2011.

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