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OpenTrials
Completed

NCT Number: NCT00205101

Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion

The purpose of the study is to prospectively measure pain, function, and patient satisfaction in 70 consecutive patients treated by lumbar fusion using the Triad allograft. Results of the Triad allograft will be compared to those of other anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF) surgeries. Patient participation is based on the physician determination that the patient requires one of these surgeries. Participants will be evaluated pre-operatively and post-operatively at 3, 6, 12,and 24 month intervals. Clinic procedures will be related to standard of care except for the completion of several study questionnaires:

1. Back Pain Questionnaire; 2. Oswestry Disability Index Questionnaire; 3. Short Form-36 (SF-36) Survey; 4. Visual Analog Pain Scale (VAS); and 5. The Modems Patient Satisfaction Survey.

Outcome Measurements:

1. The patient's pain is scored by a VAS normalized to 100; 2. Patient function is based on Oswestry scores; 3. General health is assessed by SF-36 completion; and 4. Overall patient satisfaction will be determined by the completion of the Modems.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UW Health Spine Clinic

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary consent for an observational study
  • One of the following diagnoses:
  • isthmic spondylolisthesis,
  • degenerative spondylolisthesis,
  • pseudoarthritis,
  • severe foraminal stenosis, and
  • prior failed discectomies
  • Single, two, or three level fusions
  • Patients require treatment by TLIF or PLIF posterior fusion as determined by surgeon. Pedicle screw instrumentation will be placed in all cases.

Exclusion criteria

  • Infection at operative site
  • Severe osteoporosis
  • Inability to return for follow-up.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • NuVasive

Registry information

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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