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临床试验/NCT00205101
NCT00205101已完成不适用

Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2004年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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