Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00205101
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2005-09-13
Brief Title:
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 12and 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 patients 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
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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None