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NCT05070078

The Single Assessment Numeric Evaluation (SANE) for Lumbar Discectomy

Recruiting now Last updated 23 April 2024
What this trial tests

trial in Lumbar Discectomy in 400 participants. Currently enrolling.

Timeline
10 November 2021
Primary endpoint
10 December 2028
10 December 2028

Quick facts

Lead sponsorWindsor-Essex Compassionate Care Community
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment400
Start date10 November 2021
Primary completion10 December 2028
Estimated completion10 December 2028
Sites1 location across Canada

Conditions studied

Sponsor

Windsor-Essex Compassionate Care Community

Who can join

18 and older, any sex, with Lumbar Discectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In the last several decades, many Patient Reported Outcomes Measures (PROMs) have been developed to provide assessment of patient health across multiple domains, as they relate to various spine conditions. However, many of the available PROM surveys have many questions and require substantial time to complete and/or assess one focal domain of health requiring multiple tools to achieve an overall assessment of well-being. Thus, concerns have arisen regarding patient survey fatigue and data integrity. The Single Assessment Numeric Evaluation (SANE) is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100. The SANE score has excellent acceptance in some orthopedic surgery research, where it has been shown responsiveness similar to more comprehensive legacy measures. The SANE thus eliminates survey fatigue and has been validated across a spectrum of orthopedic subspecialties. To our knowledge, however, the SANE has never been studied in a patient population undergoing any type of spinal surgery. Thus, we set out to compare the SANE score in patients undergoing lumbar discectomy to currently utilized PROM scores, including the Oswestry Disability Index (ODI), Zurich Claudication Scale (ZCS), and short form-36 (SF-36).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Lumbar Discectomy

Currently open trials in the same condition.

Other Windsor-Essex Compassionate Care Community trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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