RecruitingNCT05070078

The Single Assessment Numeric Evaluation (SANE) for Lumbar Discectomy

The Single Assessment Numeric Evaluation (SANE): Is a Reliable Metric to Measure Clinically Significant Improvements After Lumbar Discectomy


Sponsor

Windsor-Essex Compassionate Care Community

Enrollment

400 participants

Start Date

Nov 10, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a simple, single-question assessment tool called the Single Assessment Numeric Evaluation (SANE) can accurately measure how a patient feels about their recovery after lumbar discectomy — a surgery to remove part of a herniated disc pressing on a spinal nerve. You may be eligible if: - You are over 18 years of age - You are undergoing lumbar discectomy surgery - You are willing to comply with at least 1 year of follow-up You may NOT be eligible if: - You have had previous lumbar spine surgery - You are in the pediatric age group (under 18) - You have less than 1 year of postoperative follow-up available - You need spinal fixation for instability - You have cauda equina syndrome - You are a non-compliant patient Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Windsor Regional Hospital - Ouellette

Windsor, Ontario, Canada

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NCT05070078


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