Actively Recruiting

Age: 18Years +
All Genders
NCT05070078

The Single Assessment Numeric Evaluation (SANE) for Lumbar Discectomy

Led by Windsor-Essex Compassionate Care Community · Updated on 2024-04-23

400

Participants Needed

1

Research Sites

369 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

The Single Assessment Numeric Evaluation (SANE) for Lumbar Discectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years of age undergoing a lumbar discectomy.
Not Eligible

You will not qualify if you...

  • Previous history of lumbar surgery.
  • Pediatric age group.
  • Patients with a postoperative follow-up time of less than 1 year.
  • Unstable patients in need of fixation.
  • Patients with cauda equina syndrome.
  • Non-compliant patients.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Windsor Regional Hospital - Ouellette

Windsor, Ontario, Canada, N9A 1E1

Actively Recruiting

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Research Team

M

Mohamed Soliman, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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