The Single Assessment Numeric Evaluation (SANE) for Lumbar Discectomy

Recruiting now

Conditions studied: Lumbar Discectomy

In brief

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).

Key facts

Study ID

NCT05070078

Run by

Windsor-Essex Compassionate Care Community

People needed

400

Starts

2021-11-10

Expected to finish

2028-12-10

Last updated by the study team

2024-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient over 18 years of age undergoing a lumbar discectomy.

You may not qualify if…

• 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.

Where it is running

• Windsor Regional Hospital - Ouellette — Windsor, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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