Recruiting

SANE vs. PROMs

Sponsor:

Windsor-Essex Compassionate Care Community

Code:

NCT05070078

Conditions

Lumbar Discectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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).

Conditions

Lumbar Discectomy

Study ID

NCT05070078

Start date

Nov 10, 2021

Status verified date

Apr, 2024

Completion date

Dec 10, 2028

Anticipated

Primary completion date

Dec 10, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Correlation of SANE score [ Time Frame: November 2022 ]

Central Contacts and Locations

Central contacts

Locations

Windsor Regional Hospital - Ouellette

Recruiting

Windsor, Ontario, Canada, N9A 1E1

Contacts

Abdalla Shamisa, MD

abdalla.shamisa@wrh.on.ca

Balraj Jhawar, MD

bsjhawar@hotmail.com

More Information

Sponsor

Windsor-Essex Compassionate Care Community

Last update posted

Apr 23, 2024

Last verified

Apr, 2024

Keywords

  • Lumbar Discectomy
  • Single Assessment Numeric Evaluation
  • Patient Reported Outcome Measures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Windsor-Essex Compassionate Care Community on 2024-04-23.