NCT05070078

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Nov 2021Dec 2028

First Submitted

Initial submission to the registry

September 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 10, 2021

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2028

Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

7.1 years

First QC Date

September 5, 2021

Last Update Submit

April 22, 2024

Conditions

Lumbar Discectomy

Keywords

Lumbar DiscectomySingle Assessment Numeric EvaluationPatient Reported Outcome Measures

Outcome Measures

Primary Outcomes (1)

  • Correlation of SANE score

    To correlate and confirm that SANE score to the more lengthy and burdensome legacy PROMs used in spine surgery research today. Spearman's correlation and linear regression will be performed for each time point, and for the change from preoperative to final follow up to validate the SANE as compared to the other PROMs.

    November 2022

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing lumbar discectomy.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Windsor Regional Hospital - Ouellette

Windsor, Ontario, N9A 1E1, Canada

RECRUITING

Related Publications (4)

  • Shelbourne KD, Barnes AF, Gray T. Correlation of a single assessment numeric evaluation (SANE) rating with modified Cincinnati knee rating system and IKDC subjective total scores for patients after ACL reconstruction or knee arthroscopy. Am J Sports Med. 2012 Nov;40(11):2487-91. doi: 10.1177/0363546512458576. Epub 2012 Sep 12.

    PMID: 22972851BACKGROUND

  • Stokes OM, Cole AA, Breakwell LM, Lloyd AJ, Leonard CM, Grevitt M. Do we have the right PROMs for measuring outcomes in lumbar spinal surgery? Eur Spine J. 2017 Mar;26(3):816-824. doi: 10.1007/s00586-016-4938-x. Epub 2017 Jan 9.

    PMID: 28070683BACKGROUND

  • Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50. doi: 10.1001/jama.296.20.2441.

    PMID: 17119140BACKGROUND

  • Torchia MT, Austin DC, Werth PM, Lucas AP, Moschetti WE, Jevsevar DS. A SANE Approach to Outcome Collection? Comparing the Performance of Single- Versus Multiple-Question Patient-Reported Outcome Measures After Total Hip Arthroplasty. J Arthroplasty. 2020 Jun;35(6S):S207-S213. doi: 10.1016/j.arth.2020.01.015. Epub 2020 Jan 16.

    PMID: 32008770RESULT

Study Officials

  • Mohamed Soliman

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Soliman, MD

CONTACT

17329241637moh.ar.sol@kasralainy.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgeon, Principal Investigator

Study Record Dates

First Submitted

September 5, 2021

First Posted

October 6, 2021

Study Start

November 10, 2021

Primary Completion (Estimated)

December 10, 2028

Study Completion (Estimated)

December 10, 2028

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

CA(1)