Lumbar DiscectomyNCT05070078
The Single Assessment Numeric Evaluation (SANE) for Lumbar Discectomy
An observational study of Lumbar Discectomy, run by Windsor-Essex Compassionate Care Community at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Discectomy
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 10 Nov 2021to 10 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing lumbar discectomy.
Who may be able to join
- Patient over 18 years of age undergoing a lumbar discectomy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Windsor Regional Hospital - Ouellette
Windsor, Ontario, N9A 1E1
Abdalla Shamisa, MD, abdalla.shamisa@wrh.on.ca
Balraj Jhawar, MD, bsjhawar@hotmail.com
About this study
Official title: The Single Assessment Numeric Evaluation (SANE): Is a Reliable Metric to Measure Clinically Significant Improvements After Lumbar Discectomy
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).
Read the detailed description
Background/Rational: 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. When considered in concert, these instruments quantify and stratify an individual's health state before and after surgery and can be utilized to perform research as well as inform clinical practice. 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. Ideally, a PROM would provide sufficient information to define health status longitudinally, while requiring the least amount of time and effort to complete. The current approach to PROMs in spine surgery research has been mostly to require an assessment of pain, disease specific disability and general health, requiring answers for up to of 40 unique questions, despite efforts to shorten the questionnaires in other neurosurgery and orthopedics disciplines.
The Single Assessment Numeric Evaluation (SANE) score is one such example of a limited question survey that aims to assess multiple domains. The 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).
Design: Survey research design, prospective outcomes measure validation study.
Objectives: We hypothesized that the SANE score would correlate strongly and demonstrate similar magnitudes of longitudinal responsiveness with the more lengthy and burdensome legacy PROMs used in spine surgery research today.
Primary Objective: To correlate and confirm that SANE score to the more lengthy and burdensome legacy PROMs used in spine surgery research today.
Secondary Objective: There are multiple secondary aims of this study as shown below.
- Evaluate patients' satisfaction after surgery.
- Assess efficacy of treatment over time.
- Evaluate patients' sense of functional improvement after lumbar disc procedures.
Information gained from this study will greatly enhance our ability to know whether SANE correlates with PROMS. Although the results of the trial will not directly benefit all the individuals participating, information gathered from this study can help future patients by reducing the burden of completing lengthy surveys and minimizing survey fatigue.
- Conditions
- Lumbar Discectomy
- Keywords
- Lumbar Discectomy, Single Assessment Numeric Evaluation, Patient Reported Outcome Measures
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: November 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start10 Nov 2021
- Primary completion10 Dec 2028 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lumbar DiscectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Windsor-Essex Compassionate Care Community
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Soliman, Windsor-Essex Compassionate Care Community
- Investigators
- Mohamed Soliman, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070078
- Sponsor's protocol ID
- 21-409
- Status last verified
- Apr 2024
- First submitted
- 5 Sep 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22972851Stokes 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.
PubMed 28070683Weinstein 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.
PubMed 17119140Torchia 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.
PubMed 32008770
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Single Assessment Numeric Evaluation (SANE): Is a Reliable Metric to Measure Clinically Significant Improvements After Lumbar Discectomy
- ClinicalTrials.gov ID
- NCT05070078
- Acronym / sponsor ID
- 21-409
- Conditions
- Lumbar Discectomy
- Keywords
- Lumbar Discectomy, Single Assessment Numeric Evaluation, Patient Reported Outcome Measures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Windsor-Essex Compassionate Care CommunityUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 10 Dec 2028 (estimated)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Background/Rational: 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. When considered in concert, these instruments quantify and stratify an individual's health state before and after surgery and can be utilized to perform research as well as inform clinical practice. 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. Ideally, a PROM would provide sufficient information to define health status longitudinally, while requiring the least amount of time and effort to complete. The current approach to PROMs in spine surgery research has been mostly to require an assessment of pain, disease specific disability and general health, requiring answers for up to of 40 unique questions, despite efforts to shorten the questionnaires in other neurosurgery and orthopedics disciplines.
The Single Assessment Numeric Evaluation (SANE) score is one such example of a limited question survey that aims to assess multiple domains. The 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).
Design: Survey research design, prospective outcomes measure validation study.
Objectives: We hypothesized that the SANE score would correlate strongly and demonstrate similar magnitudes of longitudinal responsiveness with the more lengthy and burdensome legacy PROMs used in spine surgery research today.
Primary Objective: To correlate and confirm that SANE score to the more lengthy and burdensome legacy PROMs used in spine surgery research today.
Secondary Objective: There are multiple secondary aims of this study as shown below.
- Evaluate patients' satisfaction after surgery.
- Assess efficacy of treatment over time.
- Evaluate patients' sense of functional improvement after lumbar disc procedures.
Information gained from this study will greatly enhance our ability to know whether SANE correlates with PROMS. Although the results of the trial will not directly benefit all the individuals participating, information gathered from this study can help future patients by reducing the burden of completing lengthy surveys and minimizing survey fatigue.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lumbar discectomy.
Key inclusion criteria (1 listed)
- Patient over 18 years of age undergoing a lumbar discectomy.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of SANE score
Time frame: November 2022
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Background: PubMed 22972851Shelbourne 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.
- Background: PubMed 28070683Stokes 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.
- Background: PubMed 17119140Weinstein 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.
- Results publication: PubMed 32008770Torchia 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Soliman principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Discectomy, run by Windsor-Essex Compassionate Care Community at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Soliman, MD (17329241637, moh.ar.sol@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of SANE score (time frame: November 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05070078, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.