NCT05070078 The Single Assessment Numeric Evaluation (SANE) for Lumbar Discectomy
| NCT ID | NCT05070078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Windsor-Essex Compassionate Care Community |
| Condition | Lumbar Discectomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2021-11-10 |
| Primary Completion | 2028-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2021-11-10 with a primary completion date of 2028-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Mohamed Soliman
PRINCIPAL INVESTIGATOR
Cairo University
Frequently Asked Questions
Who can join the NCT05070078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lumbar Discectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05070078 currently recruiting?
Yes, NCT05070078 is actively recruiting participants. Contact the research team at moh.ar.sol@kasralainy.edu.eg for enrollment information.
Where is the NCT05070078 trial being conducted?
This trial is being conducted at Windsor, Canada.
Who is sponsoring the NCT05070078 clinical trial?
NCT05070078 is sponsored by Windsor-Essex Compassionate Care Community. The principal investigator is Mohamed Soliman at Cairo University. The trial plans to enroll 400 participants.