UnknownNot Applicable

Registry for Evaluation of Lumbar Arthrodesis Sagittal alignmEnt

Italy500 participantsStarted 2022-06-01

Plain-language summary

The study goal of RELApSE is to evaluate the relationships between radiological data and patients reported outcome. Restoration of Sagittal alignment and Pelvic Index (PI)-Lumbar Lordosis (LL) mismatch is closely associated with a better outcome in spinal deformities, while there is still a lack of consistent evidence regarding short-segment arthrodesis for lumbar degenerative pathology. Over the past 10 years, an increasing number of publications reported associations between the presence of PI-LL mismatch, reduced lumbar lordosis, increased pelvic tilt, and outcome of lumbar arthrodesis for degenerative lumbar disease. Other authors, on the other hand, reported an absence of correlation between the same parameters and clinical outcome. In addition, several authors have been reported evidence regarding association of adjacent level disc degeneration and elevated pelvic tilt, persistent PI-LL mismatch and altered LL4-S1/LL ratio. Also on this aspect, other studies identify different elements as predisposing factors for junctional pathology. The definitive value for lumbar degenerative pathology of these aspects in relation to the surgical outcome remains to be clarified without consolidated evidence. The RELApSE study is the first prospective and multicenter study on these topics. Starting from a very heterogeneous population in terms of clinical conditions, pathology and surgical treatment options, the study methods is to make the population homogeneous on some data available in all patients end that can be analyzed independently. These data are: pelvic parameters (pelvic incidence, pelvic tilt, sacral slope), segmental lumbar lordosis (LS), global lumbar lordosis (LL), PI-LL mismatch and L4-S1/LL lordosis ratio; clinical results based on administered questionnaires (Oswestry disability index, Short Form-12) and overall outcome assessment at FU (6 point scale: excellent (completely resolved symptoms), good (good clinical improvement, minor symptoms), fair (improvement compared to preoperative but still with relevant symptoms), unchanged (symptoms similar to preoperative), negative (worsening of symptoms compared to preoperative); severely worsened (reduction of personal autonomy compared to preoperative due to neurological deficits); occurrence of symptomatic junctional pathology (yes / no), need for surgical revision of the operated level (yes / no) or of the adjacent level (yes / no).No interference is foreseen on the patient's diagnostic-therapeutic path or technical treatment options chosen by partecipating surgeons. Furthermore, no form of experimentation with techniques or materials is envisaged. Data collection is prospective in the context of normal clinical activity.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * undergoing an instrumented lumbar arthrodesis operation at 1, 2 or 3 levels. * age between 18 and 75 years. * agree of inclusion in the study with subscription of informed consent, available for 5 years follow-up, including phone interviews. * availability of adequate preoperative radiological documentation: CT or MRI of the lumbar spine; standing lumbar spine x-ray performed in a neutral position in which the pelvic parameters (pelvic incidence, pelvic tilt) and all lumbar segments can be correctly assessed * availability of adequate and comprehensive clinical information including the presence of preoperative ODI (Oswestry Disability Index) and SF-12. * availability of adequate information regarding surgery * availability of postoperative radiological documentation: lumbar spine X-ray with the same requirements as point 4 performed in the postoperative period and at 1 year follow-up. * availability of adequate and comprehensive clinical information including ODI score (Oswestry Disability Index) and SF-12 questionnaire at follow-up. The minimum follow-up for each patient included must be 12 months, to be continued for a total of 5 years. Exclusion Criteria: * Patients who, although already enrolled, do not meet the inclusion criteria will be excluded. * Patients who, regardless of age, have a life expectancy of less than 5 years due to associated diseases, must be excluded from the study. * Patients who, for various reasons, have to withdraw their c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of Clinical Status

Timeframe: 5 years

Trial details

NCT IDNCT05448092

SponsorUnit of neurosurgery, Departement of Neurosciences, University of Torino

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-26

View on ClinicalTrials.gov More Lumbar Spine Disease trials