Registry for Evaluation of Lumbar Arthrodesis Sagittal alignmEnt

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.

Conditions

• Lumbar Spine Disease
• Instabilities Lumbar
• Lumbar Spine Instability

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation

  collaborator OTHER

• University of Roma La Sapienza

  collaborator OTHER

• Istituto Clinico Humanitas

  collaborator OTHER

• Niguarda Hospital

  collaborator OTHER

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

  collaborator OTHER

• Istituto Clinico Città Studi, Milan

  collaborator UNKNOWN

• ASST Gaetano Pini-CTO

  collaborator OTHER

• ASST Fatebenefratelli Sacco

  collaborator OTHER

• Città di Pavia Clinic, Pavia

  collaborator UNKNOWN

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• Azienda Ospedaliera, Ospedale Civile di Legnano

  collaborator OTHER

• A.O. Ospedale Papa Giovanni XXIII

  collaborator OTHER

• University of Siena

  collaborator OTHER

• Humanitas Research Hospital IRCCS, Rozzano-Milan

  collaborator OTHER

• University of Pavia

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Orthopedic Specialty Institute

  collaborator INDUSTRY

• Carlo Besta Neurological Institute

  collaborator OTHER

• Unit of neurosurgery, Departement of Neurosciences, University of Torino

  lead OTHER

Principal Investigators

• Fulvio Tartara, MD · Humanitas Hospital, Italy

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2022-06-26

Completion

2025-06-26

Countries

• Italy

Study Locations