Registry for Evaluation of Lumbar Arthrodesis Sagittal alignmEnt

NCT05448092 | Unknown DMC

• 1 other identifier: 012022
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Spine surgery; Surgical Arthrodesis; Lumbar degenerative disease; Sagittal balance assessment; Sagittal alignment

Outcome Measures

Primary Outcomes (1)

• Change of Clinical Status

  Measured changed based on the presence of post-operative radicular pain (Yes/no), presence of claudication, debut of neurological deficits (measured and reported using scale as ODI, SF-12 MCS, SF-12 PCS), the primary outcome is reported as Improved, Stable or Worsening.

  5 years

Secondary Outcomes (3)

• Adverse events

  5 years

• Presence of post-operative complications

  5 years

• Occurrence of Junctional post-operative pathology

  5 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study includes an adult population of patients with surgically treated degenerative disease of the lumbar spine.

You may qualify if:

• undergoing an instrumented lumbar arthrodesis operation at 1, 2 or 3 levels.
• age between 18 and 75 years.
• 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.

You may not qualify if:

• 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 consent to be included in the study in writing will also be excluded.

Sponsors & Collaborators

• Unit of neurosurgery, Departement of Neurosciences, University of Torino: lead
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• University of Roma La Sapienza: collaborator
• Istituto Clinico Humanitas: collaborator
• Niguarda Hospital: collaborator
• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: collaborator
• Istituto Clinico Città Studi, Milan: collaborator
• ASST Gaetano Pini-CTO: collaborator
• ASST Fatebenefratelli Sacco: collaborator
• Città di Pavia Clinic, Pavia: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Azienda Ospedaliera, Ospedale Civile di Legnano: collaborator
• A.O. Ospedale Papa Giovanni XXIII: collaborator
• University of Siena: collaborator
• Humanitas Research Hospital IRCCS, Rozzano-Milan: collaborator
• University of Pavia: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Orthopedic Specialty Institute: collaborator
• Carlo Besta Neurological Institute: collaborator

Study Sites (8)

Orthopedics Unit, Policlinico di Bari, University of Bari

Bari, Italy

Location

Humanitas

Milan, Italy

Location

IRCCS Galeazzi Orthopedic Institute

Milan, Italy

Location

IRCCS Neurological Institute Carlo Besta

Milan, Italy

Location

Neurosurgery, Ospedale Maggiore Policlinico, University of Milan

Milan, Italy

Location

Orthopedics and traumatology Unit, Niguarda Hospital

Milan, Italy

Location

Department of Neurosurgery University Sapienza of Rome

Rome, Italy

Location

A.O.U. Città della Salute e della Scienza

Turin, Italy

Location

Related Publications (9)

• Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.

  PMID: 30560029 BACKGROUND

• Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.

  PMID: 30074971 BACKGROUND

• Makino T, Kaito T, Fujiwara H, Honda H, Sakai Y, Takenaka S, Yoshikawa H, Yonenobu K. Risk Factors for Poor Patient-Reported Quality of Life Outcomes After Posterior Lumbar Interbody Fusion: An Analysis of 2-Year Follow-up. Spine (Phila Pa 1976). 2017 Oct 1;42(19):1502-1510. doi: 10.1097/BRS.0000000000002137.

  PMID: 28248893 BACKGROUND

• Kaiser MG, Eck JC, Groff MW, Watters WC 3rd, Dailey AT, Resnick DK, Choudhri TF, Sharan A, Wang JC, Mummaneni PV, Dhall SS, Ghogawala Z. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 1: introduction and methodology. J Neurosurg Spine. 2014 Jul;21(1):2-6. doi: 10.3171/2014.4.SPINE14257.

  PMID: 24980578 BACKGROUND

• Costa F, Anania CD, Zileli M, Servadei F, Fornari M. Lumbar Spinal Stenosis: Introduction to the World Federation of Neurosurgical Societies (WFNS) Spine Committee Recommendations. World Neurosurg X. 2020 Mar 10;7:100075. doi: 10.1016/j.wnsx.2020.100075. eCollection 2020 Jul.

  PMID: 32613188 BACKGROUND

• Eck JC, Sharan A, Ghogawala Z, Resnick DK, Watters WC 3rd, Mummaneni PV, Dailey AT, Choudhri TF, Groff MW, Wang JC, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 7: lumbar fusion for intractable low-back pain without stenosis or spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):42-7. doi: 10.3171/2014.4.SPINE14270.

  PMID: 24980584 BACKGROUND

• Wang JC, Dailey AT, Mummaneni PV, Ghogawala Z, Resnick DK, Watters WC 3rd, Groff MW, Choudhri TF, Eck JC, Sharan A, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy. J Neurosurg Spine. 2014 Jul;21(1):48-53. doi: 10.3171/2014.4.SPINE14271.

  PMID: 24980585 BACKGROUND

• Resnick DK, Watters WC 3rd, Sharan A, Mummaneni PV, Dailey AT, Wang JC, Choudhri TF, Eck J, Ghogawala Z, Groff MW, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 9: lumbar fusion for stenosis with spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):54-61. doi: 10.3171/2014.4.SPINE14274.

  PMID: 24980586 BACKGROUND

• Resnick DK, Watters WC 3rd, Mummaneni PV, Dailey AT, Choudhri TF, Eck JC, Sharan A, Groff MW, Wang JC, Ghogawala Z, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: lumbar fusion for stenosis without spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):62-6. doi: 10.3171/2014.4.SPINE14275.

  PMID: 24980587 BACKGROUND

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Fulvio Tartara, MD

  Humanitas Hospital, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Researcher

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 7, 2022
• Study Start: June 1, 2022
• Primary Completion: June 26, 2022
• Study Completion: June 26, 2025
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

IT (8)