Influence of life-style factors on the development of the immune system and allergies in East and West Germany

Overview
Related items

The LISA study is an ongoing, long-term, population-based prospective birth cohort study comprising 3094 children from four regions of Germany (Munich, Leipzig, Wesel, Bad Honnef). The aims of the LISA study are to monitor the development and natural course of atopic diseases and to investigate the influence of life-style and environmental factors. The study further collects information on mental well-being, lung function, nutrition, body composition and physical activity, contributing to a better understanding of childhood allergies, growth and genetics.

SEEK ID: https://ldh-dzkj.vm.gwdguser.de/projects/4

Public web page: Not specified

Organisms: No Organisms specified

DZKJ, Standort Göttingen PALs: No PALs for this Project

Project created: 10th Jul 2026

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : nfdi4health-187

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : Influence of life-style factors on the development of the immune system and allergies in East and West Germany
Language of the title/name : English

Title/name : LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
Language of the title/name : English

Acronym(s) of the Project

Acronym : LISA
Language of the acronym : English

Description(s) of the Project

Description : The LISA study is an ongoing, long-term, population-based prospective birth cohort study comprising 3094 children from four regions of Germany (Munich, Leipzig, Wesel, Bad Honnef). The aims of the LISA study are to monitor the development and natural course of atopic diseases and to investigate the influence of life-style and environmental factors. The study further collects information on mental well-being, lung function, nutrition, body composition and physical activity, contributing to a better understanding of childhood allergies, growth and genetics.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Infant Health

Keyword(*) : Child

Keyword(*) : Adolescent

Keyword(*) : Allergy and Immunology

Keyword(*) : Health

Keyword(*) : Environmental Exposure

Keyword(*) : Lifestyle Factors

Keyword(*) : Genetics

Keyword(*) : Traffic-Related Pollution

Keyword(*) : Atopy (finding)

Keyword(*) : Diet, Food and Nutrition

Keyword(*) : Body Weight

Keyword(*) : Physical activity (observable entity)

Keyword(*) : Pathological Conditions, Signs and Symptoms

Keyword(*) : Not specified

Keyword(*) : Not specified

Keyword(*) : Not specified

Keyword(*) : Not specified

Keyword(*) : Not specified

Keyword(*) : Not specified

Keyword(*) : Not specified

Keyword(*) : Not specified

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Language(s) of the project : German

Web page of the project : https://www.helmholtz-munich.de/en/epi/cohort/lisa

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : BACKBONE
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Marie
Family name(s)(*) : Standl
Digital identifier(s)
Identifier(*) : 0000-0002-5345-2049
Scheme(*) : ORCID
Email address : marie.standl@helmholtz-munich.de
Phone number : +49 89 3187 2952
Organisation(s) associated with the contributor
Name(*) : Helmholtz Zentrum München, Institute of Epidemiology
Address : Ingolstädter Landstraße 1, D-85764 Neuherberg
Web page : https://www.helmholtz-munich.de/en/epi
Digital identifier(s)
Identifier(*) : 00cfam450
Scheme(*) : ROR

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Contact
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Contact person
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Vincent
Family name(s)(*) : Pointillart
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : lisa@helmholtz-muenchen.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Helmholtz Zentrum München, Institute of Epidemiology
Address : Ingolstädter Landstraße 1, D-85764 Neuherberg
Web page : https://www.helmholtz-munich.de/en/epi
Digital identifier(s)
Identifier(*) : 00cfam450
Scheme(*) : ROR
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Contact
Given name(*) : Aurélie
Family name(s)(*) : Affret
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : aat@backbone.pro
Phone number : 0033686114973
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Contact
Given name(*) : Nazanine
Family name(s)(*) : Sahami
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : nsi@backbone.pro
Phone number : 0033646592539
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Creator/Author
Given name(*) : Vincent
Family name(s)(*) : Pointillart
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Not specified
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT04631133

Type of the registry(*) : Other
Identifier(*) : DHF-111-PMCF1

Characteristics of the Project

Is it an interventional or non-interventional Project? : Non-interventional
Specification of the type of the Project
Interventional Project type : []
Non-interventional Project type : Birth cohort
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Allergic disorder
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/781474001
Primary health condition or disease name(*) : Atopic dermatitis
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/24079001
Primary health condition or disease name(*) : Asthma
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/195967001
Primary health condition or disease name(*) : Allergic rhinitis
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/61582004
Primary health condition or disease name(*) : Obesity
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/414916001
Primary health condition or disease name(*) : Mental disorder
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/74732009
Primary health condition or disease name(*) : General diet
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/41449007
Primary health condition or disease name(*) : Physical activity
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/68130003
Primary health condition or disease name(*) : Air pollution
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/102413006
Primary health condition or disease name(*) : Local environment and neighborhood details
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/224153006
Primary health condition or disease name(*) : Not specified
Terminology/classification(*) : Not specified
Code of the health condition or disease : Not specified
Primary health condition or disease name(*) : Not specified
Terminology/classification(*) : Not specified
Code of the health condition or disease : Not specified
Primary health condition or disease name(*) : Not specified
Terminology/classification(*) : Not specified
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the blood or blood-forming organs and certain disorders involving the immune mechanism (III), Endocrine, nutritional and metabolic diseases (IV), Mental and behavioural disorders (V), Diseases of the nervous system (VI), Diseases of the respiratory system (X), Diseases of the digestive system (XI), Diseases of the skin and subcutaneous tissue (XII), Factors influencing health status and contact with health services (XXI)
On which diseases or conditions were the data collected? : []
Collects mortality data? : No
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Ongoing (III): Recruitment completed, but data collection ongoing
Participants enrolled by invitation? : Not specified
Start date : 11 November 1997
End date : 31 December 2028
Mono- or multicentric? : Multicentric
Number of centers : 4
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : Not specified
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Years
Eligible gender : Male, Female, Diverse
Inclusion criteria : Healthy and full-term newborns and a birth weight of more than 2,500 g
Exclusion criteria : Newborns whose mothers suffered from an immunologically relevant chronic disease, like diabetes, HIV, or autoimmune disease, or who were drug or alcohol addicted, were excluded. Children whose parents were not sufficiently capable of the German language were also not included in the study. Furthermore, newborns were excluded if their families lived more than 50 km from the city center or planned to move away from the study region.
Population of the Project(*)
Coverage : Not specified
Country(ies) : Germany
Region(s) and/or city(ies) : Munich, Leipzig, Wesel, Bad Honnef
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : LISA implant survival rate 2 years after surgery defined as successful LISA implantation without reoperation, revision, or removal/ ODI change between pre-operative assessment and 2 years follow-up (FU)/ 1ary endpoint will also be evaluated at 1-year FU
Description of the outcome measure : Not specified
Type of the outcome measure : Primary
Time point(s) of assessment : 24-months post surgery; 12-months post surgery
Name of the outcome measure(*) : LISA implant survival rate defined as successful LISA implantation without reoperation, revision, or removal
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery; 6-months post surgery; 48-months post surgery; 72-months post surgery
Name of the outcome measure(*) : Duration of the surgery
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Perioperative
Name of the outcome measure(*) : Duration of the implant placement
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Perioperative
Name of the outcome measure(*) : Amount of blood loss
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Perioperative
Name of the outcome measure(*) : Scoring of the surgical technique assessed by a 14-items question
Description of the outcome measure : 14 steps of the surgical technique are rated from 0 to 7; 0 being considered as very easy and 7 being considered as very difficult
Type of the outcome measure : Secondary
Time point(s) of assessment : Perioperative
Name of the outcome measure(*) : Number of hospitalization days
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery
Name of the outcome measure(*) : Time to return to normal activity (working) depending on the patient's profession (blue collar, white collar)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery
Name of the outcome measure(*) : Number of patients with reoperations/ revision or removal at the operative level or on adjacent levels relating to the device and not the pathology/ implant breakage (polyester band rupture)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Name of the outcome measure(*) : Number of patients with migration or rupture of any implant component (Polyester band loose)/ major unanticipated device related complications/ post-operative scapular pain/ recurrence of the initial symptoms/ degeneration of the adjacent segments
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Name of the outcome measure(*) : Number of patients with superficial infection/ dural injury/ bone fracture or bone erosion anywhere implant is in contact with the anatomy/ Any other procedure or device related adverse events
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Name of the outcome measure(*) : Oswestry Disability Index (ODI) to assess limitations of various activities of daily living.
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Pre-operative
Name of the outcome measure(*) : Change from baseline in Oswestry Disability Index at 3 months
Description of the outcome measure : Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery
Name of the outcome measure(*) : Change from baseline in Oswestry Disability Index at 6 months
Description of the outcome measure : Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Type of the outcome measure : Secondary
Time point(s) of assessment : 6-months post surgery
Name of the outcome measure(*) : Change from baseline in Oswestry Disability Index at 48 months
Description of the outcome measure : Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Type of the outcome measure : Secondary
Time point(s) of assessment : 48-months post surgery
Name of the outcome measure(*) : Change from baseline in Oswestry Disability Index at 72 months
Description of the outcome measure : Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Type of the outcome measure : Secondary
Time point(s) of assessment : 72-months post surgery
Name of the outcome measure(*) : Visual Analogue Scale (VAS) to assess back pain
Description of the outcome measure : Patients rate their back pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"
Type of the outcome measure : Secondary
Time point(s) of assessment : Pre-operative
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for back pain at 3 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for back pain at 6 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 6-months post surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for back pain at 12 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 12-months post surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for back pain at 24 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 24-months post surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for back pain at 48 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 48-months post surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for back pain at 72 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 72-months post surgery
Name of the outcome measure(*) : Visual Analogue Scale (VAS) to assess right leg pain
Description of the outcome measure : Patients rate their right leg pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"
Type of the outcome measure : Secondary
Time point(s) of assessment : Pre-operative
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 3 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 6 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 6-months post surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 12 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 12-months post surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 24 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 24-months post surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 48 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 48-months post surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 72 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 72-months post surgery
Name of the outcome measure(*) : Visual Analogue Scale (VAS) to assess left leg pain
Description of the outcome measure : Patients rate their left leg pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"
Type of the outcome measure : Secondary
Time point(s) of assessment : Pre-operative
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 3 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post-surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 6 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 6-months post-surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 12 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 12-months post-surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 24 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 24-months post-surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 48 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 48-months post-surgery
Name of the outcome measure(*) : Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 72 months
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : 72-months post-surgery
Name of the outcome measure(*) : Patient satisfaction with treatment assessed by a 4-items question
Description of the outcome measure : Patients rate their satisfaction with treatment choosing one of the following options: Very satisfied/Somewhat satisfied/Somewhat dissatisfied/Very Dissatisfied
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Name of the outcome measure(*) : Patient's recommendation for treatment assessed by a 4-items question
Description of the outcome measure : Patient rate wether they would recommend the same treatment to a friend with the same condition, choosing one of the following options: Definitely YES/Probably YES/ Probably NO/ Definitely NOT
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Name of the outcome measure(*) : Patient's opinion related to the treatment assessed by a 6-items question
Description of the outcome measure : Patient rate how effective was the treatment in eliminating the symptoms choosing one of the following options: "very effective, relieved all the symptoms", "moderately effective", "somewhat effective", "somewhat ineffective", "moderately ineffective", "very ineffective, did not relieve or lessen the symptoms"
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Name of the outcome measure(*) : Surgeon surgery outcome assessed by a 4-items question
Description of the outcome measure : Surgeons rate the result of the surgery, choosing one of the following options: Excellent; Good; Fair; Poor
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Name of the outcome measure(*) : Segmental joints condition assessed thanks to radiological results (if available)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Pre-operative
Name of the outcome measure(*) : Change from baseline in segmental joints condition at 3-months
Description of the outcome measure : Segmental joints condition are assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery
Name of the outcome measure(*) : Change from baseline in segmental joints condition at 6-months
Description of the outcome measure : Segmental joints condition are assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 6-months post surgery
Name of the outcome measure(*) : Change from baseline in segmental joints condition at 12-months
Description of the outcome measure : Segmental joints condition are assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 12-months post surgery
Name of the outcome measure(*) : Change from baseline in segmental joints condition at 24-months
Description of the outcome measure : Segmental joints condition are assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 24-months post surgery
Name of the outcome measure(*) : Change from baseline in segmental joints condition at 48-months
Description of the outcome measure : Segmental joints condition are assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 48-months post surgery
Name of the outcome measure(*) : Change from baseline in segmental joints condition at 72-months
Description of the outcome measure : Segmental joints condition are assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 72-months post surgery
Name of the outcome measure(*) : Narrowness of the spinal canal assessed thanks to radiological results (if available)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Pre-operative
Name of the outcome measure(*) : Change from baseline in narrowness of the spinal canal at 3 months
Description of the outcome measure : Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post surgery
Name of the outcome measure(*) : Change from baseline in narrowness of the spinal canal at 6 months
Description of the outcome measure : Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 6-months post surgery
Name of the outcome measure(*) : Change from baseline in narrowness of the spinal canal at 12 months
Description of the outcome measure : Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 12-months post surgery
Name of the outcome measure(*) : Change from baseline in narrowness of the spinal canal at 24 months
Description of the outcome measure : Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 24-months post surgery
Name of the outcome measure(*) : Change from baseline in narrowness of the spinal canal at 48 months
Description of the outcome measure : Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 48-months post surgery
Name of the outcome measure(*) : Change from baseline in narrowness of the spinal canal at 72 months
Description of the outcome measure : Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 72-months post surgery
Name of the outcome measure(*) : Foraminal compression assessed thanks to radiological results (if available)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Pre-operative
Name of the outcome measure(*) : Change from baseline in foraminal compression at 3 months
Description of the outcome measure : Foraminal compression is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 3-months post-surgery
Name of the outcome measure(*) : Change from baseline in foraminal compression at 6 months
Description of the outcome measure : Foraminal compression is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 6-months post-surgery
Name of the outcome measure(*) : Change from baseline in foraminal compression at 12 months
Description of the outcome measure : Foraminal compression is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 12-months post-surgery
Name of the outcome measure(*) : Change from baseline in foraminal compression at 24 months
Description of the outcome measure : Foraminal compression is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 24-months post-surgery
Name of the outcome measure(*) : Change from baseline in foraminal compression at 48 months
Description of the outcome measure : Foraminal compression is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 48-months post-surgery
Name of the outcome measure(*) : Change from baseline in foraminal compression at 72 months
Description of the outcome measure : Foraminal compression is assessed thanks to radiological results (if available)
Type of the outcome measure : Secondary
Time point(s) of assessment : 72-months post-surgery
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Due to data protection reasons, the datasets generated and/or analyzed within the LISA study cannot be made publicly available. The release of the data to interested researchers has to be consistent with the consent given by the LISA study participants. Ethical approval might be obtained for the release and a data transfer agreement from the legal department of the Helmholtz Zentrum München must be accepted.
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : Prospective
Target follow-up duration of the Project
Target follow-up duration(*) : 25
Unit of time(*) : Years
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : Samples with DNA, Samples without DNA
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

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