NCT04467775

Brief Summary

The parameters of the sagittal balance of the cervical, thoracic and lumbar spine vary according to the types of spino-pelvic organization (types 1-4 according to Roussouly). These parameters have been described as a function of age in previous scientific work without taking into account the pelvic anatomy (pelvic incidence and spino-pelvic organization). This work, carried out within the framework of a round table of the French Society of Spinal Surgery (SFCR), would make it possible to provide a more detailed repository of existing radiographic parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2020

Completed
Last Updated

October 1, 2021

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

July 8, 2020

Last Update Submit

September 30, 2021

Conditions

Keywords

Spinal DeformityLow back painSciaticaCervico brachial neuralgia

Outcome Measures

Primary Outcomes (1)

  • Retrospective study of the radiographic parameters measured by the KEOPS software

    files analysed retrospectily from from January 1, 2014 to December 31, 2019 will be examined

Eligibility Criteria

Age5 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subject having carried out a telecolonne or EOS type X-ray for spinal balance (low back pain, sciatica, cervico-brachial neuralgia, inequality of length of the lower limbs) in spinal surgery consultation

You may qualify if:

  • Minor or major subject aged 5 to 100
  • Subject having carried out a telecolonne or EOS type X-ray for spinal balance (low back pain, sciatica, cervico-brachial neuralgia, inequality of length of the lower limbs) in spinal surgery consultation
  • Subject not having expressed its opposition, after information, to the re-use of its data for the purposes of this research.

You may not qualify if:

  • Subject with surgical history, fractures, osteoporotic packing, vertebral deformation (scoliosis, kyphosis, spondylolisthesis grades 2-5), vertebral osteolysis (spondylodiscitis, tumor or metastasis).
  • Subject who expressed his opposition to participate in the study
  • Subject under guardianship or curatorship
  • Subject under judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie du Rachis

Strasbourg, 67091, France

Location

Related Publications (1)

  • Charles YP, Prost S, Pesenti S, Ilharreborde B, Bauduin E, Laouissat F, Riouallon G, Wolff S, Challier V, Obeid I, Boissiere L, Ferrero E, Solla F, Le Huec JC, Bourret S, Faddoul J, Abi Lahoud GN, Fiere V, Vande Kerckhove M, Campana M, Lebhar J, Giorgi H, Faure A, Sauleau EA, Blondel B; French Spine Surgery Society (SFCR). Variation of cervical sagittal alignment parameters according to gender, pelvic incidence and age. Eur Spine J. 2022 May;31(5):1228-1240. doi: 10.1007/s00586-021-07102-w. Epub 2022 Jan 6.

MeSH Terms

Conditions

Low Back PainSciaticaBrachial Plexus Neuritis

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaBrachial Plexus NeuropathiesNeuritis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 13, 2020

Study Start

January 2, 2020

Primary Completion

October 2, 2020

Study Completion

October 2, 2020

Last Updated

October 1, 2021

Record last verified: 2020-07

Locations