Classification of the Sagittal Profile of the Spine in Asymptomatic Elderly Subjects

NCT03237039 | Unknown DMC

• 1 other identifier: EOS60
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Principal aim The main purpose of the study is to describe the distribution of the sagittal profile in elderly subjects in order to bridge the gap present in this type of screening, evaluated in the literature for adults only (i.e. 160 subjects considered by Roussouly et al. in 2005). This classification assigns an integer value from 1 to 4 in relation to the evaluation of alignment of the lumbar spine and pelvis in the sagittal plane. The population description is therefore divided into four categories. The extension of this classification to elderly can provide useful support for the clinical evaluation and the specific treatment of the elderly patients. Secondary aims The study aims in addition to evaluate the relation between the spine sagittal profile and the objective indexes obtained from the assessment of fall-risk and gait cycle analysis. Accordingly, a subgroup of 40 subjects out of the 160 will be evaluated. This subgroup will consider the subjects older than or equal to 74 years, where the risk of falling is most likely to be expected.

Conditions

Aged; Asymptomatic Condition

Keywords

Roussouly type; spine alignment; fall-risk; gait cycle analysis

Outcome Measures

Primary Outcomes (10)

• Classification of Roussouly type

  This classification assigns an integer value ranging from 1 to 4, in relation to the evaluation of lumbar spine and pelvis alignment in the sagittal plane. It will be acquired to describe subjects' population, and correlations with fall-risk and gait cycle indexes will be checked for.

  Through study completion, an average of 18 months

• Subject's weight

  Subject's weight (kg) will be acquired to describe subjects' population

  Through study completion, an average of 18 months

• Subject's height

  Subject's height (cm) will be acquired to describe subjects' population

  Through study completion, an average of 18 months

• Thoracic kyphosis

  Thoracic kyphosis (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.

  Through study completion, an average of 18 months

• Lumbar lordosis

  Lumbar lordosis (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.

  Through study completion, an average of 18 months

• Pelvic incidence

  Pelvic incidence (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.

  Through study completion, an average of 18 months

• Sacral slope

  Sacral slope (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.

  Through study completion, an average of 18 months

• Pelvic tilt

  Pelvic tilt (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.

  Through study completion, an average of 18 months

• Lateral pelvic inclination

  Lateral pelvic inclination (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.

  Through study completion, an average of 18 months

• Pelvic torsion

  Pelvic torsion (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.

  Through study completion, an average of 18 months

Secondary Outcomes (12)

• Fall-risk score

  Through study completion, an average of 18 months

• Functional forward flexion

  Through study completion, an average of 18 months

• CoP sway area

  Through study completion, an average of 18 months

• Gait analysis: stance phase

  Through study completion, an average of 18 months

• Gait analysis: swing phase

  Through study completion, an average of 18 months

Study Arms (1)

X-ray examination, fall-risk and gait

OTHER

simultaneous acquisition in upright position of two full-body radiographic images, one in the coronal plane and one in the sagittal plane. In addition, 40 out of 160 subjects will undergo fall-risk assessment and gait cycle analysis evaluation.

Radiation: X-ray examination; Other: fall-risk assessment; Other: gait cycle analysis

Interventions

X-ray examination RADIATION

Radiological examination of frontal and lateral planes, simultaneously acquired with low dose X-ray system (EOS system, France) in one single exposition. The evaluation of the radiographic images will be performed by an orthopedic physician.Image processing will be performed by a biomedical engineer through sterEOS proprietary software and will provide the anatomical parameters needed to classify the sagittal profile.

X-ray examination, fall-risk and gait

fall-risk assessment OTHER

This evaluation will be performed after the radiographic scan, in the same day. The fall-risk assessment test will be performed by a biomedical engineer through OAK device (OAK, Khymeia, Italy). The OAK device integrates two force plates and sensory elastic straps applied to pelvis and limbs. This test, which takes approximately twenty minutes, accounts eight consecutive postural equilibrium exercises and provide the automatic detection of subject's postural parameters. At the end of the test, the fall-risk rating is automatically assigned.

X-ray examination, fall-risk and gait

gait cycle analysis OTHER

This assessment will be performed in the same session of fall-risk evaluation. The gait cycle analysis, which takes approximately forty minutes, will be executed by a biomedical engineer. Adhesive passive reflective markers will be placed on the skin according to a protocol suitable to characterize the alignment of lower limbs and trunk. The markers trajectories during walk will be recorded by an eight cameras optoelectronic system (BTS smart-D, Italy). A force platform (Kistler, Switzerland) placed in the middle of the pathway will detect the forces exchanged with the ground. The data analysis will provide the kinematic and kinetic descriptive parameters of gait cycle.

X-ray examination, fall-risk and gait

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than or equal to 60 years
• subscription of informed consent

You may not qualify if:

• Significant painful episodes linked to the spine in the last 2 years
• Early surgical interventions involving the spine
• scoliosis or other spine pathologies (vertebral, neurological, muscular)
• Obesity (BMI\> 30 kg / m2)

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

Marco Brayda-Bruno, MD

Milan, Milan, 20161, Italy

RECRUITING

Related Publications (11)

• Dietrich TJ, Pfirrmann CW, Schwab A, Pankalla K, Buck FM. Comparison of radiation dose, workflow, patient comfort and financial break-even of standard digital radiography and a novel biplanar low-dose X-ray system for upright full-length lower limb and whole spine radiography. Skeletal Radiol. 2013 Jul;42(7):959-67. doi: 10.1007/s00256-013-1600-0. Epub 2013 Mar 28.

  PMID: 23536038 BACKGROUND

• Dreischarf M, Albiol L, Rohlmann A, Pries E, Bashkuev M, Zander T, Duda G, Druschel C, Strube P, Putzier M, Schmidt H. Age-related loss of lumbar spinal lordosis and mobility--a study of 323 asymptomatic volunteers. PLoS One. 2014 Dec 30;9(12):e116186. doi: 10.1371/journal.pone.0116186. eCollection 2014.

  PMID: 25549085 BACKGROUND

• Gelb DE, Lenke LG, Bridwell KH, Blanke K, McEnery KW. An analysis of sagittal spinal alignment in 100 asymptomatic middle and older aged volunteers. Spine (Phila Pa 1976). 1995 Jun 15;20(12):1351-8.

  PMID: 7676332 BACKGROUND

• Hammerberg EM, Wood KB. Sagittal profile of the elderly. J Spinal Disord Tech. 2003 Feb;16(1):44-50. doi: 10.1097/00024720-200302000-00008.

  PMID: 12571484 BACKGROUND

• Jackson RP, Peterson MD, McManus AC, Hales C. Compensatory spinopelvic balance over the hip axis and better reliability in measuring lordosis to the pelvic radius on standing lateral radiographs of adult volunteers and patients. Spine (Phila Pa 1976). 1998 Aug 15;23(16):1750-67. doi: 10.1097/00007632-199808150-00008.

  PMID: 9728376 BACKGROUND

• Jackson RP, Hales C. Congruent spinopelvic alignment on standing lateral radiographs of adult volunteers. Spine (Phila Pa 1976). 2000 Nov 1;25(21):2808-15. doi: 10.1097/00007632-200011010-00014.

  PMID: 11064527 BACKGROUND

• Pellet N, Aunoble S, Meyrat R, Rigal J, Le Huec JC. Sagittal balance parameters influence indications for lumbar disc arthroplasty or ALIF. Eur Spine J. 2011 Sep;20 Suppl 5(Suppl 5):647-62. doi: 10.1007/s00586-011-1933-0. Epub 2011 Aug 16.

  PMID: 21845396 BACKGROUND

• Roussouly P, Gollogly S, Berthonnaud E, Dimnet J. Classification of the normal variation in the sagittal alignment of the human lumbar spine and pelvis in the standing position. Spine (Phila Pa 1976). 2005 Feb 1;30(3):346-53. doi: 10.1097/01.brs.0000152379.54463.65.

  PMID: 15682018 BACKGROUND

• Shah DJ, Sachs RK, Wilson DJ. Radiation-induced cancer: a modern view. Br J Radiol. 2012 Dec;85(1020):e1166-73. doi: 10.1259/bjr/25026140.

  PMID: 23175483 BACKGROUND

• Stagnara P, De Mauroy JC, Dran G, Gonon GP, Costanzo G, Dimnet J, Pasquet A. Reciprocal angulation of vertebral bodies in a sagittal plane: approach to references for the evaluation of kyphosis and lordosis. Spine (Phila Pa 1976). 1982 Jul-Aug;7(4):335-42. doi: 10.1097/00007632-198207000-00003.

  PMID: 7135066 BACKGROUND

• Vedantam R, Lenke LG, Keeney JA, Bridwell KH. Comparison of standing sagittal spinal alignment in asymptomatic adolescents and adults. Spine (Phila Pa 1976). 1998 Jan 15;23(2):211-5. doi: 10.1097/00007632-199801150-00012.

  PMID: 9474728 BACKGROUND

MeSH Terms

Conditions

Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Brayda-Bruno, MD

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tito Bassani, PhD

CONTACT

+390266214939; tito.bassani@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: symptomatic elderly subjects

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: August 2, 2017
• Study Start: June 14, 2017
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: August 2, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)