AgedEOS60NCT03237039
Classification of the Sagittal Profile of the Spine in Asymptomatic Elderly Subjects
A study testing X-ray examination, fall-risk assessment and gait cycle analysis in people with Aged and Asymptomatic Condition, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged, Asymptomatic Condition
- What is being tested?
- X-ray examination, fall-risk assessment and gait cycle analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jun 2017to 3 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- older than or equal to 60 years
- subscription of informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Marco Brayda-Bruno, MD
Milan, Milan, 20161
Marco Brayda-Bruno, MD, +390266214939, marco.brayda@spinecaregroup.it
About this study
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.
Read the detailed description
Introduction:
The classification of spine sagittal profile can be an essential prediction factor for the specific prevention and treatment of patient's pathologies. Despite high variability, sagittal alignment can be accurately measured by radiographic examination and is fully replicable. To this regard, a classification of the lumbar profile and pelvis in the sagittal plane was proposed by Roussouly et al. Specifically, four different typologies can be recognized. These typologies classify the profile of the lumbar curve and are directly related to the quantification of the pelvic inclination. The study by Roussouly et al. examined 160 asymptomatic subjects aged between 18 and 45 years and confirmed the high inter-individual variability of the sagittal profile. Unfortunately, this classification has not been extended to elderly. In this regard, it has been shown that peculiar changes in the sagittal profile are particularly evident in aging, such as the advancement of the average sagittal axis and the tendency to decrease of the degree of lumbar lordosis.
According to that, extending the classification of the spine sagittal alignment in elderly results of prime importance. Furthermore, extending this classification will also provide useful information supporting the clinical evaluation and the specific treatment of elderly patients (e.g. better understanding the association between spine alignment and the development of degenerative alterations). In addition to this primary objective, this study aims to assess the relation between postural imbalance (due to alterations of the sagittal profile) and motor functionality in elderly. A subgroup of the enrolled subjects, equal to one quarter of the total size, will undergo fall-risk assessment and gait cycle analysis. This subgroup will account subjects older than or equal to 74 years, where the risk of falling is more likely to occur. The objective indices obtained from these analyses will be put in relation with the classification of the spine sagittal profile.
Aims of the study:
The primary aim of this study is to classify the spine sagittal profile in elderly asymptomatic subjects (older than or equal to 60 years) through the semi-automatic analysis of low dose radiographic images obtained through a validated radiographic system (EOS Imaging System, France). The study will evaluate 160 subjects, at least 40 of whom will have an age greater than or equal to 74 years. According to Roussouly et al., the classification of the spine alignment will assign an integer value ranging from 1 to 4, in relation to the evaluation of the lumbar spine and pelvis in the sagittal plane. Secondary aim of the study will be to investigate the relation between the classification of spine sagittal profile and the objective indexes characterizing the fall-risk and the gait cycle analysis. This assessment will take into account the subgroup of 40 subjects aged 74 years or more.
Radiographic examination:
The radiographic examination will be performed with the EOS low-dose X-ray radiation system by a radiology technician. The examination, which will take about 10 seconds, will allow the simultaneous acquisition in upright position of two full-body radiographic images, one in the coronal plane and one in the sagittal plane. 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.
Assessment of fall-risk:
This evaluation will be performed after the radiographic examination, in the same session. 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.
Gait cycle analysis:
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.
Statistical analysis:
The total sample size was chosen considering the classificatory purpose of the present study and its descriptive and non-comparative intent. It was therefore considered as appropriate to match the number of 160 subjects evaluated in previous study to classify the spine sagittal alignment in adult subjects. Concerning the secondary aim of the study, the correlation between the Roussouly type (identifying the spine sagittal alignment) and the indexes characterizing fall-risk and gait cycle will be assessed. The significance of the Pearson correlation coefficient or of Spearman correlation coefficient, in case of non-Gaussian data, will be tested according to two-tailed t-test or permutation distribution test, respectively. Statistical significance will be considered at p <0.05 level. To this regard, the sample size requested to guarantee the significance (with α = 0.05 and statistical power = 95%) of a correlation value defined as 'strong' (not less than 0.6, in absolute value), is equal to 30. The number of 40 subjects planned for the secondary aim thus fulfills the requirements for the correlation analysis.
- Conditions
- Aged, Asymptomatic Condition
- Being tested
- X-ray examination, fall-risk assessment, gait cycle analysis
- Keywords
- Roussouly type, spine alignment, fall-risk, gait cycle analysis
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-ray examinationRadiation
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.
fall-risk assessmentOther
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.
gait cycle analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: X-ray examination; Other: fall-risk assessment; Other: gait cycle analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 18 months
Subject's weight
Subject's weight (kg) will be acquired to describe subjects' population
Measured: Through study completion, an average of 18 months
Subject's height
Subject's height (cm) will be acquired to describe subjects' population
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 18 months
Secondary outcomes (12)
Fall-risk score
Evaluation of the fall-risk with the OAK device (OAK, Khymeia, Italy). The device automatically evaluates the fall-risk score, an integer value ranging from 0 to 24, where 0 indicates maximum risk and 24 the minimum.
Measured: Through study completion, an average of 18 months
Functional forward flexion
Functional forward flexion (cm) will be automatically computed by the OAK device.
Measured: Through study completion, an average of 18 months
CoP sway area
Sway area of the center of pressure (cm2) will be automatically computed by the OAK device.
Measured: Through study completion, an average of 18 months
Gait analysis: stance phase
Stance phase (% of total gait cycle time) will be evaluated for both the right and left legs.
Measured: Through study completion, an average of 18 months
Gait analysis: swing phase
Swing phase (% of total gait cycle time) will be evaluated for both the right and left legs.
Measured: Through study completion, an average of 18 months
Gait analysis: stride length
Stride length (m) will be evaluated for both the right and left legs.
Measured: Through study completion, an average of 18 months
Gait analysis: average walking speed
Average walking speed (m/s).
Measured: Through study completion, an average of 18 months
Gait analysis: average step cadence
Average step cadence (steps/min)
Measured: Through study completion, an average of 18 months
Gait analysis: maximum hip flexion
Maximum hip flexion (°) will be evaluated for both the right and left hips.
Measured: Through study completion, an average of 18 months
Gait analysis: maximum hip extension
Maximum hip extension (°) will be evaluated for both the right and left hips.
Measured: Through study completion, an average of 18 months
Gait analysis: maximum hip flexion moment
Maximum hip flexion moment (Nm) will be evaluated for both the right and left hips.
Measured: Through study completion, an average of 18 months
Gait analysis: maximum hip extension moment
Maximum hip extension moment (Nm) will be evaluated for both the right and left hips.
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start14 Jun 2017
- Primary completion3 Apr 2019 (estimated)
- Study completion3 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AgedStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- symptomatic elderly subjects
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Brayda-Bruno, MD, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237039
- Sponsor's protocol ID
- EOS60
- Acronym
- EOS60
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23536038Dreischarf 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.
PubMed 25549085Gelb 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.
PubMed 7676332Hammerberg EM, Wood KB. Sagittal profile of the elderly. J Spinal Disord Tech. 2003 Feb;16(1):44-50. doi: 10.1097/00024720-200302000-00008.
PubMed 12571484Jackson 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.
PubMed 9728376Jackson 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.
PubMed 11064527Pellet 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.
PubMed 21845396Roussouly 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.
PubMed 15682018Shah 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.
PubMed 23175483Stagnara 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.
PubMed 7135066Vedantam 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.
PubMed 9474728
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of the Sagittal Profile of the Spine in Asymptomatic Elderly Subjects
- ClinicalTrials.gov ID
- NCT03237039
- Acronym / sponsor ID
- EOS60 / EOS60
- Conditions
- Aged, Asymptomatic Condition
- Keywords
- Roussouly type, spine alignment, fall-risk, gait cycle analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 3 Apr 2019 (estimated)
- Study completion
- 3 Apr 2019 (estimated)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction:
The classification of spine sagittal profile can be an essential prediction factor for the specific prevention and treatment of patient's pathologies. Despite high variability, sagittal alignment can be accurately measured by radiographic examination and is fully replicable. To this regard, a classification of the lumbar profile and pelvis in the sagittal plane was proposed by Roussouly et al. Specifically, four different typologies can be recognized. These typologies classify the profile of the lumbar curve and are directly related to the quantification of the pelvic inclination. The study by Roussouly et al. examined 160 asymptomatic subjects aged between 18 and 45 years and confirmed the high inter-individual variability of the sagittal profile. Unfortunately, this classification has not been extended to elderly. In this regard, it has been shown that peculiar changes in the sagittal profile are particularly evident in aging, such as the advancement of the average sagittal axis and the tendency to decrease of the degree of lumbar lordosis.
According to that, extending the classification of the spine sagittal alignment in elderly results of prime importance. Furthermore, extending this classification will also provide useful information supporting the clinical evaluation and the specific treatment of elderly patients (e.g. better understanding the association between spine alignment and the development of degenerative alterations). In addition to this primary objective, this study aims to assess the relation between postural imbalance (due to alterations of the sagittal profile) and motor functionality in elderly. A subgroup of the enrolled subjects, equal to one quarter of the total size, will undergo fall-risk assessment and gait cycle analysis. This subgroup will account subjects older than or equal to 74 years, where the risk of falling is more likely to occur. The objective indices obtained from these analyses will be put in relation with the classification of the spine sagittal profile.
Aims of the study:
The primary aim of this study is to classify the spine sagittal profile in elderly asymptomatic subjects (older than or equal to 60 years) through the semi-automatic analysis of low dose radiographic images obtained through a validated radiographic system (EOS Imaging System, France). The study will evaluate 160 subjects, at least 40 of whom will have an age greater than or equal to 74 years. According to Roussouly et al., the classification of the spine alignment will assign an integer value ranging from 1 to 4, in relation to the evaluation of the lumbar spine and pelvis in the sagittal plane. Secondary aim of the study will be to investigate the relation between the classification of spine sagittal profile and the objective indexes characterizing the fall-risk and the gait cycle analysis. This assessment will take into account the subgroup of 40 subjects aged 74 years or more.
Radiographic examination:
The radiographic examination will be performed with the EOS low-dose X-ray radiation system by a radiology technician. The examination, which will take about 10 seconds, will allow the simultaneous acquisition in upright position of two full-body radiographic images, one in the coronal plane and one in the sagittal plane. 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.
Assessment of fall-risk:
This evaluation will be performed after the radiographic examination, in the same session. 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.
Gait cycle analysis:
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.
Statistical analysis:
The total sample size was chosen considering the classificatory purpose of the present study and its descriptive and non-comparative intent. It was therefore considered as appropriate to match the number of 160 subjects evaluated in previous study to classify the spine sagittal alignment in adult subjects. Concerning the secondary aim of the study, the correlation between the Roussouly type (identifying the spine sagittal alignment) and the indexes characterizing fall-risk and gait cycle will be assessed. The significance of the Pearson correlation coefficient or of Spearman correlation coefficient, in case of non-Gaussian data, will be tested according to two-tailed t-test or permutation distribution test, respectively. Statistical significance will be considered at p <0.05 level. To this regard, the sample size requested to guarantee the significance (with α = 0.05 and statistical power = 95%) of a correlation value defined as 'strong' (not less than 0.6, in absolute value), is equal to 30. The number of 40 subjects planned for the secondary aim thus fulfills the requirements for the correlation analysis.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- symptomatic elderly subjects
| Arm | Type | Receives |
|---|---|---|
| X-ray examination, fall-risk and gait | Other | Radiation: X-ray examination, Other: fall-risk assessment, Other: gait cycle analysissimultaneous 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- older than or equal to 60 years
- subscription of informed consent
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-ray examinationRadiological 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. | Radiation | X-ray examination, fall-risk and gait |
| fall-risk assessmentThis 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. | Other | X-ray examination, fall-risk and gait |
| gait cycle analysisThis 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. | Other | X-ray examination, fall-risk and gait |
Primary outcome
Classification of Roussouly type
Time frame: Through study completion, an average of 18 months
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.
Subject's weight
Time frame: Through study completion, an average of 18 months
Subject's weight (kg) will be acquired to describe subjects' population
Subject's height
Time frame: Through study completion, an average of 18 months
Subject's height (cm) will be acquired to describe subjects' population
Thoracic kyphosis
Time frame: Through study completion, an average of 18 months
Thoracic kyphosis (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Lumbar lordosis
Time frame: Through study completion, an average of 18 months
Lumbar lordosis (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Pelvic incidence
Time frame: Through study completion, an average of 18 months
Pelvic incidence (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Sacral slope
Time frame: Through study completion, an average of 18 months
Sacral slope (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Pelvic tilt
Time frame: Through study completion, an average of 18 months
Pelvic tilt (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Lateral pelvic inclination
Time frame: Through study completion, an average of 18 months
Lateral pelvic inclination (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
Pelvic torsion
Time frame: Through study completion, an average of 18 months
Pelvic torsion (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
12 secondary outcomes
Fall-risk score
Time frame: Through study completion, an average of 18 months
Functional forward flexion
Time frame: Through study completion, an average of 18 months
CoP sway area
Time frame: Through study completion, an average of 18 months
Gait analysis: stance phase
Time frame: Through study completion, an average of 18 months
Gait analysis: swing phase
Time frame: Through study completion, an average of 18 months
Gait analysis: stride length
Time frame: Through study completion, an average of 18 months
Gait analysis: average walking speed
Time frame: Through study completion, an average of 18 months
Gait analysis: average step cadence
Time frame: Through study completion, an average of 18 months
Gait analysis: maximum hip flexion
Time frame: Through study completion, an average of 18 months
Gait analysis: maximum hip extension
Time frame: Through study completion, an average of 18 months
Gait analysis: maximum hip flexion moment
Time frame: Through study completion, an average of 18 months
Gait analysis: maximum hip extension moment
Time frame: Through study completion, an average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Background: PubMed 23536038Dietrich 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.
- Background: PubMed 25549085Dreischarf 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.
- Background: PubMed 7676332Gelb 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.
- Background: PubMed 12571484Hammerberg EM, Wood KB. Sagittal profile of the elderly. J Spinal Disord Tech. 2003 Feb;16(1):44-50. doi: 10.1097/00024720-200302000-00008.
- Background: PubMed 9728376Jackson 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.
- Background: PubMed 11064527Jackson 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.
- Background: PubMed 21845396Pellet 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.
- Background: PubMed 15682018Roussouly 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.
- Background: PubMed 23175483Shah 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.
- Background: PubMed 7135066Stagnara 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.
- Background: PubMed 9474728Vedantam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Brayda-Bruno, MD principal investigator
IRCCS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X-ray examination, fall-risk assessment and gait cycle analysis in people with Aged and Asymptomatic Condition, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tito Bassani, PhD (+390266214939, tito.bassani@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of Roussouly type (time frame: Through study completion, an average of 18 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03237039, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.