Distal Femoral Musculoskeletal TumorsMP-GPNCT05202873
Analysis of Spatiotemporal Gait Parameters in Patients With Megaprosthesis.
An observational study of Distal Femoral Musculoskeletal Tumors and Megaprosthesis, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
The main objective of the study is to evaluate spatiotemporal parameters of gait in tumoral patients with megaprosthesis of the distal femur. Read more about this study
- Who is it for?
- Ages 16 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Femoral Musculoskeletal Tumors, Megaprosthesis
- What is being tested?
- Gait analysis
- How many people
- 79 participants
- Where
- 1 siteSpain
- Study dates
- 8 Feb 2018to 1 Nov 2024
- Phase
- Observational
- 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 16 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who underwent a megaprosthesis of the lower limb (distal femur) at Hospital La Fe by the orthopedic surgery and traumatology service, due to a tumor cause
Who may be able to join
- Megaprosthesis of the distal femur
- Tumor cause
- Surgery at Hospital la Fe.
- Traditional stem or biological ossteointegration system
- Minimum postoperative follow-up period of 3 months
Who cannot join
- Neurological alterations prior to the intervention that affect the lower limbs or general movement.
- Patient incapable of ambulation due to progression of his/her pathology
- Patient at home with palliative treatment for advanced tumor disease
- Any ipsilateral or contralateral prosthesis.
- Infectious or traumatic cause
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Spatiotemporal Gait Parameters in Patients With Distal Femoral Megaprosthesis and Healthy Subjects Using an Inertial Measurement Unit (IMU)
The main objective of the study is to evaluate spatiotemporal parameters of gait in tumoral patients with megaprosthesis of the distal femur.
Read the detailed description
Patients with distal femoral prostheses treated at La Fe Hospital in Valencia were evaluated and compared with healthy controls. A radiographic study was conducted in cases using telemetric imaging to assess the percentage of remaining bone and the long length limb discrepancy following surgical intervention. Additionally, a gait analysis was performed using the BTS device to obtain objective gait parameters. The gait assessment was conducted with a non-invasive portable device, the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy), which was placed at the S1 level to collect spatio-temporal gait data. The data were analyzed in relation to the values in healthy patients.
- Being tested
- Gait analysis
- Keywords
- Gait Analysis, Case-control study, Megaprosthesis, Orthopedic oncology, Musculoskeletal tumour, Distal femur, Inertial Measurement Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisDiagnostic test
Gait assessment will be performed using a non-invasive device. It is the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy). The spatiotemporal variables of gait will be studied from the Walk+ protocol, in which the participant navigates a 7-meter hallway six times, completing three round trips with necessary turns at each end to change direction.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with distal femoral megaprosthesis due to musculoskeletal tumor Receives: Diagnostic Test: Gait analysis | |
| Control | Healthy subjects Receives: Diagnostic Test: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antero-posterior acceleration symmetry index
This metric serves as a quantifiable measure of the symmetry exhibited in movements along the antero-posterior axis, thereby illustrating the equilibrium and coordination inherent in the body's kinetic activities.
Measured: 3 months
Stance Phase
Refers to the portion of the gait cycle during which a foot is in contact with the ground. It begins with the initial contact (heel strike) and ends when the same foot leaves the ground (toe-off). The stance phase is a critical component of walking and running, contributing to balance, propulsion, and weight-bearing.
Measured as a percentage of the total gait cycle, 60% of the cycle in typical walking.
Measured: 3 months
Swing Phase
Refers to the portion of the gait cycle during which a foot is not in contact with the ground. It begins when the foot lifts off the ground (toe-off) and ends when the same foot makes contact again (heel strike). The swing phase allows the leg to advance forward and position itself for the next step. Measured as a percentage of the total gait cycle, 40% of the cycle in normal walking.
Measured: 3 months
Gait Quality Index
The stance-swing phase ratio
Measured: 3 months
First Double support phase
Refers to the portion of the gait cycle during walking when both feet are in contact with the ground simultaneously. It occurs at the beginning of the stance phase for one leg, immediately after heel strike, and ends when the opposite foot lifts off (toe-off). This phase contributes to stability during gait. Measured as a percentage of the total gait cycle.
Measured: 3 months
Single Support Phase
Refers to the portion of the gait cycle during which only one foot is in contact with the ground bearing the entire body weight while the other foot is in the swing phase. It is essential for maintaining balance and forward progression during walking. Measured as a percentage of the total gait cycle.
Measured: 3 months
Propulsion Index
This measures the subject's ability to propel the centre of mass forward during the single support stance phase.
Measured: 3 months
Pelvic tilt range
Refers to the total angular movement of the pelvis in the sagittal plane during a specific activity, such as walking. It represents the difference between the maximum anterior tilt (forward rotation) and maximum posterior tilt (backward rotation) of the pelvis within a given cycle. Measured in degrees (°) to quantify the extent of pelvic rotation.
Measured: 3 months
Pelvic obliquity range
Refers to the total angular movement of the pelvis in the coronal (frontal) plane during activities such as walking. It describes the difference between the maximum upward tilt (hip hike) and maximum downward tilt (hip drop) of one side of the pelvis relative to the opposite side. Measured in degrees (°) to quantify the range of motion.
Measured: 3 months
Pelvic rotation range
Refers to the total angular movement of the pelvis in the transverse (horizontal) plane during activities such as walking. It represents the difference between the maximum forward rotation and maximum backward rotation of the pelvis around a vertical axis within a given cycle. Measured in degrees (°) to quantify the range of rotational motion.
Measured: 3 months
Pelvic symmetry tilt index
Is a quantitative measure that evaluates the symmetry of pelvic tilt during movement. It assesses the degree of deviation in pelvic tilt between the left and right sides in the sagittal plane, providing insight into potential imbalances or asymmetries. Expressed as a percentage (%) to indicate the level of symmetry.
Measured: 3 months
Pelvic symmetry obliquity index
Is a quantitative measure used to evaluate the symmetry of pelvic obliquity during movement. It quantifies the degree of deviation in upward or downward tilt of the pelvis on one side compared to the other in the coronal (frontal) plane, helping to identify potential imbalances or asymmetries. Expressed as a percentage (%) to represent the level of symmetry.
Measured: 3 months
Pelvic symmetry rotation index
Is a quantitative measure used to assess the symmetry of pelvic rotation during movement, particularly in the transverse (horizontal) plane. It calculates the difference in rotational movement between the left and right sides of the pelvis, helping to identify any imbalances or asymmetries in pelvic motion during activities like walking.Expressed as a percentage (%) to indicate the level of symmetry.
Measured: 3 months
Secondary outcomes (2)
Bone remmant (%)
Bone remment respect a healthy femur in percentage (%)
Measured: 3 months
Long discrepancy (mm)
Long discrepancy in milimeters (mm) between healthy and tumoral leg. Positive discrepancy (tumoral leg longer) or negative discrepancy (tumoral leg shorter).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start8 Feb 2018
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Distal Femoral Musculoskeletal TumorsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
- Investigators
- JUAN FRANCISCO LISÓN, PhD, Study director, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202873
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-62
- Acronym
- MP-GP
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson PJ, Steadman P, Beckman EM, Connick MJ, Carty CP, Tweedy SM. Fitness, Function, and Exercise Training Responses after Limb Salvage With a Lower Limb Megaprosthesis: A Systematic Review. PM R. 2019 May;11(5):533-547. doi: 10.1002/pmrj.12045. Epub 2019 Mar 7.
PubMed 30844129Morri M, Forni C, Ruisi R, Giamboi T, Giacomella F, Donati DM, Benedetti MG. Postoperative function recovery in patients with endoprosthetic knee replacement for bone tumour: an observational study. BMC Musculoskelet Disord. 2018 Oct 2;19(1):353. doi: 10.1186/s12891-018-2280-7.
PubMed 30285683
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Spatiotemporal Gait Parameters in Patients With Distal Femoral Megaprosthesis and Healthy Subjects Using an Inertial Measurement Unit (IMU)
- ClinicalTrials.gov ID
- NCT05202873
- Acronym / sponsor ID
- MP-GP / UNIVERSITY CARDENAL HERRERA-62
- Keywords
- Gait Analysis, Case-control study, Megaprosthesis, Orthopedic oncology, Musculoskeletal tumour, Distal femur, Inertial Measurement Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 24 Jan 2022 (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.
The main objective of the study is to evaluate spatiotemporal parameters of gait in tumoral patients with megaprosthesis of the distal femur.
Detailed description
Patients with distal femoral prostheses treated at La Fe Hospital in Valencia were evaluated and compared with healthy controls. A radiographic study was conducted in cases using telemetric imaging to assess the percentage of remaining bone and the long length limb discrepancy following surgical intervention. Additionally, a gait analysis was performed using the BTS device to obtain objective gait parameters. The gait assessment was conducted with a non-invasive portable device, the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy), which was placed at the S1 level to collect spatio-temporal gait data. The data were analyzed in relation to the values in healthy patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Gait analysisPatients with distal femoral megaprosthesis due to musculoskeletal tumor |
| Control | – | Diagnostic Test: Gait analysisHealthy subjects |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent a megaprosthesis of the lower limb (distal femur) at Hospital La Fe by the orthopedic surgery and traumatology service, due to a tumor cause
Key inclusion criteria (5 listed)
- Megaprosthesis of the distal femur
- Tumor cause
- Surgery at Hospital la Fe.
- Traditional stem or biological ossteointegration system
- Minimum postoperative follow-up period of 3 months
Key exclusion criteria (5 listed)
- Neurological alterations prior to the intervention that affect the lower limbs or general movement.
- Patient incapable of ambulation due to progression of his/her pathology
- Patient at home with palliative treatment for advanced tumor disease
- Any ipsilateral or contralateral prosthesis.
- Infectious or traumatic cause
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 |
|---|---|---|
| Gait analysisGait assessment will be performed using a non-invasive device. It is the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy). The spatiotemporal variables of gait will be studied from the Walk+ protocol, in which the participant navigates a 7-meter hallway six times, completing three round trips with necessary turns at each end to change direction. | Diagnostic test | Cases, Control |
Primary outcome
Antero-posterior acceleration symmetry index
Time frame: 3 months
This metric serves as a quantifiable measure of the symmetry exhibited in movements along the antero-posterior axis, thereby illustrating the equilibrium and coordination inherent in the body's kinetic activities.
Stance Phase
Time frame: 3 months
Refers to the portion of the gait cycle during which a foot is in contact with the ground. It begins with the initial contact (heel strike) and ends when the same foot leaves the ground (toe-off). The stance phase is a critical component of walking and running, contributing to balance, propulsion, and weight-bearing. Measured as a percentage of the total gait cycle, 60% of the cycle in typical walking.
Swing Phase
Time frame: 3 months
Refers to the portion of the gait cycle during which a foot is not in contact with the ground. It begins when the foot lifts off the ground (toe-off) and ends when the same foot makes contact again (heel strike). The swing phase allows the leg to advance forward and position itself for the next step. Measured as a percentage of the total gait cycle, 40% of the cycle in normal walking.
Gait Quality Index
Time frame: 3 months
The stance-swing phase ratio
First Double support phase
Time frame: 3 months
Refers to the portion of the gait cycle during walking when both feet are in contact with the ground simultaneously. It occurs at the beginning of the stance phase for one leg, immediately after heel strike, and ends when the opposite foot lifts off (toe-off). This phase contributes to stability during gait. Measured as a percentage of the total gait cycle.
Single Support Phase
Time frame: 3 months
Refers to the portion of the gait cycle during which only one foot is in contact with the ground bearing the entire body weight while the other foot is in the swing phase. It is essential for maintaining balance and forward progression during walking. Measured as a percentage of the total gait cycle.
Propulsion Index
Time frame: 3 months
This measures the subject's ability to propel the centre of mass forward during the single support stance phase.
Pelvic tilt range
Time frame: 3 months
Refers to the total angular movement of the pelvis in the sagittal plane during a specific activity, such as walking. It represents the difference between the maximum anterior tilt (forward rotation) and maximum posterior tilt (backward rotation) of the pelvis within a given cycle. Measured in degrees (°) to quantify the extent of pelvic rotation.
Pelvic obliquity range
Time frame: 3 months
Refers to the total angular movement of the pelvis in the coronal (frontal) plane during activities such as walking. It describes the difference between the maximum upward tilt (hip hike) and maximum downward tilt (hip drop) of one side of the pelvis relative to the opposite side. Measured in degrees (°) to quantify the range of motion.
Pelvic rotation range
Time frame: 3 months
Refers to the total angular movement of the pelvis in the transverse (horizontal) plane during activities such as walking. It represents the difference between the maximum forward rotation and maximum backward rotation of the pelvis around a vertical axis within a given cycle. Measured in degrees (°) to quantify the range of rotational motion.
Pelvic symmetry tilt index
Time frame: 3 months
Is a quantitative measure that evaluates the symmetry of pelvic tilt during movement. It assesses the degree of deviation in pelvic tilt between the left and right sides in the sagittal plane, providing insight into potential imbalances or asymmetries. Expressed as a percentage (%) to indicate the level of symmetry.
Pelvic symmetry obliquity index
Time frame: 3 months
Is a quantitative measure used to evaluate the symmetry of pelvic obliquity during movement. It quantifies the degree of deviation in upward or downward tilt of the pelvis on one side compared to the other in the coronal (frontal) plane, helping to identify potential imbalances or asymmetries. Expressed as a percentage (%) to represent the level of symmetry.
Pelvic symmetry rotation index
Time frame: 3 months
Is a quantitative measure used to assess the symmetry of pelvic rotation during movement, particularly in the transverse (horizontal) plane. It calculates the difference in rotational movement between the left and right sides of the pelvis, helping to identify any imbalances or asymmetries in pelvic motion during activities like walking.Expressed as a percentage (%) to indicate the level of symmetry.
2 secondary outcomes
Bone remmant (%)
Time frame: 3 months
Long discrepancy (mm)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 30844129Wilson PJ, Steadman P, Beckman EM, Connick MJ, Carty CP, Tweedy SM. Fitness, Function, and Exercise Training Responses after Limb Salvage With a Lower Limb Megaprosthesis: A Systematic Review. PM R. 2019 May;11(5):533-547. doi: 10.1002/pmrj.12045. Epub 2019 Mar 7.
- Background: PubMed 30285683Morri M, Forni C, Ruisi R, Giamboi T, Giacomella F, Donati DM, Benedetti MG. Postoperative function recovery in patients with endoprosthetic knee replacement for bone tumour: an observational study. BMC Musculoskelet Disord. 2018 Oct 2;19(1):353. doi: 10.1186/s12891-018-2280-7.
- Individual participant dataSharing planned: No
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.
JUAN FRANCISCO LISÓN, PhD study director
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Femoral Musculoskeletal Tumors and Megaprosthesis, run by Cardenal Herrera University at 1 site in Spain.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 11 Dec 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antero-posterior acceleration symmetry index (time frame: 3 months). The study lists 13 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 NCT05202873, which also lists 2 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 11 Dec 2024.