Distal Femoral Musculoskeletal TumorsFOQ-DFPNCT06282198
Functional Outcomes and Quality of Life in Musculoskeletal Tumor Patients With Distal Femoral Megaprostheses
An observational study of Distal Femoral Musculoskeletal Tumors, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
This study aims to evaluate the functional outcomes of patients with distal femur tumor prostheses in comparison to a matched control group. 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
- How many people
- 79 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2018to 29 Oct 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: Cases: Patients with megaprosthesis of the distal femur due to tumor treated at Hospital Universitario la Fe. Controls: Healthy volunteers
Who may be able to join
- Megaprosthesis of unilateral distal femur
- Tumor cause
- Ambulation capacity
Who cannot join
- Neurological alterations prior to the inervention than affect the lower limbs or general movement
- Patient incapable of ambulation due to progression of his/her pathology
- Patient with palliative treatment for advanced tumor diseas
- More than one ipsilateral or contralateral prosthesis
- Infection, traumatic or sequel to revision surgery cause
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Functional Outcomes and Quality of Life in Musculoskeletal Tumor Patients With Distal Femoral Megaprostheses: A Case-Control Study
This study aims to evaluate the functional outcomes of patients with distal femur tumor prostheses in comparison to a matched control group.
Read the detailed description
The aim of this case-control study will be to compare functional outcomes-including results from the TUG and 6MWT, knee flexor and extensor muscle strength, sagittal knee range of motion-and health-related quality of life between patients with distal femoral megaprostheses and healthy controls. By employing both traditional assessments and IMU technology, the investigators will provide a comprehensive evaluation of functional recovery in this population, thereby informing clinical practice and rehabilitation strategies.
Two functional tests that will be conducted are the Time Up and Go Test and the 6-Minute Walk Test. These tests will be administered using a non-invasive Inertial Measurement Unit (IMU), specifically the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy), positioned at the S1 level to collect spatiotemporal gait data. These data will then be analyzed in comparison to values obtained from healthy participants.
The assessment will include anamnesis and a complete clinical examination of tumor patients with distal femur megaprostheses undergoing surgery at Hospital la Fe in Valencia, focusing on knee joint mobility and muscle group strength. Subjective function will be evaluated using questionnaires such as the SF-36 for both cases and controls and the MSTS (Musculoskeletal Tumor Society Score) for cases.
- Conditions
- Distal Femoral Musculoskeletal Tumors
- Keywords
- Megaprosthesis, Musculoskeletal tumor, Distal femur, Lower limb, Functional mobility, Quality of life, Case-Control Study, Inertial Measurement Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with Distal Femoral megaprosthesis | |
| Control | Healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 questionnaire
This instrument assesses health-related quality of life and comprises 36 items, organized into eight subscales: physical functioning (10 items), physical role functioning (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), emotional role functioning (3 items), and mental health (5 items). Each subscale is scored on a scale from 0 to 100, with higher scores indicating better health status in that domain.
In addition to individual subscale scores, two aggregate summary scores are calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). These summary scores are norm-based, with a mean of 50 and a standard deviation of 10, allowing comparison to population averages. Scores above 50 represent better-than-average health, while scores below 50 indicate lower-than-average health-related quality of life.
Measured: 3 months
Timed Up and Go Test
Participants are seated in a chair with their backs against the backrest and their hands resting on their thighs. Upon the verbal command "GO", they are instructed to stand, walk down a 3-meter pathway, turn around, and return to a seated position as quickly and safely as possible. The recorded parameters include total TUG time (s), rotation speed during the middle and final turns (°/s), and vertical acceleration during the sit-to-stand and stand-to-sit transitions (m/s²)
Measured: 3 months
6 -Minute Walk Test
This test is conducted in a continuous 30-meter corridor, where participants are instructed to walk for 6 minutes at their own preferred pace. The primary parameter measured is total walking distance (m)
Measured: 3 months
Secondary outcomes (3)
Sagittal range of movement of the knee measured with a goniometer
Sagittal range of movement of pathologic knee and healthy knee in controls.Full knee extension is considered 0º. The full range of knee mobility determined by the sum of the degrees of flexion plus the degrees of extension.
Measured: 3 months
Muscular strength
We measure muscle strength in the quadriceps and hamstrings of the pathological leg in the cases and one of the legs in the controls. For this we use the Medical Research Council Scale.
On this scale, contraction is assessed from 0-5.
Grade 5: Normal
Grade 4: Movement against gravity and resistance
Grade 3: Movement against gravity over (almost) the full range
Grade 2: Movement of the limb but not against gravity
Grade 1: Visible contraction without movement of the limb
Grade 0: No visible contraction
Measured: 3 months
MSTS Score
Musculoskeletal Tumour Society (MSTS) Score evaluates patients' subjective functional capabilities. This assessment comprises six subscales: pain, function, emotional acceptance, use of assistive devices for ambulation, walking ability, and gait. Each subscale is rated on a scale from 0 to 5 points, with 5 indicating the most favorable outcome. Total scores are categorized as follows: poor (<15%), fair (15-17%), moderate (18-20%), good (21-22%), and excellent (23-30%). Higher total scores reflect better functional performance
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 posted28 Feb 2024
- Study start1 Feb 2018
- Primary completion1 Sep 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 F Lisón, PhD, Study director, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282198
- Sponsor's protocol ID
- UCHCEU-13/02/24
- Acronym
- FOQ-DFP
- Status last verified
- Nov 2024
- First submitted
- 13 Feb 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Functional Outcomes and Quality of Life in Musculoskeletal Tumor Patients With Distal Femoral Megaprostheses: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06282198
- Acronym / sponsor ID
- FOQ-DFP / UCHCEU-13/02/24
- Conditions
- Distal Femoral Musculoskeletal Tumors
- Keywords
- Megaprosthesis, Musculoskeletal tumor, Distal femur, Lower limb, Functional mobility, Quality of life, Case-Control Study, Inertial Measurement Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 28 Feb 2024 (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.
This study aims to evaluate the functional outcomes of patients with distal femur tumor prostheses in comparison to a matched control group.
Detailed description
The aim of this case-control study will be to compare functional outcomes-including results from the TUG and 6MWT, knee flexor and extensor muscle strength, sagittal knee range of motion-and health-related quality of life between patients with distal femoral megaprostheses and healthy controls. By employing both traditional assessments and IMU technology, the investigators will provide a comprehensive evaluation of functional recovery in this population, thereby informing clinical practice and rehabilitation strategies.
Two functional tests that will be conducted are the Time Up and Go Test and the 6-Minute Walk Test. These tests will be administered using a non-invasive Inertial Measurement Unit (IMU), specifically the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy), positioned at the S1 level to collect spatiotemporal gait data. These data will then be analyzed in comparison to values obtained from healthy participants.
The assessment will include anamnesis and a complete clinical examination of tumor patients with distal femur megaprostheses undergoing surgery at Hospital la Fe in Valencia, focusing on knee joint mobility and muscle group strength. Subjective function will be evaluated using questionnaires such as the SF-36 for both cases and controls and the MSTS (Musculoskeletal Tumor Society Score) for cases.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients with Distal Femoral megaprosthesis |
| Control | – | –Healthy subjects |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases: Patients with megaprosthesis of the distal femur due to tumor treated at Hospital Universitario la Fe. Controls: Healthy volunteers
Key inclusion criteria (3 listed)
- Megaprosthesis of unilateral distal femur
- Tumor cause
- Ambulation capacity
Key exclusion criteria (5 listed)
- Neurological alterations prior to the inervention than affect the lower limbs or general movement
- Patient incapable of ambulation due to progression of his/her pathology
- Patient with palliative treatment for advanced tumor diseas
- More than one ipsilateral or contralateral prosthesis
- Infection, traumatic or sequel to revision surgery cause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SF-36 questionnaire
Time frame: 3 months
This instrument assesses health-related quality of life and comprises 36 items, organized into eight subscales: physical functioning (10 items), physical role functioning (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), emotional role functioning (3 items), and mental health (5 items). Each subscale is scored on a scale from 0 to 100, with higher scores indicating better health status in that domain. In addition to individual subscale scores, two aggregate summary scores are calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). These summary scores are norm-based, with a mean of 50 and a standard deviation of 10, allowing comparison to population averages. Scores above 50 represent better-than-average health, while scores below 50 indicate lower-than-average health-related quality of life.
Timed Up and Go Test
Time frame: 3 months
Participants are seated in a chair with their backs against the backrest and their hands resting on their thighs. Upon the verbal command "GO", they are instructed to stand, walk down a 3-meter pathway, turn around, and return to a seated position as quickly and safely as possible. The recorded parameters include total TUG time (s), rotation speed during the middle and final turns (°/s), and vertical acceleration during the sit-to-stand and stand-to-sit transitions (m/s²)
6 -Minute Walk Test
Time frame: 3 months
This test is conducted in a continuous 30-meter corridor, where participants are instructed to walk for 6 minutes at their own preferred pace. The primary parameter measured is total walking distance (m)
3 secondary outcomes
Sagittal range of movement of the knee measured with a goniometer
Time frame: 3 months
Muscular strength
Time frame: 3 months
MSTS Score
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 5 Nov 2024.
- Individual participant dataSharing planned: Undecided
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 F 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, 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 3 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 5 Nov 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?
SF-36 questionnaire (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2024.