SarcomaNCT04911972
Functional Muscle Transfers in Lower Limb Sarcoma: 3D Gait Analysis and Environmental Simulation
An observational study of Sarcoma and Muscle Tumor, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess patient's function after functional limb restoring surgery, performed after ablative tumour surgery or trauma. However, there are no studies as yet providing objective proof of the recovery of function after this type of surgery. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Sarcoma, Muscle Tumor, Muscle Loss
- What is being tested?
- Functional muscle transfer
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2016to 1 Jul 2021
- 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 18 to 95 years
- All sexes
- Adult, Older adult
Study population: Population study groups will be taken from the Scottish Sarcoma Network Glasgow centre's patient cohort
Who may be able to join
- Patients who have undergone major surgery for tumour, resulting in significant muscle loss in the West of Scotland
- At least 3 months post-surgery
Who cannot join
- Patients with ongoing surgical complications
- < 3 months post-surgery
- Patients currently undergoing radiotherapy
- Patients with known motion sickness (related to Virtual Reality component of gait analysis)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Canniesburn Regional Plastic Surgery and Burns Unit
Glasgow, Scotland, G4 0SF
About this study
Official title: Functional Muscle Transfers to Restore Normal Function After Major Lower Limb Sarcoma/ Trauma - Assessment by Gait Analysis and Virtual Reality Environmental Simulation
The purpose of this study is to assess patient's function after functional limb restoring surgery, performed after ablative tumour surgery or trauma. However, there are no studies as yet providing objective proof of the recovery of function after this type of surgery. This study will use 3D Gait Analysis, Environmental simulation and Patient Reported Outcome Measures to compare patients with function restoring surgery against patients without function restoring surgery.
Read the detailed description
Introduction
Rationale
The purpose of this study is to assess patient's function after functional limb restoring surgery, performed after ablative tumour surgery or trauma. However, there are no studies as yet providing objective proof of the recovery of function after this type of surgery.
Background information including literature review
Sarcoma surgery has progressed from limb amputation to limb preserving surgery since the early 1980s. Although this has been a major advance, a preserved limb does not equate to a functional limb. Patients may be left with significant disability and reliant on walking aids or braces, and unable to return to normal activities
The West of Scotland Sarcoma service has developed and refined surgical procedures to restore function in the lower limb after major resection surgery. This is one of the few centres in the world that have done significant numbers of function restoring surgeries, and are recognised as experts in this field, having published the protocol for functional reconstruction in the Journal of Bone and Joint Surgery and in the book Reconstructive Surgery of the Lower Extremity.
Procedures for functional restoration include Quadriceps reconstruction (to restore knee extension) - this is the most common type of functional lower limb reconstruction. Hamstring transfers were originally described for use in polio over a century ago, sartorius transfers, and free functional muscles transfers such as the latissimus dorsi or contralateral rectus femoris/ vastus lateralis.
Other techniques for functional reconstruction include anterior leg compartment reconstruction (to restore foot dorsiflexion/ prevent foot-drop) and posterior leg compartment reconstruction (to restore plantar-flexion). Techniques such as the free functional anterolateral thigh - rectus femoris muscle combined flap are also used.
Previous studies have not provided objective proof of restoration of gait, and have been limited to scores such as the Musculoskeletal Tumor Society Score (MSTS), range of motion, and Medical Research Council (MRC) grade power. These scores are of limited value in establishing whether a patient's gait is normal, and may be subject to investigator bias.
Two objective techniques will be used to assess normality of gait after functional reconstruction:
- Three-dimensional clinical gait analysis (3DCGA) provides a robust and objective technique for measurement of how an individual walks both for clinical use and for research purposes.
- Environmental Simulator (the Motek system at Strathclyde University): this is the only environmental simulator of its type out-with the Ministry of Defence in the United Kingdom. It provides simulated environments on a large projected screen with the patient attached to a safety harness, whilst walking on an adjustable treadmill. This allows simulation of urban environments, negotiation of trip hazards, walking up hills and shopping tasks. This will permit more tangible answers regarding the objective return to function of patients in an environmental context that they can understand eg "Will I be able to go hillwalking?" "Will I be safe to go shopping without crutches or a brace?".
Aim/Primary and Secondary Objectives
The aim of this study is to objectively assess the normality of gait after functional reconstructive surgery, and to assess whether patients can return to activities of daily living using the Environmental simulator
Methodology
Patients who have undergone functional reconstructive surgery will be identified from a prospectively held database. The patients will be invited to participate by letter and given an information sheet. Should the patient wish to participate in the study they will be invited to clinic to discuss the study with the senior researcher (SL) and sign a consent form related to gait analysis and the environmental simulator.
There are 3 components to the study:
- Patient Reported Outcome Measurements - using validated questionnaires including the Toronto Extremity Salvage Score (TESS). Clinical assessment will include MRC grade power and range of motion.
- 3D Gait analysis - this employs 3D cameras and pressure sensors to objectively assess the patient's ability to walk, and can identify subtle differences in gait that cannot be identified on questionnaires or on simple video analysis. Electromyography may be used to assess active muscle contraction as part of the gait analysis.
- Environmental simulator - this will employ a state-of-the-art simulator that can assess a patient's ability to navigate simulated environments eg walking up a hill, navigating an urban environment, and shopping tasks.
- Conditions
- Sarcoma, Muscle Tumor, Muscle Loss
- Being tested
- Functional muscle transfer
- Medical subject headings
- Sarcoma, Muscle Neoplasms, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional muscle transferProcedure or surgery
Muscle transfer to restore lower limb function
| Study group | Role | What they receive |
|---|---|---|
| Functional muscle transfer group | Patients who have undergone functional muscle transfer to restore function after tumour surgery or injury, in which the tumour surgery or injury has resulted in functional loss. Receives: Procedure: Functional muscle transfer | |
| Non-functional muscle transfer group | Patients who have not undergone functional muscle transfer to restore function after tumour surgery or injury, in which the tumour surgery or injury has resulted in functional loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Profile Score (GPS)
Objective score from 3D Gait Analysis. This is a continuous score with no minimum or maximum score, where lower scores indicate better gait.
Measured: Up to 10 years after surgery. From date of surgery, but after completion of post-operative rehabilitation at 6 months up to 10 years following surgery
Secondary outcomes (2)
Environmental Simulator assessment of ability to complete Tasks of Daily Living
Descriptive outcome measure on ability to complete simulator tasks which replicate activities of daily living.
Measured: Up to 10 years after surgery. From date of surgery, but after completion of post-operative rehabilitation at 6 months up to 10 years following surgery
Toronto Extremity Salvage Score (TESS)
Patient reported outcome measure on function after surgery. This is a continuous score which is converted to a 0 to 100 score. Higher indicates better functional outcomes.
Measured: Up to 10 years after surgery. From date of surgery, but after completion of post-operative rehabilitation at 6 months up to 10 years following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jan 2016
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Strathclyde
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911972
- Sponsor's protocol ID
- GN17OR618
- Status last verified
- Dec 2021
- First submitted
- 15 May 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared on reasonable written request
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Muscle Transfers to Restore Normal Function After Major Lower Limb Sarcoma/ Trauma - Assessment by Gait Analysis and Virtual Reality Environmental Simulation
- ClinicalTrials.gov ID
- NCT04911972
- Acronym / sponsor ID
- GN17OR618
- Conditions
- Sarcoma, Muscle Tumor, Muscle Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Strathclyde
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 3 Jun 2021 (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 purpose of this study is to assess patient's function after functional limb restoring surgery, performed after ablative tumour surgery or trauma. However, there are no studies as yet providing objective proof of the recovery of function after this type of surgery. This study will use 3D Gait Analysis, Environmental simulation and Patient Reported Outcome Measures to compare patients with function restoring surgery against patients without function restoring surgery.
Detailed description
Introduction
Rationale
The purpose of this study is to assess patient's function after functional limb restoring surgery, performed after ablative tumour surgery or trauma. However, there are no studies as yet providing objective proof of the recovery of function after this type of surgery.
Background information including literature review
Sarcoma surgery has progressed from limb amputation to limb preserving surgery since the early 1980s. Although this has been a major advance, a preserved limb does not equate to a functional limb. Patients may be left with significant disability and reliant on walking aids or braces, and unable to return to normal activities
The West of Scotland Sarcoma service has developed and refined surgical procedures to restore function in the lower limb after major resection surgery. This is one of the few centres in the world that have done significant numbers of function restoring surgeries, and are recognised as experts in this field, having published the protocol for functional reconstruction in the Journal of Bone and Joint Surgery and in the book Reconstructive Surgery of the Lower Extremity.
Procedures for functional restoration include Quadriceps reconstruction (to restore knee extension) - this is the most common type of functional lower limb reconstruction. Hamstring transfers were originally described for use in polio over a century ago, sartorius transfers, and free functional muscles transfers such as the latissimus dorsi or contralateral rectus femoris/ vastus lateralis.
Other techniques for functional reconstruction include anterior leg compartment reconstruction (to restore foot dorsiflexion/ prevent foot-drop) and posterior leg compartment reconstruction (to restore plantar-flexion). Techniques such as the free functional anterolateral thigh - rectus femoris muscle combined flap are also used.
Previous studies have not provided objective proof of restoration of gait, and have been limited to scores such as the Musculoskeletal Tumor Society Score (MSTS), range of motion, and Medical Research Council (MRC) grade power. These scores are of limited value in establishing whether a patient's gait is normal, and may be subject to investigator bias.
Two objective techniques will be used to assess normality of gait after functional reconstruction:
- Three-dimensional clinical gait analysis (3DCGA) provides a robust and objective technique for measurement of how an individual walks both for clinical use and for research purposes.
- Environmental Simulator (the Motek system at Strathclyde University): this is the only environmental simulator of its type out-with the Ministry of Defence in the United Kingdom. It provides simulated environments on a large projected screen with the patient attached to a safety harness, whilst walking on an adjustable treadmill. This allows simulation of urban environments, negotiation of trip hazards, walking up hills and shopping tasks. This will permit more tangible answers regarding the objective return to function of patients in an environmental context that they can understand eg "Will I be able to go hillwalking?" "Will I be safe to go shopping without crutches or a brace?".
Aim/Primary and Secondary Objectives
The aim of this study is to objectively assess the normality of gait after functional reconstructive surgery, and to assess whether patients can return to activities of daily living using the Environmental simulator
Methodology
Patients who have undergone functional reconstructive surgery will be identified from a prospectively held database. The patients will be invited to participate by letter and given an information sheet. Should the patient wish to participate in the study they will be invited to clinic to discuss the study with the senior researcher (SL) and sign a consent form related to gait analysis and the environmental simulator.
There are 3 components to the study:
- Patient Reported Outcome Measurements - using validated questionnaires including the Toronto Extremity Salvage Score (TESS). Clinical assessment will include MRC grade power and range of motion.
- 3D Gait analysis - this employs 3D cameras and pressure sensors to objectively assess the patient's ability to walk, and can identify subtle differences in gait that cannot be identified on questionnaires or on simple video analysis. Electromyography may be used to assess active muscle contraction as part of the gait analysis.
- Environmental simulator - this will employ a state-of-the-art simulator that can assess a patient's ability to navigate simulated environments eg walking up a hill, navigating an urban environment, and shopping tasks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional muscle transfer group | – | Procedure: Functional muscle transferPatients who have undergone functional muscle transfer to restore function after tumour surgery or injury, in which the tumour surgery or injury has resulted in functional loss. |
| Non-functional muscle transfer group | – | –Patients who have not undergone functional muscle transfer to restore function after tumour surgery or injury, in which the tumour surgery or injury has resulted in functional loss. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Population study groups will be taken from the Scottish Sarcoma Network Glasgow centre's patient cohort
Key inclusion criteria (2 listed)
- Patients who have undergone major surgery for tumour, resulting in significant muscle loss in the West of Scotland
- At least 3 months post-surgery
Key exclusion criteria (4 listed)
- Patients with ongoing surgical complications
- < 3 months post-surgery
- Patients currently undergoing radiotherapy
- Patients with known motion sickness (related to Virtual Reality component of gait analysis)
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 |
|---|---|---|
| Functional muscle transferMuscle transfer to restore lower limb function | Procedure or surgery | Functional muscle transfer group |
Primary outcome
Gait Profile Score (GPS)
Time frame: Up to 10 years after surgery. From date of surgery, but after completion of post-operative rehabilitation at 6 months up to 10 years following surgery
Objective score from 3D Gait Analysis. This is a continuous score with no minimum or maximum score, where lower scores indicate better gait.
2 secondary outcomes
Environmental Simulator assessment of ability to complete Tasks of Daily Living
Time frame: Up to 10 years after surgery. From date of surgery, but after completion of post-operative rehabilitation at 6 months up to 10 years following surgery
Toronto Extremity Salvage Score (TESS)
Time frame: Up to 10 years after surgery. From date of surgery, but after completion of post-operative rehabilitation at 6 months up to 10 years following surgery
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 13 Dec 2021.
- Individual participant dataSharing planned: Undecided. Data will be shared on reasonable written request
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sarcoma and Muscle Tumor, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 13 Dec 2021. 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 United Kingdom. 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?
Gait Profile Score (GPS) (time frame: Up to 10 years after surgery. From date of surgery, but after completion of post-operative rehabilitation at 6 months up to 10 years following surgery). 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 13 Dec 2021.