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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United Kingdom

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:

  1. 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.
  2. 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:

  1. 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.
  2. 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.
  3. 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.
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 groups in NCT04911972
Study groupRoleWhat they receive
Functional muscle transfer groupPatients 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 groupPatients 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted3 Jun 2021
  2. Study start1 Jan 2016
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

Resources

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)
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

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.

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Clinical Trial NCT04911972 | AzTrials