AtrophyNCT02781623
Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture
An observational study of Atrophy, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will quantify and examine the extent to which the quadriceps femoris muscle group atrophies following tibial plateau fractures and the length of time that atrophy affects function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atrophy
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 18 Jan 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who opt for surgical treatment or non-operative treatment of their fracture.
Who may be able to join
- All racial and ethnic groups
- Diagnosis of tibial plateau fracture
- Patients who opt for surgical treatment or non-operative treatment of their fracture
- Patients who consent to undergoing 3 MRI scans
- Patients who are willing to follow-up for a minimum of 52 weeks
Who cannot join
- Patients younger than 18 years old or older than 65
- Patients who may be pregnant or may become pregnant in the 52 weeks following injury
- Patients who have electric, magnetic, or mechanical devices currently implanted
- Patients who have abnormal ECG results
- Diagnosis of any additional lower extremity fractures other than tibial plateau
- Patients who fit the definition of a vulnerable population
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Medical Center
New York, New York, 10016
About this study
This study will quantify and examine the extent to which the quadriceps femoris muscle group atrophies following tibial plateau fractures and the length of time that atrophy affects function. The study will also look at the effects of tibial plateau fractures on the quadriceps muscle and the effect this atrophy has on functional outcome. Quadriceps atrophy will be measured both clinically and by using MRI scans taken pre-operatively, 3 months post operatively, and 1 year post-operatively. The injured leg and the non-injured leg will be scanned in order for the non-injured leg to serve as the control. In this way muscle volume can be estimated from the muscle thickness at specific locations in the thigh. The muscle strength of the quadriceps will also be assessed at the 3 month and 1 year visit by measuring isokinetic knee-extension torque, and functional assessment questionnaires will be completed at each study visit.
- Conditions
- Atrophy
- Being tested
- MRI
- Keywords
- Quadriceps, Tibial Plateau, Fracture
- Medical subject headings
- Atrophy, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MRI | An MRI will be conducted pre-operatively, 3 months post-operatively, and 1 year post-operatively. Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area (CSA) calculations
From the axial images obtained from the MRI for each leg, outlines of each muscle in the quadriceps femoris muscle group will be traced and used to calculate.
Measured: 1 Year
Quadriceps muscle strength
This will be measured by the highest knee-extension torque over six repetitions for each leg.
Measured: One Year
Muscle Volume
This will be measured by the sum of the CSAs (Cross Sectional Areas) of each image times the thickness (10mm) and interslice gap (10mm) of each section
Measured: One Year
Pain Level
This will be measured by the Short Musculoskeletal Function Assessment Questionnaire (SMFA)
Measured: One Year
Secondary outcomes (1)
Isokinetic Knee-Extension Strength Test
This test will be conducted on both legs to compare the physical strength of the injured leg with the non-injured leg.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startOct 2015
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtrophyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneeth Egol, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781623
- Sponsor's protocol ID
- 15-00985
- Status last verified
- Nov 2022
- First submitted
- 20 May 2016
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture
- ClinicalTrials.gov ID
- NCT02781623
- Acronym / sponsor ID
- 15-00985
- Conditions
- Atrophy
- Keywords
- Quadriceps, Tibial Plateau, Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 24 May 2016 (estimated)
- 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 will quantify and examine the extent to which the quadriceps femoris muscle group atrophies following tibial plateau fractures and the length of time that atrophy affects function. The study will also look at the effects of tibial plateau fractures on the quadriceps muscle and the effect this atrophy has on functional outcome. Quadriceps atrophy will be measured both clinically and by using MRI scans taken pre-operatively, 3 months post operatively, and 1 year post-operatively. The injured leg and the non-injured leg will be scanned in order for the non-injured leg to serve as the control. In this way muscle volume can be estimated from the muscle thickness at specific locations in the thigh. The muscle strength of the quadriceps will also be assessed at the 3 month and 1 year visit by measuring isokinetic knee-extension torque, and functional assessment questionnaires will be completed at each study visit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | – | Procedure: MRIAn MRI will be conducted pre-operatively, 3 months post-operatively, and 1 year post-operatively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who opt for surgical treatment or non-operative treatment of their fracture.
Key inclusion criteria (5 listed)
- All racial and ethnic groups
- Diagnosis of tibial plateau fracture
- Patients who opt for surgical treatment or non-operative treatment of their fracture
- Patients who consent to undergoing 3 MRI scans
- Patients who are willing to follow-up for a minimum of 52 weeks
Key exclusion criteria (6 listed)
- Patients younger than 18 years old or older than 65
- Patients who may be pregnant or may become pregnant in the 52 weeks following injury
- Patients who have electric, magnetic, or mechanical devices currently implanted
- Patients who have abnormal ECG results
- Diagnosis of any additional lower extremity fractures other than tibial plateau
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 |
|---|---|---|
| MRI | Procedure or surgery | MRI |
Primary outcome
Cross-sectional area (CSA) calculations
Time frame: 1 Year
From the axial images obtained from the MRI for each leg, outlines of each muscle in the quadriceps femoris muscle group will be traced and used to calculate.
Quadriceps muscle strength
Time frame: One Year
This will be measured by the highest knee-extension torque over six repetitions for each leg.
Muscle Volume
Time frame: One Year
This will be measured by the sum of the CSAs (Cross Sectional Areas) of each image times the thickness (10mm) and interslice gap (10mm) of each section
Pain Level
Time frame: One Year
This will be measured by the Short Musculoskeletal Function Assessment Questionnaire (SMFA)
1 secondary outcome
Isokinetic Knee-Extension Strength Test
Time frame: One year
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 16 Nov 2022.
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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.
Kenneeth Egol, MD principal investigator
NYU Langone Health
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 Atrophy, run by NYU Langone Health at 1 site in United States.
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 6 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 16 Nov 2022. 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 States. 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?
Cross-sectional area (CSA) calculations (time frame: 1 Year). The study lists 4 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 16 Nov 2022.