Meniscus InjuryMENI-FOOTNCT03379415
The Effect of Commercially Available Footwear Interventions in Meniscectomy Patients
A study testing Footwear and Gait analysis in people with Meniscus Injury and Osteoarthritis, Knee, run by University of Salford at 1 site in United Kingdom.
Trial summary
Injuries to the meniscus are common in sport. A meniscectomy is often performed to manage symptoms associated with the meniscal injury. Following a meniscectomy individuals are highly likely to develop knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Meniscus Injury, Osteoarthritis, Knee, Footwear
- What is being tested?
- Footwear and Gait analysis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2018to 20 Sep 2020
- Phase
- Interventional
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 40 years
- Compete and or play sport a minimum two times a week
- Able to perform sport specific tasks including running, single leg landing and small knee bend squat
- Meniscectomy group - has had a meniscectomy surgery following a traumatic meniscal injury during a sporting task.
Who cannot join
- History of lower extremity surgeries (other than a meniscectomy) e.g. ACL reconstruction
- Evidence of knee osteoarthritis development either assessed clinically (based on ACR criteria) or radiographically (Kellgren-Lawrence grade >1)
- Previous history of traumatic (other than the sustained meniscal injury), inflammatory or infectious pathology in the lower extremity
- Evidence of ligament laxity
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester Institute of Health and Performance
Manchester, Lancashire, M11 2AZ
About this study
Official title: The Effect of Commercially Available Footwear Interventions on Biomechanical Outcomes Associated With Knee Osteoarthritis in Meniscectomy Patients
Injuries to the meniscus are common in sport. A meniscectomy is often performed to manage symptoms associated with the meniscal injury. Following a meniscectomy individuals are highly likely to develop knee osteoarthritis (OA). Footwear interventions have demonstrated biomechanical changes during walking and running, in healthy and individuals with osteoarthritis. With the increased risk of developing OA associated with meniscectomy patients, understanding biomechanical changes with footwear when compared to healthy individuals, may provide a conservative approach to delaying or minimising the development of (OA). There is no current literature assessing the effect footwear has post meniscectomy, so this is a very novel approach and can yield important results for the management of future risks. Current evidence supports the use of footwear interventions aiming to minimise OA progression in older adults during walking. Yet, meniscectomy patients who have sustained an injury during sport are likely to continue to participate in sport following treatment in their usual footwear. Further evidence is required to better understand the effect of footwear interventions during dynamic movements often performed in sport. Previous studies have assessed customised footwear interventions, however these interventions are not representative of commercially available interventions that could be widely used by the general population. Therefore assessing commercially available footwear will give a more realistic approach to conservative treatment for meniscectomy patients. This project aims to examine biomechanical differences between commercially available footwear conditions in healthy individuals and individuals who have had a meniscal injury. Three-dimensional kinetic and kinematic measures will be assessed during five tasks (walking, running, 90 degrees side cut, single leg landing, and small knee bend squat), for different footwear conditions.
Read the detailed description
Injuries to the meniscus are common in sport, often as a result of a traumatic event. Mitchell et al. (2016) reported 5.1 meniscal injuries per 100 000 athletic exposures, with a greater proportion reported during competition (11.9 injuries per 100 000 athletic exposures), compared to practice (2.7 injuries per 100 000 athletic exposures). Rotation around a planted/ inverted foot has been cited as a common mechanism for meniscal injuries, followed by landing and jumping movements. The meniscus aids in stabilising the knee, acting as a shock absorber and transmitting load. Damage to the meniscus is suggest to lead to altered knee mechanics leading to the initiation or acceleration of osteoarthritis (OA) development. Prior meniscal tears are commonly reported in OA patients, in addition, reports suggest 4 to 14 times increased risk of developing OA following a meniscal injury.
Altered knee mechanics have been reported following a meniscal injury, which have been associated with increased likelihood of developing OA. These changes include reduced contact area within the joint and increased contact pressure, resulting in reduced ability to transmit load. Indirect measures of knee loading, such as external knee adductor moments (EKAM) and knee adduction angular impulses (KAAI), have been associated with increased risk of developing OA. Knee joint loading is also determined by the coordination of muscle activity. Greater and longer co-contractions of the medial muscles at the knee have demonstrated faster development of OA in individuals diagnosed with medial knee OA.
Meniscectomies are widely used to manage the symptoms associated with meniscus injuries. Whilst, non-operative therapies have demonstrated improvements in knee pain three years post intervention. However, following these interventions, alter mechanics of the knee have been observed. For instance, following a medial meniscectomy, increases in contact area and pressure at the knee have been observed and suggested to increase the likelihood of developing OA. Increases in EKAM in meniscectomy patients have been associated with changes in tibia alignment and GRF lever arm. Non-invasive interventions such as footwear, could alter biomechanics to lower EKAM and reduce the progression of OA. Following a meniscectomy procedure, most patients tend to go back to wearing their old trainers. Due to the changes in the biomechanics of the knee, it can be assumed that they support and cushioning they need would change too.
Typical sports movements such as landing and cutting require dynamic control of the knee which is very under-researched. Muscle strength recovery is also considered to be important for young individuals after an arthroscopic surgery in order to regain capacity to participate in sports or other activities as both pre- and post-operative knee extensor strength have been reported to predict better functional outcome of knee surgery. The co-contraction between the quadriceps and hamstrings are also important in this as muscle weakness creates a less stable base. Muscle strength is also essential to control movements such as stair descent which is essential for everyday living. This is closely linked with balance and the risk of falling. Having extra support or cushioning in footwear can help aid this control needed for static and dynamic exercises especially post-surgical intervention.
Different footwear interventions have been used in OA patients to reduce knee loading and pain. Lateral wedges have demonstrated reduced medial knee loading in both affected and contralateral limbs. In addition, mobility shoes and lateral wedges which provide additional medial support have been shown to reduce pain in OA patients. However, it is unclear whether footwear interventions are able to alleviate the risk factors associated with the progression of OA following a meniscal injury. For effective self-management, post operation the appropriate footwear is recommended, however there is little evidence to inform what the appropriate footwear is for patient after surgery or with knee OA.
Current evidence on footwear interventions on minimising OA development relies on assessment of linear movements such as walking and running. Yet, it is likely that athletes who sustain a meniscal injury would return to sport and therefore be required to perform movements that require a greater demand and muscular control then reported during walking. It is unclear whether footwear interventions are able to alleviate the risk factors associated with the progression of OA following a meniscal injury in a younger athletic population. Understanding knee loading during sport-specific movements and between sports footwear can provide a greater insight to the risk of OA development for athletic populations. Therefore understanding the effect of commercially available footwear interventions knee loading during sport-specific movements could provide a greater insight to the use conservative interventions to reducing the risk of OA development for athletic populations.
- Conditions
- Meniscus Injury, Osteoarthritis, Knee, Footwear
- Being tested
- Footwear, Gait analysis
- Keywords
- Meniscectomy, Footwear, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FootwearDevice
Different types of footwear will be tested to see if these can be used to help slow the progression of osteoarthritis in meniscectomy patients or even stop it from occurring.
Gait analysisProcedure or surgery
Gait analysis will be done during several different tasks wear the footwear
| Study group | Role | What they receive |
|---|---|---|
| Meniscus Injured | Experimental | These meniscus patients will be recruited to participate in a single session to wear 4 different pairs of shoes Receives: Device: Footwear |
| Footwear | Experimental | 4 Different types of trainers will be used to see the difference in gait in meniscectomy patients Receives: Procedure: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanical analysis using 3D motion capture looking at kinematics and kinetics
Knee adduction moment curve (different peaks) will be assessed for differences between conditions.
Measured: Change from Baseline until 1 year
Electromyography analysis of muscle co-contraction
The co-activation of quadriceps and hamstrings will be analysed using EMG. EMG will first be normalized using MVC and then the co-contraction will be analysed.
Measured: Change from Baseline until 1 year
Biomechanical analysis using 3D motion capture looking at kinematics and kinetics
Knee adduction angular impulse (the area under the curve) will be assessed for differences between conditions.
Measured: Change from Baseline until 1 year
Secondary outcomes (4)
Knee injury and osteoarthritis outcome score (KOOS)
The KOOS consists of five subscales; Pain, other symptoms, function in daily living (ADL), function in sport and recreation (Sport/Rec) and knee related quality of life (QOL). A five point Likert scale is employed in the questionnaire, with the last week is taken into consideration when answering the questions. A normalised score is calculated for each sub-scale with a score of 100 indicting no symptoms, whilst 0 indicates extreme symptoms.
Measured: Change from Baseline until 1 year
Patient-perceived global change in pain
Patients-perceived global change in pain will be assessed during the tasks. Participants will be asked to complete the five point Likert scale (1 - much worse, 2 - slightly worse, 3 - no change, 4 - slightly better, 5 - much better) following each task (Hinman et al., 2008).
Measured: Change from Baseline until 1 year
Tampa Scale of Kinesiophobia (TSK)
The TSK is a 17-item questionnaire, which asks individuals to rate the extent to which they agree with statements such as 'pain always means that I injured my body' on a 4-point rating scale, with 1 = strongly disagree and 4 = strongly agree (Nicholas et al., 2008). This is to look at whether any changes in the data are because a participant physically cannot move any different or whether they are subconsciously cautious because they have a fear of pain (Miller, Kori and Todd 1991).
Measured: Change from Baseline until 1 year
Comfort Rating Questionnaire
Differences in the overall comfort of the footwear will be assessed using a 10 cm visual analogue scale (Appendix 9). This measure has been reported to be reliable assessment of comfort (Mündermann et al., 2002). Comfort ratings have been show to detect likelihood of compliance and has been related to injury prevalence (Mündermann et al., 2001).
Measured: Change from Baseline until 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Feb 2018
- Primary completion20 Sep 2019
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meniscus InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Testing meniscus patients for several different shoes
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Walters, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379415
- Sponsor's protocol ID
- HSR1617-140
- Acronym
- MENI-FOOT
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research data will only be shared in the research team participating in this study.
Publications
Starbuck C, Walters V, Herrington L, Barkatali B, Jones R. Knee Offloading by Patients During Walking and Running After Meniscectomy. Orthop J Sports Med. 2024 Mar 21;12(3):23259671231214766. doi: 10.1177/23259671231214766. eCollection 2024 Mar.
PubMed 38524891
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Commercially Available Footwear Interventions on Biomechanical Outcomes Associated With Knee Osteoarthritis in Meniscectomy Patients
- ClinicalTrials.gov ID
- NCT03379415
- Acronym / sponsor ID
- MENI-FOOT / HSR1617-140
- Conditions
- Meniscus Injury, Osteoarthritis, Knee, Footwear
- Keywords
- Meniscectomy, Footwear, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 20 Dec 2017 (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.
Injuries to the meniscus are common in sport. A meniscectomy is often performed to manage symptoms associated with the meniscal injury. Following a meniscectomy individuals are highly likely to develop knee osteoarthritis (OA). Footwear interventions have demonstrated biomechanical changes during walking and running, in healthy and individuals with osteoarthritis. With the increased risk of developing OA associated with meniscectomy patients, understanding biomechanical changes with footwear when compared to healthy individuals, may provide a conservative approach to delaying or minimising the development of (OA). There is no current literature assessing the effect footwear has post meniscectomy, so this is a very novel approach and can yield important results for the management of future risks. Current evidence supports the use of footwear interventions aiming to minimise OA progression in older adults during walking. Yet, meniscectomy patients who have sustained an injury during sport are likely to continue to participate in sport following treatment in their usual footwear. Further evidence is required to better understand the effect of footwear interventions during dynamic movements often performed in sport. Previous studies have assessed customised footwear interventions, however these interventions are not representative of commercially available interventions that could be widely used by the general population. Therefore assessing commercially available footwear will give a more realistic approach to conservative treatment for meniscectomy patients. This project aims to examine biomechanical differences between commercially available footwear conditions in healthy individuals and individuals who have had a meniscal injury. Three-dimensional kinetic and kinematic measures will be assessed during five tasks (walking, running, 90 degrees side cut, single leg landing, and small knee bend squat), for different footwear conditions.
Detailed description
Injuries to the meniscus are common in sport, often as a result of a traumatic event. Mitchell et al. (2016) reported 5.1 meniscal injuries per 100 000 athletic exposures, with a greater proportion reported during competition (11.9 injuries per 100 000 athletic exposures), compared to practice (2.7 injuries per 100 000 athletic exposures). Rotation around a planted/ inverted foot has been cited as a common mechanism for meniscal injuries, followed by landing and jumping movements. The meniscus aids in stabilising the knee, acting as a shock absorber and transmitting load. Damage to the meniscus is suggest to lead to altered knee mechanics leading to the initiation or acceleration of osteoarthritis (OA) development. Prior meniscal tears are commonly reported in OA patients, in addition, reports suggest 4 to 14 times increased risk of developing OA following a meniscal injury.
Altered knee mechanics have been reported following a meniscal injury, which have been associated with increased likelihood of developing OA. These changes include reduced contact area within the joint and increased contact pressure, resulting in reduced ability to transmit load. Indirect measures of knee loading, such as external knee adductor moments (EKAM) and knee adduction angular impulses (KAAI), have been associated with increased risk of developing OA. Knee joint loading is also determined by the coordination of muscle activity. Greater and longer co-contractions of the medial muscles at the knee have demonstrated faster development of OA in individuals diagnosed with medial knee OA.
Meniscectomies are widely used to manage the symptoms associated with meniscus injuries. Whilst, non-operative therapies have demonstrated improvements in knee pain three years post intervention. However, following these interventions, alter mechanics of the knee have been observed. For instance, following a medial meniscectomy, increases in contact area and pressure at the knee have been observed and suggested to increase the likelihood of developing OA. Increases in EKAM in meniscectomy patients have been associated with changes in tibia alignment and GRF lever arm. Non-invasive interventions such as footwear, could alter biomechanics to lower EKAM and reduce the progression of OA. Following a meniscectomy procedure, most patients tend to go back to wearing their old trainers. Due to the changes in the biomechanics of the knee, it can be assumed that they support and cushioning they need would change too.
Typical sports movements such as landing and cutting require dynamic control of the knee which is very under-researched. Muscle strength recovery is also considered to be important for young individuals after an arthroscopic surgery in order to regain capacity to participate in sports or other activities as both pre- and post-operative knee extensor strength have been reported to predict better functional outcome of knee surgery. The co-contraction between the quadriceps and hamstrings are also important in this as muscle weakness creates a less stable base. Muscle strength is also essential to control movements such as stair descent which is essential for everyday living. This is closely linked with balance and the risk of falling. Having extra support or cushioning in footwear can help aid this control needed for static and dynamic exercises especially post-surgical intervention.
Different footwear interventions have been used in OA patients to reduce knee loading and pain. Lateral wedges have demonstrated reduced medial knee loading in both affected and contralateral limbs. In addition, mobility shoes and lateral wedges which provide additional medial support have been shown to reduce pain in OA patients. However, it is unclear whether footwear interventions are able to alleviate the risk factors associated with the progression of OA following a meniscal injury. For effective self-management, post operation the appropriate footwear is recommended, however there is little evidence to inform what the appropriate footwear is for patient after surgery or with knee OA.
Current evidence on footwear interventions on minimising OA development relies on assessment of linear movements such as walking and running. Yet, it is likely that athletes who sustain a meniscal injury would return to sport and therefore be required to perform movements that require a greater demand and muscular control then reported during walking. It is unclear whether footwear interventions are able to alleviate the risk factors associated with the progression of OA following a meniscal injury in a younger athletic population. Understanding knee loading during sport-specific movements and between sports footwear can provide a greater insight to the risk of OA development for athletic populations. Therefore understanding the effect of commercially available footwear interventions knee loading during sport-specific movements could provide a greater insight to the use conservative interventions to reducing the risk of OA development for athletic populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Testing meniscus patients for several different shoes
| Arm | Type | Receives |
|---|---|---|
| Meniscus Injured | Experimental | Device: FootwearThese meniscus patients will be recruited to participate in a single session to wear 4 different pairs of shoes |
| Footwear | Experimental | Procedure: Gait analysis4 Different types of trainers will be used to see the difference in gait in meniscectomy patients |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 18 and 40 years
- Compete and or play sport a minimum two times a week
- Able to perform sport specific tasks including running, single leg landing and small knee bend squat
- Meniscectomy group - has had a meniscectomy surgery following a traumatic meniscal injury during a sporting task.
Key exclusion criteria (4 listed)
- History of lower extremity surgeries (other than a meniscectomy) e.g. ACL reconstruction
- Evidence of knee osteoarthritis development either assessed clinically (based on ACR criteria) or radiographically (Kellgren-Lawrence grade >1)
- Previous history of traumatic (other than the sustained meniscal injury), inflammatory or infectious pathology in the lower extremity
- Evidence of ligament laxity
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 |
|---|---|---|
| FootwearDifferent types of footwear will be tested to see if these can be used to help slow the progression of osteoarthritis in meniscectomy patients or even stop it from occurring. | Device | Meniscus Injured |
| Gait analysisGait analysis will be done during several different tasks wear the footwear | Procedure or surgery | Footwear |
Primary outcome
Biomechanical analysis using 3D motion capture looking at kinematics and kinetics
Time frame: Change from Baseline until 1 year
Knee adduction moment curve (different peaks) will be assessed for differences between conditions.
Electromyography analysis of muscle co-contraction
Time frame: Change from Baseline until 1 year
The co-activation of quadriceps and hamstrings will be analysed using EMG. EMG will first be normalized using MVC and then the co-contraction will be analysed.
Biomechanical analysis using 3D motion capture looking at kinematics and kinetics
Time frame: Change from Baseline until 1 year
Knee adduction angular impulse (the area under the curve) will be assessed for differences between conditions.
4 secondary outcomes
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: Change from Baseline until 1 year
Patient-perceived global change in pain
Time frame: Change from Baseline until 1 year
Tampa Scale of Kinesiophobia (TSK)
Time frame: Change from Baseline until 1 year
Comfort Rating Questionnaire
Time frame: Change from Baseline until 1 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 3 Nov 2020.
- Derived from this study: PubMed 38524891Starbuck C, Walters V, Herrington L, Barkatali B, Jones R. Knee Offloading by Patients During Walking and Running After Meniscectomy. Orthop J Sports Med. 2024 Mar 21;12(3):23259671231214766. doi: 10.1177/23259671231214766. eCollection 2024 Mar.
- Individual participant dataSharing planned: No. The research data will only be shared in the research team participating in this study.
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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?
A study testing Footwear and Gait analysis in people with Meniscus Injury and Osteoarthritis, Knee, run by University of Salford 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 4 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 3 Nov 2020. 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?
Biomechanical analysis using 3D motion capture looking at kinematics and kinetics (time frame: Change from Baseline until 1 year). 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?
On the ClinicalTrials.gov record for NCT03379415, which also lists 1 linked publication.
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 3 Nov 2020.