The Effect of Commercially Available Footwear Interventions in Meniscectomy Patients (MENI-FOOT)
The Effect of Commercially Available Footwear Interventions on Biomechanical Outcomes Associated With Knee Osteoarthritis in Meniscectomy Patients
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lancashire
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Manchester, Lancashire, United Kingdom, M11 2AZ
- Manchester Institute of Health and Performance
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Meniscus Injured
These meniscus patients will be recruited to participate in a single session to wear 4 different pairs of shoes
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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.
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Experimental: Footwear
4 Different types of trainers will be used to see the difference in gait in meniscectomy patients
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Gait analysis will be done during several different tasks wear the footwear
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Change from Baseline until 1 year
|
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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.
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Change from Baseline until 1 year
|
|
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.
|
Change from Baseline until 1 year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee injury and osteoarthritis outcome score (KOOS)
Time Frame: Change from Baseline until 1 year
|
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.
|
Change from Baseline until 1 year
|
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Patient-perceived global change in pain
Time Frame: Change from Baseline until 1 year
|
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).
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Change from Baseline until 1 year
|
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Tampa Scale of Kinesiophobia (TSK)
Time Frame: Change from Baseline until 1 year
|
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).
|
Change from Baseline until 1 year
|
|
Comfort Rating Questionnaire
Time Frame: Change from Baseline until 1 year
|
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).
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Change from Baseline until 1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- HSR1617-140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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