Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03379415 |
| Other study ID # |
HSR1617-140 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2018 |
| Est. completion date |
September 20, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
University of Salford |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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). 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.
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.
