Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03350204 |
| Other study ID # |
HSR1617-56 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2017 |
| 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
The key aim of this study is to examine biomechanical measures associated with osteoarthritis
(OA) progression in patients who have lateral and medial menisci injuries during various
tasks. The likelihood is that individuals who have a meniscal injury often develop knee
osteoarthritis. Therefore understanding biomechanical changes from the injury, specifically
undertaking both functional and sporting activities, may provide a conservative approach to
delaying or minimising the development of OA. Three-dimensional kinetic and kinematic
measures will be assessed during seven tasks (walking, running, side cuts, single leg
landing, small knee bend squat and isokinetic leg strength), prior to and following
treatment. In addition, Strength and balance will be assessed to indicate if there is more
work in the rehabilitation program that is needed for functional movement.
Description:
Injuries to the meniscus are common in sport, often as a result of a traumatic event (Englund
et al., 2016; Stanley et al., 2016; Yeh et al., 2012). 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,
with the lateral meniscus taking as much as 70% of the load in the lateral compartment and
the medial meniscus carrying approximately 50% of the medial load (Fox et al., 2015; Kurosawa
et al., 1980). The lateral meniscus is of particular importance in young active people,
especially in athletes and sportsmen. The geometries of the medial and lateral compartments
differ significantly (McDermott, 2011).
Damage to the meniscus is suggest to lead to altered knee mechanics leading to the initiation
or acceleration of osteoarthritis (OA) development (Badlani et al., 2013; Englund et al.,
2016). Prior meniscal tears are commonly reported in OA patients (Bhattacharyya et al.,
2003), in addition, reports suggest 4 to 14 times increased risk of developing OA following a
meniscal injury (Gelber et al., 2000; Kujala et al., 1995).
Altered knee mechanics have been reported following a meniscal injury, which have been
associated with increased likelihood of developing OA, the exact affects differ however
depending on which compartment of the meniscus has been operated (Hulet et al., 2014). These
changes include reduced contact area within the joint and increased contact pressure,
resulting in reduced ability to transmit load (Badlani et al., 2013). Indirect measures of
knee loading, such as external knee adductor moments and knee adduction angular impulses
(KAAI), have been associated with increased risk of developing OA (Chang et al., 2014). Knee
joint loading is also determined by the coordination of muscle activity (Schmitt & Rudolph,
2008). 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 (Hodges et al., 2016).
Meniscectomies are widely used to manage the symptoms associated with meniscus injuries
(McDermott, 2011). Whilst, non-operative therapies have demonstrated improvements in knee
pain three years post intervention (Rimington et al., 2009). However, following these
interventions, alter mechanics of the knee have been observed (Badlani et al., 2013; Edd et
al., 2015; Willy et al., 2016). 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 (Bae et al., 2012). As many athletic individuals with a meniscal
lesion undergo partial meniscectomy with the goal of returning to sports participation,
knowledge of knee joint loads during such activities are important and under researched and
may inform effective rehabilitation measures (Willy et al., 2016). Due to reduced
tibiofemoral contact area, a knee that has undergone a partial meniscectomy has a diminished
capacity to manage loads (Atmaca et al., 2013). Meniscectomy patients have demonstrated
increased external knee adduction moment (EKAM) three months post operation (Hall et al.,
2014), this increase could explain the increase risk of OA progression reported in these
patients. Medial compartment knee osteoarthritis is often initiated by changes in knee joint
motions and increased contact forces, such as those following meniscal injuries. The external
knee adduction moment (EKAM) has been identified as a surrogate measure for medial contact
force during gait, with an abnormally large peak value being linked to increased pain and
rate of disease progression (Walter et al., 2010). The external knee adduction moment
Increases in EKAM in meniscectomy patients have been associated with changes in tibia
alignment and ground reaction force (GRF) lever arm (Hall et al., 2014; Hunt et al., 2006).
Non-invasive interventions such as footwear, could alter biomechanics to lower EKAM and
reduce the progression of OA. However, firstly an understanding of the lower limb
biomechanics in these individuals is needed Despite the information about contributing
factors and underlying mechanisms of meniscus injuries and the progression to OA, there is
still a lack in current literature on specific movement patterns, rehabilitation strategies
and sport influences. For instance, majority of research examines walking with only Willy et
al. (2016) examining running. Typical sports movements such landing and cutting require
dynamic control of the knee which is very under-researched (Hall et al., 2015). 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 (Pietrosimone et al., 2016). Recent studies that analysed
both the peak force and rate to peak force development have shown that there is a significant
reduction in muscle strength post meniscectomy treatment (Eitzen et al., 2009). This is
considered to be clinically relevant for the return to sport criteria, as most meniscectomy
patients have been seen to have a 25% strength difference between legs (Hall et al., 2013),
however for patients with knee injuries this difference is often capped at 10% difference
between legs to return to their sports (Grindem et al., 2016). Muscle strength is also
essential to control movements such as stair descent which is essential for everyday living
(Rudolph and Snyder-Mackler., 2004). This is closely linked with balance and the risk of
falling. The current literature shows a large variability in assessment methods and results.
However, no assessment in isolation can provide a full picture of the problem. A combination
of assessment tools seems crucial, since it enables the supply of a full picture meniscus
injuries and coping mechanisms. By means of an integrated approach, underlying mechanisms of
meniscectomies can be identified, and the adequate treatments such as individualized
movements, activity levels and specific shoes can be identified. This should facilitate more
informed biomechanical outcomes conveying measures that can be implemented to diminish the
risks of OA in meniscectomy patients, in the hopes of improving and aiding their recovery
indefinitely.
