Meniscus InjuryBOOMNCT03350204
Biomechanical Osteoarthritis Outcomes in Meniscectomy Patients
A study testing Meniscectomy in people with Meniscus Injury and Meniscectomy, run by University of Salford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniscus Injury, Meniscectomy, Osteoarthritis, Knee
- What is being tested?
- Meniscectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2017to 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 40 years
- Meniscal injury sustained during a sporting task e.g. a sports cutting manoeuvre (Football, Basketball, Netball, Hockey etc.)
- 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
- Medial or a lateral meniscal tear and listed for surgery
- Surgery in the last 12 months for meniscal injury (Meniscectomy or Meniscal Repair)
Who cannot join
- History of lower extremity surgeries e.g. ACL reconstruction (other than meniscal injury)
- 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
- Degenerative aspects including tear
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: Biomechanical Outcomes Associated With Osteoarthritis Progression in Meniscectomy Patients During Athletic and Functional Tasks (BOOM Study)
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.
Read the detailed 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.
- Conditions
- Meniscus Injury, Meniscectomy, Osteoarthritis, Knee
- Being tested
- Meniscectomy, Helathy control comparison
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeniscectomyProcedure or surgery
This will be to see what occurs in both kinetics and kinematics after you have a surgery and how this links on to osteoarthritis
Helathy control comparisonOther
This group will be used to get a baseline for normal and natural walking, running and other several tasks which will be used as a comparison for the meniscus injury group.
| Study group | Role | What they receive |
|---|---|---|
| Meniscus Injured | Experimental | These participants will come in pre and post operation Receives: Procedure: Meniscectomy |
| Healthy | Experimental | These participants will be used as a standardised comparison for the patient group Receives: Other: Helathy control comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanics
All sections of the knee adduction moment curve (different peaks) and also the knee adduction angular impulse (the area under the curve) will be assessed for differences between conditions. Magnitudes and durations of three muscle co-contractions will be calculated from the surface EMG data
Measured: Immediate
Secondary outcomes (3)
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 subscale with a score of 100 indicting no symptoms, whilst 0 indicates extreme symptoms.
Measured: Immediate
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: Immediate
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: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Nov 2017
- 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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Testing both meniscus patients and uninjured individuals for comparison
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 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
- NCT03350204
- Sponsor's protocol ID
- HSR1617-56
- Acronym
- BOOM
- Status last verified
- Nov 2020
- First submitted
- 17 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.
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
- Biomechanical Outcomes Associated With Osteoarthritis Progression in Meniscectomy Patients During Athletic and Functional Tasks (BOOM Study)
- ClinicalTrials.gov ID
- NCT03350204
- Acronym / sponsor ID
- BOOM / HSR1617-56
- Conditions
- Meniscus Injury, Meniscectomy, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 22 Nov 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.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Testing both meniscus patients and uninjured individuals for comparison
| Arm | Type | Receives |
|---|---|---|
| Meniscus Injured | Experimental | Procedure: MeniscectomyThese participants will come in pre and post operation |
| Healthy | Experimental | Other: Helathy control comparisonThese participants will be used as a standardised comparison for the patient group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18 and 40 years
- Meniscal injury sustained during a sporting task e.g. a sports cutting manoeuvre (Football, Basketball, Netball, Hockey etc.)
- 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
- Medial or a lateral meniscal tear and listed for surgery
Key exclusion criteria (5 listed)
- History of lower extremity surgeries e.g. ACL reconstruction (other than meniscal injury)
- 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
- Degenerative aspects including tear
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 |
|---|---|---|
| MeniscectomyThis will be to see what occurs in both kinetics and kinematics after you have a surgery and how this links on to osteoarthritis | Procedure or surgery | Meniscus Injured |
| Helathy control comparisonThis group will be used to get a baseline for normal and natural walking, running and other several tasks which will be used as a comparison for the meniscus injury group. | Other | Healthy |
Primary outcome
Biomechanics
Time frame: Immediate
All sections of the knee adduction moment curve (different peaks) and also the knee adduction angular impulse (the area under the curve) will be assessed for differences between conditions. Magnitudes and durations of three muscle co-contractions will be calculated from the surface EMG data
3 secondary outcomes
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: Immediate
Patient-perceived global change in pain
Time frame: Immediate
Tampa Scale of Kinesiophobia (TSK)
Time frame: Immediate
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.
- 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 Meniscectomy in people with Meniscus Injury and Meniscectomy, 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 6 inclusion and 5 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?
Biomechanics (time frame: Immediate). 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 3 Nov 2020.