Knee OsteoarthritisPhase 3KneehabTKANCT01096524
Effects of Kneehab 12-week Peri-operative Total Knee Arthroplasty
A Phase 3 study testing Standard Physiotherapy and Kneehab in people with Knee Osteoarthritis and Disuse Atrophy, run by Bio-Medical Research, Ltd. at 1 site in United Kingdom.
Trial summary
Determine the efficacy of neuromuscular electrical stimulation (NMES, Kneehab) in promoting accelerated recovery of quadriceps function in patients recovering from total knee arthroplasty (TKA) as measured by increases in isometric strength of the knee extensors and scores in the Timed Up and Go (TUG) test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Disuse Atrophy
- What is being tested?
- Standard Physiotherapy and Kneehab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Jun 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are scheduled for elective Total Knee Replacement surgery
- Individuals who are at least 18 years of age
- Individuals with a body mass index (BMI) <40
- Individuals who are walking independently with or without assistive devices
- Must be able and willing to complete all study assessments and to be followed for the full course of the study.
- Must be able to read, write and follow instructions in English.
- Must be able and willing to provide informed consent.
- Must be willing and able to attend for pre-op assessment
Who cannot join
- Individuals who have failed the pre-operative assessment
- Individuals with a history of foot and/or ankle pathology
- Individuals with a history of tibial or femoral fractures
- Individuals with a history of underlying neurological conditions
- Individuals with physical conditions which would make them unable to perform study procedures
- Individuals with a total hip replacement
Show all 16Show fewer
- Individuals undergoing revision TKA of the same operated leg
- Pregnant women or inadequate precautions to prevent pregnancy
- Diagnosis of a medical condition that would contraindicate treatment with the product,e.g skin lesions at electrode site.
- Individuals with an active implanted medical device (i.e. pacemaker, pump)
- Individuals with a history of stroke
- Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.)
- Individuals with a diagnosis of inflammatory arthritis (including Rheumatoid Arthritis, gout or psoriatic arthritis)
- Individuals with muscle disease (i.e. muscular dystrophy)
- Visible skin injury or disease on their legs
- Principal investigator for this study, or member of study staff
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool and Broadgreen University Hospital NHS Trust
Liverpool, Liverpool, L7 8XP
About this study
Official title: Phase III Study Investigating the Effects of 6-weeks of Neuromuscular Electrical Stimulation (NMES) Peri-total Knee Arthroplasty (TKA).
Determine the efficacy of neuromuscular electrical stimulation (NMES, Kneehab) in promoting accelerated recovery of quadriceps function in patients recovering from total knee arthroplasty (TKA) as measured by increases in isometric strength of the knee extensors and scores in the Timed Up and Go (TUG) test.
Read the detailed description
Knee osteoarthritis is a severe debilitating condition that greatly impacts patient quality of life, function, emotional well-being and everyday pain levels. Total knee arthroplasty (TKA) is performed as a means of alleviating these symptoms in the long term however short term muscle weakness following surgery can elicit its own detrimental effect on performance and activities of daily living. This underlines the importance of mitigating strength loss in the immediate post-operative period.
Recent reviews suggest that Neuromuscular Electrical Stimulation (NMES) of the quadriceps femoris muscle can be beneficial in the rehabilitation period following knee surgery. It appears that early use of NMES can help to recover exercise capacity in the muscle, thus allowing the patient to benefit more from volitional exercise therapy later in the rehabilitation period1. This in turn can lead to accelerated recovery and improved outcomes. A recent and as yet unpublished study of 96 patients following ACL reconstruction has demonstrated a clear benefit to the use of Kneehab. The benefit seemed to accrue in the six-week post-operative period.
A recent pilot study by Walls 2 also suggests that NMES applied in the immediate pre-operative period before TKA leads to increased muscle strength and improved functional abilities. Previously, Mizner (2005) has shown pre operative strength to be a good predictor of functional outcome 1 year after surgery3. This proposed study aims to examine whether NMES applied in the peri-operative timeframe, 6 weeks before and 6 weeks after, can improve outcomes for patients undergoing total knee replacement. The rationale for this approach is that NMES can help prepare the quadriceps muscle for the rehabilitation phase by building exercise capacity before the operation. The immediate deficit, which normally follows knee surgery, would therefore be compensated to some extent and the post-operative NMES treatment would be expected to counteract the activation inhibition that is thought to occur in the early weeks following surgery. Overall, the patient would be in a better position to benefit from conventional rehabilitation exercises aimed at improved co-ordination and functional performance.
- Conditions
- Knee Osteoarthritis, Disuse Atrophy
- Being tested
- Standard Physiotherapy, Kneehab
- Keywords
- Kneehab, NMES, Total Knee Arthroplasty, Total Knee Replacement, TKA, Disuse atrophy, muscle hypertrophy, TKR, Atrophy Prevention
- Medical subject headings
- Osteoarthritis, Knee, Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PhysiotherapyOther
The Control group will complete the standard physiotherapy care pre and post-TKA surgery without NMES.
KneehabDevice
Also called Neuromuscular Electrical Stimulation, NMES
NMES 2 x 20 minute sessions/day, 5 days/week, 6 weeks pre and 6 weeks post TKA.
Kneehab™ (Bio-Medical Research, Ltd., Galway, Ireland) is a NMES device with Multipath™ technology, designed to activate the quadriceps muscle. Kneehab™ is a battery operated, portable, 2-channel cutaneous electrical muscle stimulator, which operates using constant current pulses to stimulate the nerves innervating the quadriceps muscle. Kneehab™, consists of a thigh wrap with anatomically shaped electrodes and a control unit. Electrodes are placed over the quadriceps muscles and the garment is wrapped around the leg above the knee. Brief electrical impulses are delivered through the skin surface adhesive electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Control group standard physiotherapy | Other | Standard pathway of care pre-and post-TKA without using NMES. Receives: Other: Standard Physiotherapy |
| Kneehab | Experimental | Kneehab on the quadriceps of the affected leg, 20 minutes, twice per day, 5 days per week over 12-week intervention (6 weeks pre-op, 6 weeks post op). Receives: Device: Kneehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Kneehab in promoting early recovery of quadriceps performance following knee arthoplasty.
Isometric muscle strength of the knee extensors will be measured by dynamometer with the knee flexed to 60°.
Functional ability will be measured using the Timed Get Up and Go (TUG) and Stair Climb Test (SCT).
Measured: 6 weeks Pre-Op and 6, 12 and 52 weeks post op.
Secondary outcomes (1)
Determine the effect of Kneehab in promoting quality of life measures and health economic outcomes, compared to controls.
Administration of the Western Ontario McMaster University Osteoarthritis Index (WOMAC) and The Medical Outcomes Survey (SF-12). Health economic data will include patient length of stay post surgery; number of outpatient physiotherapy visits in the following year, and change in analgesic medication use during the 6 weeks pre- and 12 weeks post surgery.
Measured: 6 Weeks pre-Op and 6, 12 and 52 weeks post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-Medical Research, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alasdair Santini, M.D., Principal investigator, Royal Liverpool & Broadgreen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096524
- Sponsor's protocol ID
- BMR-09-1007
- Other IDs
- 2008-008483-27, 2008
- Acronym
- KneehabTKA
- Status last verified
- Aug 2013
- First submitted
- 24 Mar 2010
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Paillard T. Combined application of neuromuscular electrical stimulation and voluntary muscular contractions. Sports Med. 2008;38(2):161-77. doi: 10.2165/00007256-200838020-00005.
PubMed 18201117Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9.
PubMed 16078331Stevens JE, Mizner RL, Snyder-Mackler L. Quadriceps strength and volitional activation before and after total knee arthroplasty for osteoarthritis. J Orthop Res. 2003 Sep;21(5):775-9. doi: 10.1016/S0736-0266(03)00052-4.
PubMed 12919862Kennedy DM, Stratford PW, Hanna SE, Wessel J, Gollish JD. Modeling early recovery of physical function following hip and knee arthroplasty. BMC Musculoskelet Disord. 2006 Dec 11;7:100. doi: 10.1186/1471-2474-7-100.
PubMed 17156487
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study Investigating the Effects of 6-weeks of Neuromuscular Electrical Stimulation (NMES) Peri-total Knee Arthroplasty (TKA).
- ClinicalTrials.gov ID
- NCT01096524
- Acronym / sponsor ID
- KneehabTKA / BMR-09-1007
- Conditions
- Knee Osteoarthritis, Disuse Atrophy
- Keywords
- Kneehab, NMES, Total Knee Arthroplasty, Total Knee Replacement, TKA, Disuse atrophy, muscle hypertrophy, TKR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bio-Medical Research, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Study start
- Mar 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 Mar 2010 (estimated)
- 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.
Determine the efficacy of neuromuscular electrical stimulation (NMES, Kneehab) in promoting accelerated recovery of quadriceps function in patients recovering from total knee arthroplasty (TKA) as measured by increases in isometric strength of the knee extensors and scores in the Timed Up and Go (TUG) test.
Detailed description
Knee osteoarthritis is a severe debilitating condition that greatly impacts patient quality of life, function, emotional well-being and everyday pain levels. Total knee arthroplasty (TKA) is performed as a means of alleviating these symptoms in the long term however short term muscle weakness following surgery can elicit its own detrimental effect on performance and activities of daily living. This underlines the importance of mitigating strength loss in the immediate post-operative period.
Recent reviews suggest that Neuromuscular Electrical Stimulation (NMES) of the quadriceps femoris muscle can be beneficial in the rehabilitation period following knee surgery. It appears that early use of NMES can help to recover exercise capacity in the muscle, thus allowing the patient to benefit more from volitional exercise therapy later in the rehabilitation period1. This in turn can lead to accelerated recovery and improved outcomes. A recent and as yet unpublished study of 96 patients following ACL reconstruction has demonstrated a clear benefit to the use of Kneehab. The benefit seemed to accrue in the six-week post-operative period.
A recent pilot study by Walls 2 also suggests that NMES applied in the immediate pre-operative period before TKA leads to increased muscle strength and improved functional abilities. Previously, Mizner (2005) has shown pre operative strength to be a good predictor of functional outcome 1 year after surgery3. This proposed study aims to examine whether NMES applied in the peri-operative timeframe, 6 weeks before and 6 weeks after, can improve outcomes for patients undergoing total knee replacement. The rationale for this approach is that NMES can help prepare the quadriceps muscle for the rehabilitation phase by building exercise capacity before the operation. The immediate deficit, which normally follows knee surgery, would therefore be compensated to some extent and the post-operative NMES treatment would be expected to counteract the activation inhibition that is thought to occur in the early weeks following surgery. Overall, the patient would be in a better position to benefit from conventional rehabilitation exercises aimed at improved co-ordination and functional performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group standard physiotherapy | Other | Other: Standard PhysiotherapyStandard pathway of care pre-and post-TKA without using NMES. |
| Kneehab | Experimental | Device: KneehabKneehab on the quadriceps of the affected leg, 20 minutes, twice per day, 5 days per week over 12-week intervention (6 weeks pre-op, 6 weeks post op). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals who are scheduled for elective Total Knee Replacement surgery
- Individuals who are at least 18 years of age
- Individuals with a body mass index (BMI) <40
- Individuals who are walking independently with or without assistive devices
- Must be able and willing to complete all study assessments and to be followed for the full course of the study.
Key exclusion criteria (16 listed)
- Individuals who have failed the pre-operative assessment
- Individuals with a history of foot and/or ankle pathology
- Individuals with a history of tibial or femoral fractures
- Individuals with a history of underlying neurological conditions
- Individuals with physical conditions which would make them unable to perform study procedures
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 |
|---|---|---|
| Standard PhysiotherapyThe Control group will complete the standard physiotherapy care pre and post-TKA surgery without NMES. | Other | Control group standard physiotherapy |
| KneehabAlso: Neuromuscular Electrical Stimulation, NMESNMES 2 x 20 minute sessions/day, 5 days/week, 6 weeks pre and 6 weeks post TKA. Kneehab™ (Bio-Medical Research, Ltd., Galway, Ireland) is a NMES device with Multipath™ technology, designed to activate the quadriceps muscle. Kneehab™ is a battery operated, portable, 2-channel cutaneous electrical muscle stimulator, which operates using constant current pulses to stimulate the nerves innervating the quadriceps muscle. Kneehab™, consists of a thigh wrap with anatomically shaped electrodes and a control unit. Electrodes are placed over the quadriceps muscles and the garment is wrapped around the leg above the knee. Brief electrical impulses are delivered through the skin surface adhesive electrodes. | Device | Kneehab |
Primary outcome
Efficacy of Kneehab in promoting early recovery of quadriceps performance following knee arthoplasty.
Time frame: 6 weeks Pre-Op and 6, 12 and 52 weeks post op.
Isometric muscle strength of the knee extensors will be measured by dynamometer with the knee flexed to 60°. Functional ability will be measured using the Timed Get Up and Go (TUG) and Stair Climb Test (SCT).
1 secondary outcome
Determine the effect of Kneehab in promoting quality of life measures and health economic outcomes, compared to controls.
Time frame: 6 Weeks pre-Op and 6, 12 and 52 weeks post-Op
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 21 Jul 2014.
- Background: PubMed 18201117Paillard T. Combined application of neuromuscular electrical stimulation and voluntary muscular contractions. Sports Med. 2008;38(2):161-77. doi: 10.2165/00007256-200838020-00005.
- Background: PubMed 16078331Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9.
- Background: PubMed 12919862Stevens JE, Mizner RL, Snyder-Mackler L. Quadriceps strength and volitional activation before and after total knee arthroplasty for osteoarthritis. J Orthop Res. 2003 Sep;21(5):775-9. doi: 10.1016/S0736-0266(03)00052-4.
- Background: PubMed 17156487Kennedy DM, Stratford PW, Hanna SE, Wessel J, Gollish JD. Modeling early recovery of physical function following hip and knee arthroplasty. BMC Musculoskelet Disord. 2006 Dec 11;7:100. doi: 10.1186/1471-2474-7-100.
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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.
Alasdair Santini, M.D. principal investigator
Royal Liverpool & Broadgreen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Physiotherapy and Kneehab in people with Knee Osteoarthritis and Disuse Atrophy, run by Bio-Medical Research, Ltd. 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 8 inclusion and 16 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 21 Jul 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy of Kneehab in promoting early recovery of quadriceps performance following knee arthoplasty. (time frame: 6 weeks Pre-Op and 6, 12 and 52 weeks post op.). 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 NCT01096524, which also lists 4 linked publications.
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 21 Jul 2014.