Knee OsteoarthritisNCT00492674
The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty
A study testing APOS biomechanical gait system and Physical Therapy in people with Knee Osteoarthritis, run by Assaf-Harofeh Medical Center.
Trial summary
Introduction: Total knee arthroplasty (TKA) is a consensus treatment for end-stage knee osteoarthritis. The peri-operative rehabilitation is an important part of the outcome of such procedure. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- APOS biomechanical gait system and Physical Therapy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for total knee arthroplasty (d/t osteoarthritis)
- All operated by the same Surgeons (Prof. Nahum Halperin's group)
- Identical kind of Prosthesis in use (zimmer Lps-Flex Mobile)
Who cannot join
- Prior joint arthroplasty
- A pathology in additional segment (ankle, hip)
- Other muscular or neurological disease/condition
- Mentally or physically impairment that will prevent the patinet from proper use of the biomechanical device.
About this study
Official title: The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty: A Double Blind Randomized Prospective Study
Introduction: Total knee arthroplasty (TKA) is a consensus treatment for end-stage knee osteoarthritis. The peri-operative rehabilitation is an important part of the outcome of such procedure. Previous studies have shown that there is correlation between both pre-operative functional status and the intensiveness of the post-operative rehabilitation to the post operative function of the patient.
An important part of the peri-operative rehabilitation in TKA is the neuromuscular control re-education.
Read more
A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed. This device is capable of bringing the patient to a functional bio-mechanical alignment during standing and walking, while simultaneously strengthening dynamic stabilizers and training neuromuscular control by means of controlled biomechanical perturbations.
Objectives: The aim of this study is to evaluate the influence of pre and post operative training with the biomechanical device mentioned above on the functional outcome and quality of life of patients undergoing TKA.
Design and Setting: Randomized, controlled and double blind prospective trial
Patients: 120 patients who are candidates to TKA
Interventions: Patients will randomly assigned into five groups (active, sham and control) and will followed for fourteen months (two moths pre-operative and twelve months post-operative). All groups will undergo post-operative physical therapy (PT) according to the standard guidelines. In addition, the active groups will be treated with the device and its four biomechanical elements that had been individually calibrated for each patient. The sham group will be treated with the same device; however, the biomechanical elements will have zero perturbation and will be positioned along the central longitudinal line of the shoe-platform. The control group will be treated only according to the standard post-operative protocol.
The five groups:
- Pre- operative BD training and post-operative PT and BD training
- Pre- operative sham training and post-operative PT and BD training
- Pre- operative sham training and post-operative PT and sham training
- No pre-operative training (according to the guidelines in Israel) and post-operative PT and BD training.
- No pre-operative training (according to the guidelines in Israel) and post-operative PT and sham training.
Primary Outcome Measures: Spatio-temporal measures (recorded by Gait-Rite™) and the Aggregated Locomotor Function (ALF) assessment.
Secondary Outcome Measures: Pain and function questionnaire measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Quality of life will be evaluated by the SF-36 quality of life questionnaire.
Measurements will be taken at day-1 (two months before the TKA) and at four more stations: 1 Week prior to the TKA, Three months post the TKA, six months post the TKA and twelve months post the TKA
Read the detailed description
Introduction: Total knee arthroplasty (TKA) is a consensus treatment for end-stage knee osteoarthritis. The peri-operative rehabilitation is an important part of the outcome of such procedure. Previous studies have shown that there is correlation between both pre-operative functional status and the intensiveness of the post-operative rehabilitation to the post operative function of the patient.
An important part of the peri-operative rehabilitation in TKA is the neuromuscular control re-education.
A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed. This device is capable of bringing the patient to a functional bio-mechanical alignment during standing and walking, while simultaneously strengthening dynamic stabilizers and training neuromuscular control by means of controlled biomechanical perturbations.
Objectives: The aim of this study is to evaluate the influence of pre and post operative training with the biomechanical device mentioned above on the functional outcome and quality of life of patients undergoing TKA.
Design and Setting: Randomized, controlled and double blind prospective trial
Patients: 120 patients who are candidates to TKA
Interventions: Patients will randomly assigned into five groups (active, sham and control) and will followed for fourteen months (two moths pre-operative and twelve months post-operative). All groups will undergo post-operative physical therapy (PT) according to the standard guidelines. In addition, the active groups will be treated with the device and its four biomechanical elements that had been individually calibrated for each patient. The sham group will be treated with the same device; however, the biomechanical elements will have zero perturbation and will be positioned along the central longitudinal line of the shoe-platform. The control group will be treated only according to the standard post-operative protocol.
The five groups:
- Pre- operative BD training and post-operative PT and BD training
- Pre- operative sham training and post-operative PT and BD training
- Pre- operative sham training and post-operative PT and sham training
- No pre-operative training (according to the guidelines in Israel) and post-operative PT and BD training.
- No pre-operative training (according to the guidelines in Israel) and post-operative PT and sham training.
Primary Outcome Measures: Spatio-temporal measures (recorded by Gait-Rite™) and the Aggregated Locomotor Function (ALF) assessment.
Secondary Outcome Measures: Pain and function questionnaire measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Quality of life will be evaluated by the SF-36 quality of life questionnaire.
Measurements will be taken at day-1 (two months before the TKA) and at four more stations: 1 Week prior to the TKA, Three months post the TKA, six months post the TKA and twelve months post the TKA
- Conditions
- Knee Osteoarthritis
- Being tested
- APOS biomechanical gait system, Physical Therapy
- Keywords
- TKA, Arthroplasty, Knee, Osteoarthritis, Rehabilitation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APOS biomechanical gait systemDevice
Physical TherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Nahum Halperin, MD, Principal investigator, Asaf-Harofeh Medical CenterZeevi Dvir, PhD, Study chair, Tel Aviv UniversityNoga Gal, Msc, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492674
- Sponsor's protocol ID
- 35/07
- Status last verified
- Apr 2007
- First submitted
- 26 Jun 2007
- Last updated
- 27 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty: A Double Blind Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00492674
- Acronym / sponsor ID
- 35/07
- Conditions
- Knee Osteoarthritis
- Keywords
- TKA, Arthroplasty, Knee, Osteoarthritis, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- First posted
- 27 Jun 2007 (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.
Introduction: Total knee arthroplasty (TKA) is a consensus treatment for end-stage knee osteoarthritis. The peri-operative rehabilitation is an important part of the outcome of such procedure. Previous studies have shown that there is correlation between both pre-operative functional status and the intensiveness of the post-operative rehabilitation to the post operative function of the patient.
An important part of the peri-operative rehabilitation in TKA is the neuromuscular control re-education.
A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed. This device is capable of bringing the patient to a functional bio-mechanical alignment during standing and walking, while simultaneously strengthening dynamic stabilizers and training neuromuscular control by means of controlled biomechanical perturbations.
Objectives: The aim of this study is to evaluate the influence of pre and post operative training with the biomechanical device mentioned above on the functional outcome and quality of life of patients undergoing TKA.
Design and Setting: Randomized, controlled and double blind prospective trial
Patients: 120 patients who are candidates to TKA
Interventions: Patients will randomly assigned into five groups (active, sham and control) and will followed for fourteen months (two moths pre-operative and twelve months post-operative). All groups will undergo post-operative physical therapy (PT) according to the standard guidelines. In addition, the active groups will be treated with the device and its four biomechanical elements that had been individually calibrated for each patient. The sham group will be treated with the same device; however, the biomechanical elements will have zero perturbation and will be positioned along the central longitudinal line of the shoe-platform. The control group will be treated only according to the standard post-operative protocol.
The five groups:
- Pre- operative BD training and post-operative PT and BD training
- Pre- operative sham training and post-operative PT and BD training
- Pre- operative sham training and post-operative PT and sham training
- No pre-operative training (according to the guidelines in Israel) and post-operative PT and BD training.
- No pre-operative training (according to the guidelines in Israel) and post-operative PT and sham training.
Primary Outcome Measures: Spatio-temporal measures (recorded by Gait-Rite™) and the Aggregated Locomotor Function (ALF) assessment.
Secondary Outcome Measures: Pain and function questionnaire measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Quality of life will be evaluated by the SF-36 quality of life questionnaire.
Measurements will be taken at day-1 (two months before the TKA) and at four more stations: 1 Week prior to the TKA, Three months post the TKA, six months post the TKA and twelve months post the TKA
Detailed description
Introduction: Total knee arthroplasty (TKA) is a consensus treatment for end-stage knee osteoarthritis. The peri-operative rehabilitation is an important part of the outcome of such procedure. Previous studies have shown that there is correlation between both pre-operative functional status and the intensiveness of the post-operative rehabilitation to the post operative function of the patient.
An important part of the peri-operative rehabilitation in TKA is the neuromuscular control re-education.
A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed. This device is capable of bringing the patient to a functional bio-mechanical alignment during standing and walking, while simultaneously strengthening dynamic stabilizers and training neuromuscular control by means of controlled biomechanical perturbations.
Objectives: The aim of this study is to evaluate the influence of pre and post operative training with the biomechanical device mentioned above on the functional outcome and quality of life of patients undergoing TKA.
Design and Setting: Randomized, controlled and double blind prospective trial
Patients: 120 patients who are candidates to TKA
Interventions: Patients will randomly assigned into five groups (active, sham and control) and will followed for fourteen months (two moths pre-operative and twelve months post-operative). All groups will undergo post-operative physical therapy (PT) according to the standard guidelines. In addition, the active groups will be treated with the device and its four biomechanical elements that had been individually calibrated for each patient. The sham group will be treated with the same device; however, the biomechanical elements will have zero perturbation and will be positioned along the central longitudinal line of the shoe-platform. The control group will be treated only according to the standard post-operative protocol.
The five groups:
- Pre- operative BD training and post-operative PT and BD training
- Pre- operative sham training and post-operative PT and BD training
- Pre- operative sham training and post-operative PT and sham training
- No pre-operative training (according to the guidelines in Israel) and post-operative PT and BD training.
- No pre-operative training (according to the guidelines in Israel) and post-operative PT and sham training.
Primary Outcome Measures: Spatio-temporal measures (recorded by Gait-Rite™) and the Aggregated Locomotor Function (ALF) assessment.
Secondary Outcome Measures: Pain and function questionnaire measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Quality of life will be evaluated by the SF-36 quality of life questionnaire.
Measurements will be taken at day-1 (two months before the TKA) and at four more stations: 1 Week prior to the TKA, Three months post the TKA, six months post the TKA and twelve months post the TKA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidates for total knee arthroplasty (d/t osteoarthritis)
- All operated by the same Surgeons (Prof. Nahum Halperin's group)
- Identical kind of Prosthesis in use (zimmer Lps-Flex Mobile)
Key exclusion criteria (4 listed)
- Prior joint arthroplasty
- A pathology in additional segment (ankle, hip)
- Other muscular or neurological disease/condition
- Mentally or physically impairment that will prevent the patinet from proper use of the biomechanical device.
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 |
|---|---|---|
| APOS biomechanical gait system | Device | – |
| Physical Therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2007.
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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.
Nahum Halperin, MD principal investigator
Asaf-Harofeh Medical Center
Zeevi Dvir, PhD study chair
Tel Aviv University
Noga Gal, Msc principal investigator
Tel Aviv University
Questions about this trial
What is this clinical trial studying?
A study testing APOS biomechanical gait system and Physical Therapy in people with Knee Osteoarthritis, run by Assaf-Harofeh Medical Center.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 27 Jun 2007.