OsteoarthritisPhase 1/2NCT00256958
Static and Dynamic Balance in Correlation With Quality of Life, in Primary Total Knee Replacement
A Phase 1/2 study testing total knee replacement in people with Osteoarthritis and Total Knee Replacement, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Knee osteoarthritis (OA) is one of the most prevalent musculoskeletal complaints worldwide, affecting 30-40% of the population by the age of 65 yr.Individuals with knee OA suffer progressive loss of function.Balance is an integral component of these and many other activities of daily living. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis, Total Knee Replacement
- What is being tested?
- total knee replacement
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2005to Jun 2007
- Phase
- Phase 1/2
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:During a year of prospective study we plan to recruit 150 participants with symptomatic OA of the knee, hospitalizing in orthopedic department of Hadassah Hospital for primary TKR. Confirmation of diagnosis of OA will be based on the American College of Rheumatology classification criteria . Participants have to be able to stand and to walk and also to follow simple instructions.
-
Exclusion Criteria:previous knee surgery, neurological problem with severe motor deficit (Parkinson disease, hemiplegia, spinal cord injury), severe orthopedic problem of low limbs (arthrodesis of low limb's joints, failed TKR/THR, amputation, failed back), systemic arthritic condition, severe cognitive problem with restricted consent.
-
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Static and Dynamic Balance During Standing and Walking in Correlation With Quality of Life, in Primary Total Knee Replacement
Knee osteoarthritis (OA) is one of the most prevalent musculoskeletal complaints worldwide, affecting 30-40% of the population by the age of 65 yr.Individuals with knee OA suffer progressive loss of function.Balance is an integral component of these and many other activities of daily living. Individuals with knee OA display impairment in postural control, mostly under dynamic testing condition. Total knee replacement (TKR) has an established place in the treatment of knee osteoarthritis and is considered to be an effective intervention.It remains unknown whether TKR impact significantly at balance state of the patients with OA and whether improving in functional abilities after TKR correlates with balance control ability in this population.The purpose of this study is to determine whether TKR have any effects on relatively new postural control measures using force platform system - Balance master, in correlation with functional balance assessment.
Methods:
Participants During a year of prospective study we plan to recruit 150 participants with symptomatic OA of the knee, hospitalizing in orthopedic department of Hadassah Hospital for primary TKR. Participants will undergo evaluation just before a surgery and a year after.They will be asked to perform Balance Master measurements, ambulation and balance tests. Additional information will be collected through a questionnaire and physical examination.
Read the detailed description
Balance Master Testing
The Pro Balance Master system with software version 8 will be used in the study. The Pro Balance Master system is comprised of two 23cm × 46cm dual force plates connected at the midline of the anterioposterior axis by a pin joint. Each force plate is mounted on a pair of symmetrically positioned force transducers. The four transducers measure vertical ground reaction forces, which form the basis of subsequent calculations of center of pressure (COP) and center of gravity (COG) sway angels. All test data are acquired and then stored on a PC.
Subjects are instructed to remove their shoes and step onto the forceplates, which have to be covered with tracing paper. Their feet are positioned by aligning the lateral border of the foot with the appropriate height line marked on the forceplates (ie, short, 76 to 140 cm; medium, 141 to 165cm; or tail, 166 to 203cm). The medial maileoli are aligned with the transverse forceplate line and subjects adopted a comfortable amount of forefoot splay. The outline of their feet is traced onto paper to ensure the same placement in subsequent testing sessions. The visual display monitor is adjusted to the subject's eye level. Subjects are instructed not to move their feet and are asked to stand with their arms at their sides throughout the testing procedure. The standard test suite protocol will be administered, consisting of 6 tests, 3 of which are static and 3 dynamic. The static tests require the subject to look straight ahead while standing as still as possible, initially with eyes open, then with eyes closed, and finally focusing on the display monitor using visual feedback to maintain the position of a cursor (representing the subject's COG) within a centrally positioned target box. For each test, data relating to postural sway is recorded for a period of 20 seconds and the area of the sway is calculated and expressed as a percentage of the subject's theoretical limits of stability (LOS). Assuming that movement about the ankle (with a fixed foot position) resembles an inverted pendulum, these limits are defined as extending 6.25 ° anteriorly, 4.45 ° posteriorly, and 8.00 ° to each side, ~2 and delimit the area over which the COG can safely move without changing the base of support.
All three dynamic tests require subjects to shift their COG. The first dynamic test involves rhythmic weight shifting side to side to 50% of the LOS at 3-second then 2-second pacing. Subjects are instructed to match the timing and movement of a bail on the screen by shifting their body weight side to side to target lines denoted on the screen. The second test is similar to the first except movement was now in an anterioposterior direction. Data reflecting the average magnitude of the movement path (expressed as a percentage of the LOS) are produced from six trials at each pace for each movement direction. The absolute error relative to the targets (set at 50% of the LOS) is calculated by subtracting 50 from the score obtained (50% indicating perfect execution) and recording it in absolute terms.
The final dynamic test involved weight shifting to 8 targets positioned in an ellipse, the perimeter of which corresponded to 75% of the LOS. The subjects are required to follow a ball to each target as it is highlighted, and remain at that target for 3 seconds before returning to the central target (neutral).
Targets are highlighted in random order, but each target is selected only once. The maximum allowable movement time to reach a target is 8 seconds. The average movement time and path sway (in terms of percentage of the LOS) is determined across targets. A score of 100% indicated that no path deviation had occurred, ie, perfect execution. (It should be noted that the processing of the data to produce the outcome measures described above is hard coded by NeuroCom.ª)
Main Outcome Measures:
Oxford Knee Score (OKS). The OKS is a self-completed patient based outcome score . It is a 12 item self-completed patient based outcome score. The questionnaire was developed from patient interview and validated against two generic health scales, the SF-36 and Health Assessment Questionnaire (HAQ) [44]. It was originally intended for use in large randomised controlled trials for patients undergoing total knee replacement, to assess levels of, and changes in, pain and function of the knee solely from the patient's viewpoint. Data collection can be via a postal questionnaire or by directed interview.
Visual Analog Scale (VAS).The severity of knee pain is evaluated by the VAS [45] after patients remain in a weight-bearing position (walking or standing) for 5 minutes in the parallel bars. The VAS instrument consisted of horizontal lines 10cm long, with anchor points of 0 (no pain) and 10 (maximum pain).
Four Square Step Test (FSST). FSST is a clinical measure of rapid stepping and obstacle avoidance . The equipment required for the FSST includes a stopwatch and 4 canes. The square is formed by using 4 canes resting flat on the floor. Canes are 90cm long, and the direction and type of handle used is not important. The subject stands in square number 1 facing square number 2. The aim is to step as fast as possible into each square in the following sequence. Square number 2, 3, 4, 1, 4, 3, 2, and 1. This sequence requires the subject to step forward, backward, and sideway to the right and left. The score is recorded as the time taken to complete the sequence. The stopwatch starts when the first foot contacts the floor in square 2 and finishes when the last foot comes back to touch the floor in square 1. The following instructions are given to the subject, "Try to complete the sequence as fast as possible without touching the sticks. Both feet must make contact with the floor in each square. If possible, face forward during the entire sequence." The sequence is then shown to the subject.
One practice trial is completed to ensure the subject knows the sequence. Two FSST are completed with the best time taken as the score. A trial is repeated if the subject fails to complete the sequence successfully, loses balance, or makes contact with a cane during the sequence. Subjects who were unable to face forward during the entire sequence and needed to turn before stepping into the next square were still given a score. All subjects wore their preferred shoes. The examiner stood in a position to see all steps taken by the subject, and an assistant provided the subject with close supervision. The entire test, including giving instructions and a practice trial, took less than 5 minutes to complete.
Time Up and Go test (TUG). Subjects are required to stand up from a chair with armrests, walk 3m, turn around, return to the chair, and sit down. The time taken to complete this task is measured in seconds with a stopwatch [47]. The TUG test showed a high degree of test-retest reliability in TUG scores in elderly subjects .
SF-36. This is a 36-item questionnaire which measures health functioning on eight scales, including a physical functioning scale, and is among the most widely used measures of quality of life in studies of patients and populations .Missing data and scoring procedures followed the SF-36 user guidelines .
- Conditions
- Osteoarthritis, Total Knee Replacement
- Being tested
- total knee replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee replacementProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Master Testing
Oxford Knee Score
Visual Analog Scale
Four Square Step Test
Time Up and Go test
Secondary outcomes (1)
SF-36.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startNov 2005
- Study completionJun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Isabella Schwartz, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256958
- Sponsor's protocol ID
- TKR-BM-HMO-CTIL
- Status last verified
- Nov 2005
- First submitted
- 20 Nov 2005
- Last updated
- 13 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Static and Dynamic Balance During Standing and Walking in Correlation With Quality of Life, in Primary Total Knee Replacement
- ClinicalTrials.gov ID
- NCT00256958
- Acronym / sponsor ID
- TKR-BM-HMO-CTIL
- Conditions
- Osteoarthritis, Total Knee Replacement
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Jun 2007 (estimated)
- First posted
- 22 Nov 2005 (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.
Knee osteoarthritis (OA) is one of the most prevalent musculoskeletal complaints worldwide, affecting 30-40% of the population by the age of 65 yr.Individuals with knee OA suffer progressive loss of function.Balance is an integral component of these and many other activities of daily living. Individuals with knee OA display impairment in postural control, mostly under dynamic testing condition. Total knee replacement (TKR) has an established place in the treatment of knee osteoarthritis and is considered to be an effective intervention.It remains unknown whether TKR impact significantly at balance state of the patients with OA and whether improving in functional abilities after TKR correlates with balance control ability in this population.The purpose of this study is to determine whether TKR have any effects on relatively new postural control measures using force platform system - Balance master, in correlation with functional balance assessment.
Methods:
Participants During a year of prospective study we plan to recruit 150 participants with symptomatic OA of the knee, hospitalizing in orthopedic department of Hadassah Hospital for primary TKR. Participants will undergo evaluation just before a surgery and a year after.They will be asked to perform Balance Master measurements, ambulation and balance tests. Additional information will be collected through a questionnaire and physical examination.
Detailed description
Balance Master Testing
The Pro Balance Master system with software version 8 will be used in the study. The Pro Balance Master system is comprised of two 23cm × 46cm dual force plates connected at the midline of the anterioposterior axis by a pin joint. Each force plate is mounted on a pair of symmetrically positioned force transducers. The four transducers measure vertical ground reaction forces, which form the basis of subsequent calculations of center of pressure (COP) and center of gravity (COG) sway angels. All test data are acquired and then stored on a PC.
Subjects are instructed to remove their shoes and step onto the forceplates, which have to be covered with tracing paper. Their feet are positioned by aligning the lateral border of the foot with the appropriate height line marked on the forceplates (ie, short, 76 to 140 cm; medium, 141 to 165cm; or tail, 166 to 203cm). The medial maileoli are aligned with the transverse forceplate line and subjects adopted a comfortable amount of forefoot splay. The outline of their feet is traced onto paper to ensure the same placement in subsequent testing sessions. The visual display monitor is adjusted to the subject's eye level. Subjects are instructed not to move their feet and are asked to stand with their arms at their sides throughout the testing procedure. The standard test suite protocol will be administered, consisting of 6 tests, 3 of which are static and 3 dynamic. The static tests require the subject to look straight ahead while standing as still as possible, initially with eyes open, then with eyes closed, and finally focusing on the display monitor using visual feedback to maintain the position of a cursor (representing the subject's COG) within a centrally positioned target box. For each test, data relating to postural sway is recorded for a period of 20 seconds and the area of the sway is calculated and expressed as a percentage of the subject's theoretical limits of stability (LOS). Assuming that movement about the ankle (with a fixed foot position) resembles an inverted pendulum, these limits are defined as extending 6.25 ° anteriorly, 4.45 ° posteriorly, and 8.00 ° to each side, ~2 and delimit the area over which the COG can safely move without changing the base of support.
All three dynamic tests require subjects to shift their COG. The first dynamic test involves rhythmic weight shifting side to side to 50% of the LOS at 3-second then 2-second pacing. Subjects are instructed to match the timing and movement of a bail on the screen by shifting their body weight side to side to target lines denoted on the screen. The second test is similar to the first except movement was now in an anterioposterior direction. Data reflecting the average magnitude of the movement path (expressed as a percentage of the LOS) are produced from six trials at each pace for each movement direction. The absolute error relative to the targets (set at 50% of the LOS) is calculated by subtracting 50 from the score obtained (50% indicating perfect execution) and recording it in absolute terms.
The final dynamic test involved weight shifting to 8 targets positioned in an ellipse, the perimeter of which corresponded to 75% of the LOS. The subjects are required to follow a ball to each target as it is highlighted, and remain at that target for 3 seconds before returning to the central target (neutral).
Targets are highlighted in random order, but each target is selected only once. The maximum allowable movement time to reach a target is 8 seconds. The average movement time and path sway (in terms of percentage of the LOS) is determined across targets. A score of 100% indicated that no path deviation had occurred, ie, perfect execution. (It should be noted that the processing of the data to produce the outcome measures described above is hard coded by NeuroCom.ª)
Main Outcome Measures:
Oxford Knee Score (OKS). The OKS is a self-completed patient based outcome score . It is a 12 item self-completed patient based outcome score. The questionnaire was developed from patient interview and validated against two generic health scales, the SF-36 and Health Assessment Questionnaire (HAQ) [44]. It was originally intended for use in large randomised controlled trials for patients undergoing total knee replacement, to assess levels of, and changes in, pain and function of the knee solely from the patient's viewpoint. Data collection can be via a postal questionnaire or by directed interview.
Visual Analog Scale (VAS).The severity of knee pain is evaluated by the VAS [45] after patients remain in a weight-bearing position (walking or standing) for 5 minutes in the parallel bars. The VAS instrument consisted of horizontal lines 10cm long, with anchor points of 0 (no pain) and 10 (maximum pain).
Four Square Step Test (FSST). FSST is a clinical measure of rapid stepping and obstacle avoidance . The equipment required for the FSST includes a stopwatch and 4 canes. The square is formed by using 4 canes resting flat on the floor. Canes are 90cm long, and the direction and type of handle used is not important. The subject stands in square number 1 facing square number 2. The aim is to step as fast as possible into each square in the following sequence. Square number 2, 3, 4, 1, 4, 3, 2, and 1. This sequence requires the subject to step forward, backward, and sideway to the right and left. The score is recorded as the time taken to complete the sequence. The stopwatch starts when the first foot contacts the floor in square 2 and finishes when the last foot comes back to touch the floor in square 1. The following instructions are given to the subject, "Try to complete the sequence as fast as possible without touching the sticks. Both feet must make contact with the floor in each square. If possible, face forward during the entire sequence." The sequence is then shown to the subject.
One practice trial is completed to ensure the subject knows the sequence. Two FSST are completed with the best time taken as the score. A trial is repeated if the subject fails to complete the sequence successfully, loses balance, or makes contact with a cane during the sequence. Subjects who were unable to face forward during the entire sequence and needed to turn before stepping into the next square were still given a score. All subjects wore their preferred shoes. The examiner stood in a position to see all steps taken by the subject, and an assistant provided the subject with close supervision. The entire test, including giving instructions and a practice trial, took less than 5 minutes to complete.
Time Up and Go test (TUG). Subjects are required to stand up from a chair with armrests, walk 3m, turn around, return to the chair, and sit down. The time taken to complete this task is measured in seconds with a stopwatch [47]. The TUG test showed a high degree of test-retest reliability in TUG scores in elderly subjects .
SF-36. This is a 36-item questionnaire which measures health functioning on eight scales, including a physical functioning scale, and is among the most widely used measures of quality of life in studies of patients and populations .Missing data and scoring procedures followed the SF-36 user guidelines .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| total knee replacement | Procedure or surgery | – |
Primary outcome
Balance Master Testing
Oxford Knee Score
Visual Analog Scale
Four Square Step Test
Time Up and Go test
1 secondary outcome
SF-36.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2008.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Isabella Schwartz, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing total knee replacement in people with Osteoarthritis and Total Knee Replacement, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2008. 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 Israel. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Isabella Schwartz, MD (972-25844474, isabellas@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Master Testing. The study lists 5 primary outcomes in all. 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 13 May 2008.