Knee OsteoarthritisNCT01192334
Changes of the Single Limb Standing Balance After Total Knee Arthroplasty in Degenerative Osteoarthritis
An observational study of Knee Osteoarthritis, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
It was well known that total knee arthroplasty could improve the previously impaired proprioception in degenerative osteoarthritis. Most current researches have been focused on the change of the proprioception. However, the evaluation of the proprioception is based on the surrogated end. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Dec 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients to be scheduled to take a elective unilateral total knee arthroplasty
Who may be able to join
- Medial compartment degenerative knee osteoarthritis showing the varus deformity
Who cannot join
- History of surgery on the lower extremity except for arthroscopy or menisectomy
- Hip arthritis or, hip or back pain disturbing the standing
- History of participation in sport rehabilitation program within less than 6 months
- Presence of neurological or musculoskeletal disease disturbing the standing
- Patient to reject the participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study for Changes of the Single Limb Standing Balance After Total Knee Arthroplasty in Degenerative Osteoarthritis
It was well known that total knee arthroplasty could improve the previously impaired proprioception in degenerative osteoarthritis. Most current researches have been focused on the change of the proprioception. However, the evaluation of the proprioception is based on the surrogated end.
Double or single limb standing balance is considered functional scale. It is very important view for the prevention of slipping down injury in evidence-based approaches for knee osteoarthritis.
Read more
Unfortunately, few study have been performed for figuring proprioceptive change after surgery out.
Considering the similarity between the proprioception and the standing balance and reported positive result in proprioception after total knee arthroplasty, the investigators supposed that total knee arthroplasty might give an influence on the recovery of single limb standing balance.
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis arthroplasty postural balance
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
single limb standing balance
migration distance of center of pressure while single limb standing was recorded through balance performance monitoring
Measured: from issuing admision paper before the surgery up to 4 weeks, average time of this measurement is 2 weeks
single limb standing balance
migration distance of center of pressure while single limb standing was recorded through balance performance monitoring
Measured: from the surgery until the time in which patient shows the same pain score as the pre-operation pain score up to the post-operative 4 weeks, average time of this measurement is post-operative 2 weeks
single limb standing balance
migration distance of center of pressure while single limb standing was recorded through balance performance monitoring
Measured: post-operative 6 months
single limb standing balance
migration distance of center of pressure while single limb standing was recorded through balance performance monitoring
Measured: post-operative 12 months
Secondary outcomes (3)
balance index
balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine
Measured: from issuing admision paper before the surgery up to 4 weeks, average time of this measurement is 2 weeks
balance index
balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine
Measured: post-operative 6 months
balance index
balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine
Measured: post-operative 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionDec 2012
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Ho Hwang, Ulsan University Hospital
- Investigators
- Chang Ho Hwang, M.D., Study director, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192334
- Sponsor's protocol ID
- chhwang1
- Status last verified
- Dec 2013
- First submitted
- 30 Aug 2010
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for Changes of the Single Limb Standing Balance After Total Knee Arthroplasty in Degenerative Osteoarthritis
- ClinicalTrials.gov ID
- NCT01192334
- Acronym / sponsor ID
- chhwang1
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis arthroplasty postural balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Sep 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.
It was well known that total knee arthroplasty could improve the previously impaired proprioception in degenerative osteoarthritis. Most current researches have been focused on the change of the proprioception. However, the evaluation of the proprioception is based on the surrogated end.
Double or single limb standing balance is considered functional scale. It is very important view for the prevention of slipping down injury in evidence-based approaches for knee osteoarthritis.
Unfortunately, few study have been performed for figuring proprioceptive change after surgery out.
Considering the similarity between the proprioception and the standing balance and reported positive result in proprioception after total knee arthroplasty, the investigators supposed that total knee arthroplasty might give an influence on the recovery of single limb standing balance.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients to be scheduled to take a elective unilateral total knee arthroplasty
Key inclusion criteria (1 listed)
- Medial compartment degenerative knee osteoarthritis showing the varus deformity
Key exclusion criteria (5 listed)
- History of surgery on the lower extremity except for arthroscopy or menisectomy
- Hip arthritis or, hip or back pain disturbing the standing
- History of participation in sport rehabilitation program within less than 6 months
- Presence of neurological or musculoskeletal disease disturbing the standing
- Patient to reject the participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
single limb standing balance
Time frame: from issuing admision paper before the surgery up to 4 weeks, average time of this measurement is 2 weeks
migration distance of center of pressure while single limb standing was recorded through balance performance monitoring
single limb standing balance
Time frame: from the surgery until the time in which patient shows the same pain score as the pre-operation pain score up to the post-operative 4 weeks, average time of this measurement is post-operative 2 weeks
migration distance of center of pressure while single limb standing was recorded through balance performance monitoring
single limb standing balance
Time frame: post-operative 6 months
migration distance of center of pressure while single limb standing was recorded through balance performance monitoring
single limb standing balance
Time frame: post-operative 12 months
migration distance of center of pressure while single limb standing was recorded through balance performance monitoring
3 secondary outcomes
balance index
Time frame: from issuing admision paper before the surgery up to 4 weeks, average time of this measurement is 2 weeks
balance index
Time frame: post-operative 6 months
balance index
Time frame: post-operative 12 months
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 24 Dec 2013.
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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.
Chang Ho Hwang, M.D. study director
Ulsan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Ulsan University Hospital at 1 site in South Korea.
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 1 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 24 Dec 2013. 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 South Korea. 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?
single limb standing balance (time frame: from issuing admision paper before the surgery up to 4 weeks, average time of this measurement is 2 weeks). The study lists 4 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 24 Dec 2013.