Knee ArthropathyNCT04796519
Comparison of Balance and Fall Risk in Unilateral and Bilateral Total Knee Arthroplasty
A study testing Total knee arthroplasty in people with Knee Arthropathy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Static or dynamic postural control cannot be fully restored in patients with Total Knee Arthroplasty (TKA). Moreover, deficits in balance and postural control may still be present in both extremity after TKA. Read more about this study
- Who is it for?
- Ages 46 to 82 years
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2019to 10 Oct 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 46 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 55 to 85 years, patients with bilateral osteoarthritis, Kellgren-Lawrence grade 3-4, patients capable of understanding verbal and written instructions.
Who cannot join
- revision TKA surgery, American Society of Anesthesiologists score >3, neurologic compromise, psychiatric problems, regular hypnotic and/or anxiolytic medication usage, dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Balance and Fall Risk in Patients With Unilateral and Bilateral Total Knee Arthroplasty
Static or dynamic postural control cannot be fully restored in patients with Total Knee Arthroplasty (TKA). Moreover, deficits in balance and postural control may still be present in both extremity after TKA. However, the contralateral knee OA grade, asymmetrical gait pattern, and postural sways still remain a risk factor for balance deficits and falls. Based on this rationale, the aim of this study is to evaluate the balance and fall risk before and after TKA in patients who suffered from bilateral knee osteoarthritis and to clarify the balance and fall risk difference between unilateral and bilateral TKA patients.
Read the detailed description
Falls are one of the leading causes of increased morbidity and mortality in the elderly population and are substantial contributor to increase healthcare cost burden. Pain, strength deficits, knee joint deformities, balance and proprioceptive impairments associated with severe knee OA, contribute to an increased risk of falling among elderly, and more than 50% of this population experience a fall each year. Static or dynamic postural control cannot be fully restored in patients with Total Knee Arthroplasty (TKA). Moreover, deficits in balance and postural control may still be present in both extremity after TKA. Increased weight-bearing on the operative side after TKA and reduced weight-bearing weight in the contralateral osteoarthritic knee can reduce pain and improve balance-related functions. However, the contralateral knee OA grade, asymmetrical gait pattern, and postural sways still remain a risk factor for balance deficits and falls. Based on this rationale, the aim of this study is to evaluate the balance and fall risk before and after TKA in patients who suffered from bilateral knee osteoarthritis and to clarify the balance and fall risk difference between unilateral and bilateral TKA patients.
- Conditions
- Knee Arthropathy
- Being tested
- Total knee arthroplasty
- Keywords
- fall risk, balance, total knee arthroplasty, function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Unilateral TKA | Experimental | Unilateral total knee arthroplasty group (UTKA) consisted of patients who did not undergo a second TKA within 3 months of the first TKA Receives: Procedure: Total knee arthroplasty |
| Bilateral TKA | Experimental | bilateral total knee arthroplasty group (BTKA) were those who had a second TKA within 12 months after initial TKA Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall risk evaluation
Fall risk was evaluated using the Biodex Balance System SD (Biodex Medical Systems Inc., Shirley, NY, USA). The Fall Risk test was conducted to identify potential fall candidates. Test results are compared with age-related normative data.
Measured: 3 months
Balance evaluation
Balance (Postural Stability and Sensory Integration) was evaluated using the Biodex Balance System SD (Biodex Medical Systems Inc., Shirley, NY, USA). Postural Stability Test was applied to determine a patient's ability to maintain the centre of balance. Sensory Integration Test aims to evaluate the individual's ability to both integrate various senses to maintain balance and to compensate when one of these senses is missing. This test included four conditions: Eyes Open-Firm Surface, Eyes Closed-Firm Surface, Eyes Open-Foam Surface, and Eyes Closed-Foam Surface. Each assessment lasted 30 seconds, with 10 seconds of rest in between assessments.
Measured: 3 months
Secondary outcomes (5)
Western Ontario and McMaster Universities Osteoarthritis Index score
It is a patient reported questionnaire that evaluates pain, stiffness, and physical function in patients with hip and knee OA. The index consists of 24 questions and is completed in less than 5 minutes. The scores of the questions range from 0 (none) to 4 (very severe) and the results are evaluated over 100 points (minimum score:0 and the maximum score:100). Higher scores indicates worst knee functions.
Measured: 3 months
Quality of life measure
Patients' quality of life were evaluated with Short Form-12 for seconder outcome. Higher scores indicates better quality of life.
Measured: 3 months
Sit-to-stand test
The patient was seated in the middle of a chair with a height of 44 cm, with his back straight, arms crossed in front of his chest, and feet on the ground. The patient was asked to get up from the chair and sit down as much as the patient could for 30 seconds. The exact number of starts made formed the patient's score. Higher scores indicates better overall strength.
Measured: 3 months
9-step stair climbing test
The patient was asked to climb and descend the 9-step 16-20 centimeter ladder as quickly but safely as possible. The patient was allowed to use a handrail or a walking aid, and the method used was recorded. The test was started with the start command and the time stopped when the patient returned to the starting place. The patient was allowed to stop and rest when requested, but the duration was continued. The total time was recorded as a score. Lower scores indicates better knee functions.
Measured: 3 months
40 m fast-paced walk test
Patients were asked to walk along the 10-meter track without running but as fast as possible, turn around the cone at the finish, and complete the 40-meter total distance. After the patient passed the baseline in the last stage, the time was stopped and the total time was recorded. Lower scores indicates better walking capacity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start10 Apr 2019
- Primary completion1 Jul 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erman tütüncüler, Pamukkale University
- Investigators
- Erman Tütüncüler, Dr., Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796519
- Sponsor's protocol ID
- Balance, Fall risk after TKA
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zora H, Gungor HR, Bayrak G, Savkin R, Buker N. Does mini-midvastus approach have an advantageous effect on rapid recovery protocols over medial parapatellar approach in total knee arthroplasty? Jt Dis Relat Surg. 2020;31(3):571-581. doi: 10.5606/ehc.2020.76387.
PubMed 32962591Vala CH, Karrholm J, Kanis JA, Johansson H, Sten S, Sundh V, Karlsson M, Lorentzon M, Mellstrom D. Risk for hip fracture before and after total knee replacement in Sweden. Osteoporos Int. 2020 May;31(5):887-895. doi: 10.1007/s00198-019-05241-x. Epub 2019 Dec 12.
PubMed 31832694Bakirhan S, Angin S, Karatosun V, Unver B, Gunal I. Physical performance parameters during standing up in patients with unilateral and bilateral total knee arthroplasty. Acta Orthop Traumatol Turc. 2012;46(5):367-72. doi: 10.3944/aott.2012.2684.
PubMed 23268822
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Balance and Fall Risk in Patients With Unilateral and Bilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04796519
- Acronym / sponsor ID
- Balance, Fall risk after TKA
- Conditions
- Knee Arthropathy
- Keywords
- fall risk, balance, total knee arthroplasty, function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 15 Mar 2021 (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.
Static or dynamic postural control cannot be fully restored in patients with Total Knee Arthroplasty (TKA). Moreover, deficits in balance and postural control may still be present in both extremity after TKA. However, the contralateral knee OA grade, asymmetrical gait pattern, and postural sways still remain a risk factor for balance deficits and falls. Based on this rationale, the aim of this study is to evaluate the balance and fall risk before and after TKA in patients who suffered from bilateral knee osteoarthritis and to clarify the balance and fall risk difference between unilateral and bilateral TKA patients.
Detailed description
Falls are one of the leading causes of increased morbidity and mortality in the elderly population and are substantial contributor to increase healthcare cost burden. Pain, strength deficits, knee joint deformities, balance and proprioceptive impairments associated with severe knee OA, contribute to an increased risk of falling among elderly, and more than 50% of this population experience a fall each year. Static or dynamic postural control cannot be fully restored in patients with Total Knee Arthroplasty (TKA). Moreover, deficits in balance and postural control may still be present in both extremity after TKA. Increased weight-bearing on the operative side after TKA and reduced weight-bearing weight in the contralateral osteoarthritic knee can reduce pain and improve balance-related functions. However, the contralateral knee OA grade, asymmetrical gait pattern, and postural sways still remain a risk factor for balance deficits and falls. Based on this rationale, the aim of this study is to evaluate the balance and fall risk before and after TKA in patients who suffered from bilateral knee osteoarthritis and to clarify the balance and fall risk difference between unilateral and bilateral TKA patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral TKA | Experimental | Procedure: Total knee arthroplastyUnilateral total knee arthroplasty group (UTKA) consisted of patients who did not undergo a second TKA within 3 months of the first TKA |
| Bilateral TKA | Experimental | Procedure: Total knee arthroplastybilateral total knee arthroplasty group (BTKA) were those who had a second TKA within 12 months after initial TKA |
Who may qualify
- Ages
- 46 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age between 55 to 85 years, patients with bilateral osteoarthritis, Kellgren-Lawrence grade 3-4, patients capable of understanding verbal and written instructions.
Key exclusion criteria (1 listed)
- revision TKA surgery, American Society of Anesthesiologists score >3, neurologic compromise, psychiatric problems, regular hypnotic and/or anxiolytic medication usage, dementia.
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 arthroplastySurgical procedure | Procedure or surgery | Bilateral TKA, Unilateral TKA |
Primary outcome
Fall risk evaluation
Time frame: 3 months
Fall risk was evaluated using the Biodex Balance System SD (Biodex Medical Systems Inc., Shirley, NY, USA). The Fall Risk test was conducted to identify potential fall candidates. Test results are compared with age-related normative data.
Balance evaluation
Time frame: 3 months
Balance (Postural Stability and Sensory Integration) was evaluated using the Biodex Balance System SD (Biodex Medical Systems Inc., Shirley, NY, USA). Postural Stability Test was applied to determine a patient's ability to maintain the centre of balance. Sensory Integration Test aims to evaluate the individual's ability to both integrate various senses to maintain balance and to compensate when one of these senses is missing. This test included four conditions: Eyes Open-Firm Surface, Eyes Closed-Firm Surface, Eyes Open-Foam Surface, and Eyes Closed-Foam Surface. Each assessment lasted 30 seconds, with 10 seconds of rest in between assessments.
5 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index score
Time frame: 3 months
Quality of life measure
Time frame: 3 months
Sit-to-stand test
Time frame: 3 months
9-step stair climbing test
Time frame: 3 months
40 m fast-paced walk test
Time frame: 3 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 15 Mar 2021.
- Results publication: PubMed 32962591Zora H, Gungor HR, Bayrak G, Savkin R, Buker N. Does mini-midvastus approach have an advantageous effect on rapid recovery protocols over medial parapatellar approach in total knee arthroplasty? Jt Dis Relat Surg. 2020;31(3):571-581. doi: 10.5606/ehc.2020.76387.
- Results publication: PubMed 31832694Vala CH, Karrholm J, Kanis JA, Johansson H, Sten S, Sundh V, Karlsson M, Lorentzon M, Mellstrom D. Risk for hip fracture before and after total knee replacement in Sweden. Osteoporos Int. 2020 May;31(5):887-895. doi: 10.1007/s00198-019-05241-x. Epub 2019 Dec 12.
- Results publication: PubMed 23268822Bakirhan S, Angin S, Karatosun V, Unver B, Gunal I. Physical performance parameters during standing up in patients with unilateral and bilateral total knee arthroplasty. Acta Orthop Traumatol Turc. 2012;46(5):367-72. doi: 10.3944/aott.2012.2684.
- Individual participant dataSharing planned: No
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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.
Erman Tütüncüler, Dr. principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty in people with Knee Arthropathy, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 1 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 15 Mar 2021. 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 Turkey (Türkiye). 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?
Fall risk evaluation (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04796519, which also lists 3 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 15 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.