Total Knee ArthroplastyNCT06977529
Fall Prevention in Total Knee Replacement Patients
A study testing Algorithm; Algorithm-based maintenance created by researchers:such as falls training, early mobilization in people with Total Knee Arthroplasty, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Falls, one of the patient safety goals, lead to injury and death if not prevented. This study was conducted to determine the effect of algorithm-guided care on falling, fear of movement, fear of falling and postoperative recovery index for patients with total knee replacement surgery at high risk of falling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Algorithm; Algorithm-based maintenance created by researchers:such as falls training, early mobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2024to 20 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a unilateral total knee replacement surgery for the first time,
- Not having a psychiatric illness diagnosis,
- Being able to speak and understand Turkish,
- Being willing to participate in the research.
Who cannot join
- Patients who will undergo emergency surgery,
- Have hearing and speech problems,
- Have visual impairment,
- Have conditions that may affect cognitive functions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep Universty
Gaziantep, ŞAHİNBEY, 27900
About this study
Official title: The Effect Of Algorithm-Guided Care Provided To Total Knee Prosthesis Patients On Fall And Recovery: Randomized Controlled Trial
Falls, one of the patient safety goals, lead to injury and death if not prevented. This study was conducted to determine the effect of algorithm-guided care on falling, fear of movement, fear of falling and postoperative recovery index for patients with total knee replacement surgery at high risk of falling. The research was conducted as a randomized, controlled and experimental study in the orthopedic clinics of a city hospital and a state hospital between 20.01.2024 and 04.06.2024. The sample of the study consisted of 56 patients who would undergo total knee replacement surgery with a high risk of falling. The patients were divided into two groups: experimental (n=28) and control (n=28) groups. "Patient Questionnaire", "Postoperative Recovery Index (ASII)", "Tampa Kinesiophobia Scale (TKÖ)", "International Fall Effectiveness Scale (UDES)" were applied to all patients participating in the study. The "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Algorithm; Algorithm-based maintenance created by researchers:such as falls training, early mobilization
- Keywords
- ALGORİTHM, FALL, PATİENT SAFETY, TOTAL KNEE ARTHROPLASTY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm; Algorithm-based maintenance created by researchers:such as falls training, early mobilizationBehavioural
The "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients.
| Study group | Role | What they receive |
|---|---|---|
| EXPERİMENTAL | Experimental | The "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients. Receives: Behavioral: Algorithm; Algorithm-based maintenance created by researchers:such as falls training, early mobilization |
| control | No intervention | No intervention was made by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FALL
Patients' fall status will be recorded by asking questions in the "Patient Questionnaire Form".
Measured: Perioperative period , Within 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start20 Jan 2024
- Primary completion4 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel ARSLAN, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977529
- Sponsor's protocol ID
- Gaziantep Unıv.
- Status last verified
- May 2025
- First submitted
- 24 Mar 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Algorithm-Guided Care Provided To Total Knee Prosthesis Patients On Fall And Recovery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06977529
- Acronym / sponsor ID
- Gaziantep Unıv.
- Conditions
- Total Knee Arthroplasty
- Keywords
- ALGORİTHM, FALL, PATİENT SAFETY, TOTAL KNEE ARTHROPLASTY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 18 May 2025 (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.
Falls, one of the patient safety goals, lead to injury and death if not prevented. This study was conducted to determine the effect of algorithm-guided care on falling, fear of movement, fear of falling and postoperative recovery index for patients with total knee replacement surgery at high risk of falling. The research was conducted as a randomized, controlled and experimental study in the orthopedic clinics of a city hospital and a state hospital between 20.01.2024 and 04.06.2024. The sample of the study consisted of 56 patients who would undergo total knee replacement surgery with a high risk of falling. The patients were divided into two groups: experimental (n=28) and control (n=28) groups. "Patient Questionnaire", "Postoperative Recovery Index (ASII)", "Tampa Kinesiophobia Scale (TKÖ)", "International Fall Effectiveness Scale (UDES)" were applied to all patients participating in the study. The "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERİMENTAL | Experimental | Behavioral: Algorithm; Algorithm-based maintenance created by researchers:such as falls training, early mobilizationThe "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients. |
| control | No intervention | –No intervention was made by the researcher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having a unilateral total knee replacement surgery for the first time,
- Not having a psychiatric illness diagnosis,
- Being able to speak and understand Turkish,
- Being willing to participate in the research.
Key exclusion criteria (4 listed)
- Patients who will undergo emergency surgery,
- Have hearing and speech problems,
- Have visual impairment,
- Have conditions that may affect cognitive functions
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 |
|---|---|---|
| Algorithm; Algorithm-based maintenance created by researchers:such as falls training, early mobilizationThe "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients. | Behavioural | EXPERİMENTAL |
Primary outcome
FALL
Time frame: Perioperative period , Within 30 days after surgery.
Patients' fall status will be recorded by asking questions in the "Patient Questionnaire Form".
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 18 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm; Algorithm-based maintenance created by researchers:such as falls training, early mobilization in people with Total Knee Arthroplasty, run by University of Gaziantep 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 4 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: finished, as of the sponsor's last update on 18 May 2025. 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 (time frame: Perioperative period , Within 30 days after surgery.). 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 18 May 2025.