Knee Arthritis, OsteoarthritisNCT06096792
Muscle Recovery After Total Knee Arthroplasty
An observational study of Knee Arthritis, Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty (TKA) surgery is a common procedure performed to reduce pain, improve function, and enhance the quality of life in patients with end-stage knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Arthritis, Osteoarthritis
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2024to 11 Sep 2025
- How long will I take part?
- 2 Weeks
- 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 50 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent total knee arthroplasty at Hacettepe University faculty of medicine
Who may be able to join
- Age between 50 and 75 years.
- Have undergone unilateral total knee arthroplasty surgery due to osteoarthritis.
- Hemodynamically stable post-surgery.
- Willing to participate in the study.
Who cannot join
- Having any neurological or oncological issues.
- Having undergone revision surgery.
- Having a history of cardiovascular surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Samanpazari, 06100
About this study
Official title: Invastigation of the Relationship Between Early Quadriceps Arthrogenic Muscle Inhibition and Functional Recovery After Total Knee Arthroplasty
Total knee arthroplasty (TKA) surgery is a common procedure performed to reduce pain, improve function, and enhance the quality of life in patients with end-stage knee osteoarthritis. As with other knee-related injuries and surgeries, TKA surgery can lead to inhibition of the quadriceps muscle, resulting in a decrease in the muscle's capacity to generate maximum voluntary force. This issue can negatively affect post-injury rehabilitation and function. The long-term persistent neuromuscular muscle inhibition in the quadriceps, one of the most important anti-gravity muscles in our body, leads to muscle atrophy and strength loss, which is more determinant in the development of functional limitations compared to joint range of motion and knee pain.
There have been no studies found that assess the quadriceps muscle inhibition occurring during the hospitalization of patients undergoing total knee arthroplasty surgery and examine its impact on post-discharge functional status.
Read more
The aim of this study is to evaluate the severity of arthrogenic inhibition in the quadriceps muscle of patients following total knee arthroplasty surgery, which is widely practiced in our country and considered the gold standard for the treatment of end-stage knee osteoarthritis. Additionally, the study aims to investigate its impact on post-discharge functional recovery. The data obtained from this study will provide guidance in monitoring patients' early functional recovery post-surgery and in better planning post-surgical rehabilitation.
The study will include patients aged 50-75 who have undergone total knee arthroplasty surgery due to knee osteoarthritis. Demographic information such as age, height, weight, and body mass index will be recorded. Pain will be assessed using a visual analog scale, and edema will be measured during hospitalization, at the 2nd and 6th-week follow-up visits. In addition to all the evaluations, functional status will be assessed at the 2nd and 6th-week follow-up visits using the 5-repetition sit-to-stand test, 10-meter walking test, and 2-minute walking tests, as well as knee function evaluated through the WOMAC and KOS-ADLS questionnaires.
Read the detailed description
The study will include patients aged 50-75 who have undergone total knee arthroplasty surgery due to knee osteoarthritis. Demographic information such as age, height, weight, and body mass index will be recorded. Pain will be assessed using a visual analog scale, and edema will be measured during hospitalization, at the 2nd and 6th-week follow-up visits. In addition to all the evaluations, functional status will be assessed at the 2nd and 6th-week follow-up visits using the 5-repetition sit-to-stand test, 10-meter walking test, and 2-minute walking tests, as well as knee function evaluated through the WOMAC and KOS-ADLS questionnaires.
- Conditions
- Knee Arthritis, Osteoarthritis
- Keywords
- knee arthroplasty, Knee osteoarthritis, muscle inhibition
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle inhibition
Quadriceps maximum isometric muscle contraction will be evaluated by measuring the pneumatic pressure change with a pneumatic dynamometer.
Measured: postoperative day-1; postoperative day-2; postoperative day-3; postoperative 2th week and postoperative 6th week
Secondary outcomes (1)
Functional recovery
Five times sit to stand test
Measured: postoperative 2th week and postoperative 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start10 Oct 2024
- Primary completion20 Mar 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis, OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Bozgeyik, Hacettepe University
- Investigators
- Sibel Bozgeyik Bağdatlı, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096792
- Sponsor's protocol ID
- K-Bubble TKA
- Status last verified
- Mar 2026
- First submitted
- 18 Oct 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invastigation of the Relationship Between Early Quadriceps Arthrogenic Muscle Inhibition and Functional Recovery After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06096792
- Acronym / sponsor ID
- K-Bubble TKA
- Conditions
- Knee Arthritis, Osteoarthritis
- Keywords
- knee arthroplasty, Knee osteoarthritis, muscle inhibition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 24 Oct 2023 (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.
Total knee arthroplasty (TKA) surgery is a common procedure performed to reduce pain, improve function, and enhance the quality of life in patients with end-stage knee osteoarthritis. As with other knee-related injuries and surgeries, TKA surgery can lead to inhibition of the quadriceps muscle, resulting in a decrease in the muscle's capacity to generate maximum voluntary force. This issue can negatively affect post-injury rehabilitation and function. The long-term persistent neuromuscular muscle inhibition in the quadriceps, one of the most important anti-gravity muscles in our body, leads to muscle atrophy and strength loss, which is more determinant in the development of functional limitations compared to joint range of motion and knee pain.
There have been no studies found that assess the quadriceps muscle inhibition occurring during the hospitalization of patients undergoing total knee arthroplasty surgery and examine its impact on post-discharge functional status.
The aim of this study is to evaluate the severity of arthrogenic inhibition in the quadriceps muscle of patients following total knee arthroplasty surgery, which is widely practiced in our country and considered the gold standard for the treatment of end-stage knee osteoarthritis. Additionally, the study aims to investigate its impact on post-discharge functional recovery. The data obtained from this study will provide guidance in monitoring patients' early functional recovery post-surgery and in better planning post-surgical rehabilitation.
The study will include patients aged 50-75 who have undergone total knee arthroplasty surgery due to knee osteoarthritis. Demographic information such as age, height, weight, and body mass index will be recorded. Pain will be assessed using a visual analog scale, and edema will be measured during hospitalization, at the 2nd and 6th-week follow-up visits. In addition to all the evaluations, functional status will be assessed at the 2nd and 6th-week follow-up visits using the 5-repetition sit-to-stand test, 10-meter walking test, and 2-minute walking tests, as well as knee function evaluated through the WOMAC and KOS-ADLS questionnaires.
Detailed description
The study will include patients aged 50-75 who have undergone total knee arthroplasty surgery due to knee osteoarthritis. Demographic information such as age, height, weight, and body mass index will be recorded. Pain will be assessed using a visual analog scale, and edema will be measured during hospitalization, at the 2nd and 6th-week follow-up visits. In addition to all the evaluations, functional status will be assessed at the 2nd and 6th-week follow-up visits using the 5-repetition sit-to-stand test, 10-meter walking test, and 2-minute walking tests, as well as knee function evaluated through the WOMAC and KOS-ADLS questionnaires.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent total knee arthroplasty at Hacettepe University faculty of medicine
Key inclusion criteria (4 listed)
- Age between 50 and 75 years.
- Have undergone unilateral total knee arthroplasty surgery due to osteoarthritis.
- Hemodynamically stable post-surgery.
- Willing to participate in the study.
Key exclusion criteria (3 listed)
- Having any neurological or oncological issues.
- Having undergone revision surgery.
- Having a history of cardiovascular surgery.
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
muscle inhibition
Time frame: postoperative day-1; postoperative day-2; postoperative day-3; postoperative 2th week and postoperative 6th week
Quadriceps maximum isometric muscle contraction will be evaluated by measuring the pneumatic pressure change with a pneumatic dynamometer.
1 secondary outcome
Functional recovery
Time frame: postoperative 2th week and postoperative 6th week
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 16 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sibel Bozgeyik Bağdatlı, PhD principal investigator
Hacettepe University
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 Arthritis, Osteoarthritis, run by Hacettepe 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 4 inclusion and 3 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 16 Mar 2026. 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?
muscle inhibition (time frame: postoperative day-1; postoperative day-2; postoperative day-3; postoperative 2th week and postoperative 6th week). 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 16 Mar 2026.