Orthopedic DisorderNCT04481711
Total Knee Arthroplasty and Clinical Findings
A study testing Total Knee Arthroplasty in people with Orthopedic Disorder and Arthropathy of Knee, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Knee osteoarthritis is a common disease that causes pain and loss of function. Total Knee Arthroplasty (TKA) is a frequently used surgical method in the treatment of severe knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Orthopedic Disorder, Arthropathy of Knee, Pain, Joint
- 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
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Nov 2018to 8 May 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with grade 4 degeneration levels who had surgical indications between the ages of 45-75 were placed in the study group.
- Patients without surgical indication, lower than 4 OA severity included in the control group
Who cannot join
- Patients with surgical history of the ipsilateral side, neuropathic pain, loss of sensation, systemic, chronic and infectious disease were excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical Üniversitesi
Trabzon, Türkiye, 61080
About this study
Official title: Investigation of the Effect of Total Knee Arthroplasty on Proinflammatory Cytokine Level, Pain Severity, Functional Status, Joint Position Sense and Radiographic Findings
Knee osteoarthritis is a common disease that causes pain and loss of function. Total Knee Arthroplasty (TKA) is a frequently used surgical method in the treatment of severe knee osteoarthritis. The aim of this study was to investigate the effect of TKA on IL-6, TNF-α and IL-1β cytokine levels, pain intensity at rest and walking, knee joint valgity angle,malaligment, functional status and knee joint position sense.
Read the detailed description
Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the TKA group (study group) and 22 patients (female/male:13/9) with <grade 4 osteoarthritis were included in the control group. Systemic venous blood samples of the patients were taken to evaluate the cytokine level (IL-6, TNF-α, IL-1). The Visual Analogue Scale was used to assess pain intensity, and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score was used to evaluate the functional status. Valgity and malaligment measurements were calculated using antero-posterior X ray Digital goniometer was used to evaluate the knee joint position sense (at 35, 55 and 70 degrees knee flexion angles). Measurements were taken once from patients in the control group, and twice in pre-op and post-op sixth weeks from study group.
- Being tested
- Total Knee Arthroplasty
- Medical subject headings
- Musculoskeletal Diseases, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Osteoarthritis (OA) is one of the most common chronic peripheral joint diseases increasing among the aging population.Pathogenesis is not fully known.One of the most common risk factors and causes are loss of pain and function. Knee joint osteoarthritis adversly affects the person's life quality. Total Knee Arthroplasty (TKA) is a surgical approach to restore tibiofemoral joint alignment, especially in the severe level of knee OA.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the study group. These patients underwent total knee arthroplasty Receives: Procedure: Total Knee Arthroplasty |
| Control group | No intervention | Twenty-two patients (female/male:13/9) with <grade 4 osteoarthritis were included in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proinflammatory cytokine level
Systemic venous blood samples were taken. IL-6, TNF-α and IL-1β cytokine levels were examined.
Measured: 30 minutes
Pain severity
The pain intensity were evaluated by the Visuel Analog Scale.
Measured: 15 minutes
Functional status
The Western Ontario and McMaster Universities Arthritis Index was used for functional status.
Measured: 30 minutes
Joint position sense
Electro-goniometer was used for proprioception evaluation
Measured: 30 minutes
Valgity angle and amount of malaligment
In this evaluation, the valgity angle and the malalingement amount were calculated on the knee antero-posterior direct X-ray imageby an experienced orthopedist
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start8 Nov 2018
- Primary completion8 Feb 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat EMİRZEOĞLU, Karadeniz Technical University
- Investigators
- Murat Emirzeoğlu, Study chair, Karadeniz Technical UniversityArzu Erden, Study director, Karadeniz Technical UniversityKübra Canlı, Study chair, Hacettepe UniversitySerap Özer Yaman, Study chair, Karadeniz Technical Universityİbrahim Pekşen, Study chair, Karadeniz Technical UniversityOsman Aynacı, Study chair, Karadeniz Technical UniversitySüleyman Caner Karahan, Study chair, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481711
- Sponsor's protocol ID
- 2018-91
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- 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 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Total Knee Arthroplasty on Proinflammatory Cytokine Level, Pain Severity, Functional Status, Joint Position Sense and Radiographic Findings
- ClinicalTrials.gov ID
- NCT04481711
- Acronym / sponsor ID
- 2018-91
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 8 Feb 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 22 Jul 2020 (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.
Knee osteoarthritis is a common disease that causes pain and loss of function. Total Knee Arthroplasty (TKA) is a frequently used surgical method in the treatment of severe knee osteoarthritis. The aim of this study was to investigate the effect of TKA on IL-6, TNF-α and IL-1β cytokine levels, pain intensity at rest and walking, knee joint valgity angle,malaligment, functional status and knee joint position sense.
Detailed description
Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the TKA group (study group) and 22 patients (female/male:13/9) with <grade 4 osteoarthritis were included in the control group. Systemic venous blood samples of the patients were taken to evaluate the cytokine level (IL-6, TNF-α, IL-1). The Visual Analogue Scale was used to assess pain intensity, and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score was used to evaluate the functional status. Valgity and malaligment measurements were calculated using antero-posterior X ray Digital goniometer was used to evaluate the knee joint position sense (at 35, 55 and 70 degrees knee flexion angles). Measurements were taken once from patients in the control group, and twice in pre-op and post-op sixth weeks from study group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Total Knee ArthroplastyTwenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the study group. These patients underwent total knee arthroplasty |
| Control group | No intervention | –Twenty-two patients (female/male:13/9) with <grade 4 osteoarthritis were included in the control group. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with grade 4 degeneration levels who had surgical indications between the ages of 45-75 were placed in the study group.
- Patients without surgical indication, lower than 4 OA severity included in the control group
Key exclusion criteria (1 listed)
- Patients with surgical history of the ipsilateral side, neuropathic pain, loss of sensation, systemic, chronic and infectious disease were excluded from the study
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 ArthroplastyOsteoarthritis (OA) is one of the most common chronic peripheral joint diseases increasing among the aging population.Pathogenesis is not fully known.One of the most common risk factors and causes are loss of pain and function. Knee joint osteoarthritis adversly affects the person's life quality. Total Knee Arthroplasty (TKA) is a surgical approach to restore tibiofemoral joint alignment, especially in the severe level of knee OA. | Procedure or surgery | Study group |
Primary outcome
Proinflammatory cytokine level
Time frame: 30 minutes
Systemic venous blood samples were taken. IL-6, TNF-α and IL-1β cytokine levels were examined.
Pain severity
Time frame: 15 minutes
The pain intensity were evaluated by the Visuel Analog Scale.
Functional status
Time frame: 30 minutes
The Western Ontario and McMaster Universities Arthritis Index was used for functional status.
Joint position sense
Time frame: 30 minutes
Electro-goniometer was used for proprioception evaluation
Valgity angle and amount of malaligment
Time frame: 30 minutes
In this evaluation, the valgity angle and the malalingement amount were calculated on the knee antero-posterior direct X-ray imageby an experienced orthopedist
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 Jul 2020.
- 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.
Murat Emirzeoğlu study chair
Karadeniz Technical University
Arzu Erden study director
Karadeniz Technical University
Kübra Canlı study chair
Hacettepe 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 Orthopedic Disorder and Arthropathy of Knee, run by Karadeniz Technical 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 2 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 24 Jul 2020. 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?
Proinflammatory cytokine level (time frame: 30 minutes). 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 24 Jul 2020.