Knee OsteoarthritisNCT07882316
Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty
An observational study of Knee Osteoarthritis and Multimorbidity, run by Balikesir Ataturk City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study aims to investigate the association between preoperative multimorbidity burden and functional recovery after primary total knee arthroplasty (TKA) in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Multimorbidity
- How many people
- 230 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2026to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: The study population will consist of adult patients aged 18 years or older with primary knee osteoarthritis who are scheduled to undergo elective unilateral primary total knee arthroplasty at the Department of Orthopedics and Traumatology, Balikesir Ataturk City Hospital, Türkiye. Eligible patients will be consecutively recruited during the study enrollment period. All participants will receive standard surgical treatment and postoperative rehabilitation according to routine institutional practice. Participants will be followed prospectively, with clinical and patient-reported outcome assessments performed preoperatively and at 6 and 12 months after surgery.
Who may be able to join
- Adults aged 18 years or older.
- Scheduled for elective unilateral primary total knee arthroplasty due to primary knee osteoarthritis.
- Sufficient cognitive and communication abilities to understand and complete the study questionnaires.
- Provision of written informed consent for study participation.
Who cannot join
- Patients scheduled for revision total knee arthroplasty.
- Patients scheduled for simultaneous bilateral total knee arthroplasty.
- Arthroplasty indicated for inflammatory arthritis, tumor, infection, or post-traumatic conditions.
- Severe cognitive impairment, advanced dementia, or communication difficulties preventing valid completion of the study questionnaires.
- Significant logistical or legal circumstances preventing completion of the planned follow-up assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Güneş Sarikaya
Balıkesir, +90(543)673-3113
Güneş SARIKAYA, 05436733113, gunessarikaya05@hotmail.com
About this study
Official title: Effect of Preoperative Multimorbidity Burden on the Trajectory of Functional Recovery After Primary Total Knee Arthroplasty: A Single-Center Prospective Observational Cohort Study
This prospective observational cohort study aims to investigate the association between preoperative multimorbidity burden and functional recovery after primary total knee arthroplasty (TKA) in patients with knee osteoarthritis.
Approximately 230 adult patients undergoing elective unilateral primary TKA will be enrolled at a single hospital in Türkiye. Preoperative multimorbidity burden will be assessed using the Functional Comorbidity Index (FCI), which measures the presence of medical conditions that may affect physical function.
Read more
Patients will be evaluated before surgery and at 6 and 12 months after surgery. Functional outcomes and pain will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Oxford Knee Score (OKS). Anxiety and depressive symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS).
The primary objective is to determine whether higher preoperative multimorbidity burden is associated with poorer physical function at 12 months after TKA. The study will also examine changes in functional recovery over time and other clinical outcomes.
All surgical procedures, postoperative care, and rehabilitation will follow routine clinical practice. No additional treatment or experimental intervention will be assigned as part of this study.
Read the detailed description
Total knee arthroplasty (TKA) is an effective surgical treatment for advanced knee osteoarthritis, providing substantial improvements in pain and physical function. However, the extent and trajectory of postoperative recovery vary considerably among patients. Preoperative multimorbidity may influence recovery, although previous studies have reported inconsistent findings regarding its association with postoperative functional improvement.
This single-center, prospective observational cohort study will evaluate the relationship between preoperative multimorbidity burden and functional recovery after elective unilateral primary TKA.
A target sample of 230 adult patients undergoing primary TKA for knee osteoarthritis will be consecutively enrolled. The sample size accounts for potential loss to follow-up, with a target of at least 166 patients completing the 12-month assessment.
Preoperative multimorbidity burden will be evaluated using the Functional Comorbidity Index (FCI), an 18-item index developed to assess comorbidity burden in relation to physical function. Comorbid conditions will be identified through patient interviews and verified using medical records and medication histories.
Patient-reported outcomes will be collected preoperatively and at 6 and 12 months postoperatively. The WOMAC will assess pain, stiffness, and physical function, while the Oxford Knee Score (OKS) will provide an additional assessment of knee-related pain and function. The Hospital Anxiety and Depression Scale (HADS) will assess psychological symptom burden.
The primary outcome will be the WOMAC physical function subscale score at 12 months after surgery. Secondary assessments will examine longitudinal changes in WOMAC scores, OKS, HADS, knee range of motion, patient satisfaction, postoperative complications, hospital readmissions, manipulation under anesthesia, and revision surgery.
All patients will receive posterior-stabilized primary knee prostheses and follow the institution's standard postoperative rehabilitation protocol. Surgical procedures will be performed by orthopedic surgeons according to routine clinical practice. No additional treatment or alteration to standard care will be introduced for research purposes.
The primary analysis will assess the association between baseline FCI score and 12-month WOMAC physical function score using multivariable linear regression, adjusting for prespecified clinical
- Conditions
- Knee Osteoarthritis, Multimorbidity
- Keywords
- Total Knee Arthroplasty, Functional Comorbidity Index, Functional Recovery, Patient-Reported Outcome Measures
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Physical Function Subscale Score at 12 Months
Physical function will be assessed using the 17-item physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), using the validated Turkish Likert version. Each item is scored from 0 to 4, yielding a total subscale score ranging from 0 to 68. Higher scores indicate greater functional limitations.
Measured: 12 months after surgery
Secondary outcomes (1)
Change in WOMAC Physical Function Score From Baseline
Change in the WOMAC physical function subscale score from baseline to 6 and 12 months after surgery. The subscale contains 17 items scored from 0 to 4, with a total score ranging from 0 to 68. Higher scores indicate greater functional limitations. Change will be calculated as the follow-up score minus the baseline score; negative values indicate improvement.
Measured: Baseline (preoperative), 6 months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start26 Jun 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balikesir Ataturk City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, güneş sarıkaya, Balikesir Ataturk City Hospital
- Investigators
- Güneş SARIKAYA, Principal investigator, Balikesir Ataturk City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882316
- Sponsor's protocol ID
- TKA-FCI-2026-01
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Multimorbidity Burden on the Trajectory of Functional Recovery After Primary Total Knee Arthroplasty: A Single-Center Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07882316
- Acronym / sponsor ID
- TKA-FCI-2026-01
- Conditions
- Knee Osteoarthritis, Multimorbidity
- Keywords
- Total Knee Arthroplasty, Functional Comorbidity Index, Functional Recovery, Patient-Reported Outcome Measures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Balikesir Ataturk City HospitalOther government
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 20 Oct 2026 (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.
This prospective observational cohort study aims to investigate the association between preoperative multimorbidity burden and functional recovery after primary total knee arthroplasty (TKA) in patients with knee osteoarthritis.
Approximately 230 adult patients undergoing elective unilateral primary TKA will be enrolled at a single hospital in Türkiye. Preoperative multimorbidity burden will be assessed using the Functional Comorbidity Index (FCI), which measures the presence of medical conditions that may affect physical function.
Patients will be evaluated before surgery and at 6 and 12 months after surgery. Functional outcomes and pain will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Oxford Knee Score (OKS). Anxiety and depressive symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS).
The primary objective is to determine whether higher preoperative multimorbidity burden is associated with poorer physical function at 12 months after TKA. The study will also examine changes in functional recovery over time and other clinical outcomes.
All surgical procedures, postoperative care, and rehabilitation will follow routine clinical practice. No additional treatment or experimental intervention will be assigned as part of this study.
Detailed description
Total knee arthroplasty (TKA) is an effective surgical treatment for advanced knee osteoarthritis, providing substantial improvements in pain and physical function. However, the extent and trajectory of postoperative recovery vary considerably among patients. Preoperative multimorbidity may influence recovery, although previous studies have reported inconsistent findings regarding its association with postoperative functional improvement.
This single-center, prospective observational cohort study will evaluate the relationship between preoperative multimorbidity burden and functional recovery after elective unilateral primary TKA.
A target sample of 230 adult patients undergoing primary TKA for knee osteoarthritis will be consecutively enrolled. The sample size accounts for potential loss to follow-up, with a target of at least 166 patients completing the 12-month assessment.
Preoperative multimorbidity burden will be evaluated using the Functional Comorbidity Index (FCI), an 18-item index developed to assess comorbidity burden in relation to physical function. Comorbid conditions will be identified through patient interviews and verified using medical records and medication histories.
Patient-reported outcomes will be collected preoperatively and at 6 and 12 months postoperatively. The WOMAC will assess pain, stiffness, and physical function, while the Oxford Knee Score (OKS) will provide an additional assessment of knee-related pain and function. The Hospital Anxiety and Depression Scale (HADS) will assess psychological symptom burden.
The primary outcome will be the WOMAC physical function subscale score at 12 months after surgery. Secondary assessments will examine longitudinal changes in WOMAC scores, OKS, HADS, knee range of motion, patient satisfaction, postoperative complications, hospital readmissions, manipulation under anesthesia, and revision surgery.
All patients will receive posterior-stabilized primary knee prostheses and follow the institution's standard postoperative rehabilitation protocol. Surgical procedures will be performed by orthopedic surgeons according to routine clinical practice. No additional treatment or alteration to standard care will be introduced for research purposes.
The primary analysis will assess the association between baseline FCI score and 12-month WOMAC physical function score using multivariable linear regression, adjusting for prespecified clinical
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 18 years or older with primary knee osteoarthritis who are scheduled to undergo elective unilateral primary total knee arthroplasty at the Department of Orthopedics and Traumatology, Balikesir Ataturk City Hospital, Türkiye. Eligible patients will be consecutively recruited during the study enrollment period. All participants will receive standard surgical treatment and postoperative rehabilitation according to routine institutional practice. Participants will be followed prospectively, with clinical and patient-reported outcome assessments performed preoperatively and at 6 and 12 months after surgery.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Scheduled for elective unilateral primary total knee arthroplasty due to primary knee osteoarthritis.
- Sufficient cognitive and communication abilities to understand and complete the study questionnaires.
- Provision of written informed consent for study participation.
Key exclusion criteria (5 listed)
- Patients scheduled for revision total knee arthroplasty.
- Patients scheduled for simultaneous bilateral total knee arthroplasty.
- Arthroplasty indicated for inflammatory arthritis, tumor, infection, or post-traumatic conditions.
- Severe cognitive impairment, advanced dementia, or communication difficulties preventing valid completion of the study questionnaires.
- Significant logistical or legal circumstances preventing completion of the planned follow-up assessments.
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
WOMAC Physical Function Subscale Score at 12 Months
Time frame: 12 months after surgery
Physical function will be assessed using the 17-item physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), using the validated Turkish Likert version. Each item is scored from 0 to 4, yielding a total subscale score ranging from 0 to 68. Higher scores indicate greater functional limitations.
1 secondary outcome
Change in WOMAC Physical Function Score From Baseline
Time frame: Baseline (preoperative), 6 months and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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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.
Güneş SARIKAYA principal investigator
Balikesir Ataturk City 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 and Multimorbidity, run by Balikesir Ataturk City Hospital 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 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: looking for participants now, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Güneş SARIKAYA (05436733113, gunessarikaya05@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Physical Function Subscale Score at 12 Months (time frame: 12 months 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 4 Nov 2026.