NCT07882316 Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty
| NCT ID | NCT07882316 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Balikesir Ataturk City Hospital |
| Condition | Knee Osteoarthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 230 participants |
| Start Date | 2026-06-26 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 230 participants in total. It began in 2026-06-26 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Güneş SARIKAYA
PRINCIPAL INVESTIGATOR
Balikesir Ataturk City Hospital
Frequently Asked Questions
Who can join the NCT07882316 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07882316 currently recruiting?
Yes, NCT07882316 is actively recruiting participants. Contact the research team at gunessarikaya05@hotmail.com for enrollment information.
Where is the NCT07882316 trial being conducted?
This trial is being conducted at Balıkesir, Turkey (Türkiye).
Who is sponsoring the NCT07882316 clinical trial?
NCT07882316 is sponsored by Balikesir Ataturk City Hospital. The principal investigator is Güneş SARIKAYA at Balikesir Ataturk City Hospital. The trial plans to enroll 230 participants.