Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty
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.
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.
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Güneş SARIKAYA
- 電話番号：05436733113
- メール：gunessarikaya05@hotmail.com
研究場所
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Balıkesir、トルコ（Türkiye）、+90(543)673-3113
- 募集
- Güneş Sarikaya
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コンタクト：
- Güneş SARIKAYA
- 電話番号：05436733113
- メール：gunessarikaya05@hotmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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WOMAC Physical Function Subscale Score at 12 Months
時間枠：12 months after surgery
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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. |
12 months after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in WOMAC Physical Function Score From Baseline
時間枠：Baseline (preoperative), 6 months and 12 months after surgery
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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. |
Baseline (preoperative), 6 months and 12 months after surgery
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協力者と研究者
捜査官
- 主任研究者：Güneş SARIKAYA、Balikesir Ataturk City Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- TKA-FCI-2026-01
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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