Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty

31. oktober 2026 opdateret af: güneş sarıkaya, Balikesir Ataturk City Hospital

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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Anslået)

230

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
WOMAC Physical Function Subscale Score at 12 Months
Tidsramme: 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.
12 months after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in WOMAC Physical Function Score From Baseline
Tidsramme: Baseline (preoperative), 6 months and 12 months after surgery

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Balikesir Ataturk City Hospital

Efterforskere

  • Ledende efterforsker: Güneş SARIKAYA, Balikesir Ataturk City Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. juni 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

13. oktober 2026

Først indsendt, der opfyldte QC-kriterier

13. oktober 2026

Først opslået (Faktiske)

20. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TKA-FCI-2026-01

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner