Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis (Pain+Stiffness)

10 agosto 2021 aggiornato da: Hospital for Special Surgery, New York
Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty. There is growing evidence that inflammation as well as other medical and psychological factors may be associated with osteoarthritis severity, progression, and associated pain severity. This study aims to identify clinical, biological, and psychological factors that contribute to and predict the development of these complications. Identification of such factors may allow us to target preventative measures to the patients at highest risk of persistent postoperative pain and joint stiffness.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Effettivo)

179

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • New York
      • New York, New York, Stati Uniti
        • Hospital For Special Surgery

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Hospital for Special Surgery patients scheduled to undergo unilateral total knee arthroplasty under regional anesthesia.

Descrizione

Inclusion Criteria:

  • Elective primary unilateral total knee arthroplasty
  • Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint
  • Patients of surgeons who have agreed to participate in the study
  • Age > 18 years
  • American Society of Anesthesiologists (ASA) Physical Status 1-3
  • Regional anesthesia
  • Epidural patient-controlled analgesia (PCA) for postoperative pain
  • Adductor canal block for postoperative pain

Exclusion Criteria:

  • Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
  • Use of general anesthesia
  • History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids
  • Preoperative oral steroid use in the past 6 months
  • Intra-articular steroid injection within one month of scheduled surgery in affected joint
  • Non-English speakers
  • Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
  • Peri-articular injections or infusions for postoperative pain
  • Diagnosis of crystalline arthropathy
  • Diagnosis of osteonecrosis
  • Active infection or use of antibiotics
  • Pregnant women

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Total knee arthroplasty patients
Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.
Procedura: Total Knee Arthroplasty
Patients will undergo total unilateral knee arthroplasty for osteoarthritis.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Presence of persistent postoperative pain using the numeric rating scale (NRS)
Lasso di tempo: 6 months after date of surgery
Defined as numeric rating scale (NRS) pain score ≥4 with activity in the operated joint
6 months after date of surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of postoperative joint stiffness
Lasso di tempo: 6 weeks after date of surgery
Number of patients that experience postoperative joint stiffness, defined as ≤95 degrees range of motion.
6 weeks after date of surgery
Postoperative knee range of motion
Lasso di tempo: 6 weeks after date of surgery
Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees.
6 weeks after date of surgery
NRS pain at rest on POD1
Lasso di tempo: 1 day after surgery
NRS pain at rest on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
1 day after surgery
NRS pain with movement on POD1
Lasso di tempo: 1 day after surgery
NRS pain with movement on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
1 day after surgery
Worst NRS pain on POD1
Lasso di tempo: 1 day after surgery
Worst NRS pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
1 day after surgery
Least NRS pain on POD1
Lasso di tempo: 1 day after surgery
Least NRS pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
1 day after surgery
NRS pain at rest on POD2
Lasso di tempo: 2 days after surgery
NRS pain at rest on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
2 days after surgery
NRS pain with movement on POD2
Lasso di tempo: 2 days after surgery
NRS pain with movement on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
2 days after surgery
Worst NRS pain on POD2
Lasso di tempo: 2 days after surgery
Worst NRS pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
2 days after surgery
Least NRS pain on POD2
Lasso di tempo: 2 days after surgery
Least NRS pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
2 days after surgery
NRS pain at rest 4 weeks after surgery
Lasso di tempo: 4 weeks after surgery
NRS pain at rest on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
4 weeks after surgery
NRS pain with movement 4 weeks after surgery
Lasso di tempo: 4 weeks after surgery
NRS pain with movement on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
4 weeks after surgery
Worst NRS pain 4 weeks after surgery
Lasso di tempo: 4 weeks after surgery
Worst NRS pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
4 weeks after surgery
Least NRS pain 4 weeks after surgery
Lasso di tempo: 4 weeks after surgery
Least NRS pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
4 weeks after surgery
NRS pain at rest 3 months after surgery
Lasso di tempo: 3 months after surgery
NRS pain at rest 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
3 months after surgery
NRS pain with movement 3 months after surgery
Lasso di tempo: 6 weeks after date of surgery
NRS pain with movement 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
Worst NRS pain 3 months after surgery
Lasso di tempo: 6 weeks after date of surgery
Worst NRS pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
Least NRS pain 3 months after surgery
Lasso di tempo: 6 weeks after date of surgery
Least NRS pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
NRS pain at rest 6 months after surgery
Lasso di tempo: 6 weeks after date of surgery
NRS pain at rest 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
Least NRS pain 6 months after surgery
Lasso di tempo: 6 weeks after date of surgery
Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
Worst NRS pain 6 months after surgery
Lasso di tempo: 6 weeks after date of surgery
Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
Postoperative knee range of motion
Lasso di tempo: 6 weeks after date of surgery
Range of motion (extension minus flexion) at patients postoperative 6 week appointment. Measured by the surgeon or surgical staff. Measured in degrees.
6 weeks after date of surgery
Postoperative KOOS scores
Lasso di tempo: 4 weeks, 3 months, and 6 months after date of surgery
4 weeks, 3 months, and 6 months after date of surgery
Postoperative painDETECT scores
Lasso di tempo: 4 weeks, 3 months, and 6 months after date of surgery
Neuropathic pain assessment
4 weeks, 3 months, and 6 months after date of surgery
Time to attainment of inpatient physical therapy goals
Lasso di tempo: During inpatient hospital stay, approximately 3 days after date of surgery
Goals include ambulation of 40 feet and independent transfer.
During inpatient hospital stay, approximately 3 days after date of surgery
Types of postoperative medications
Lasso di tempo: 1 day, 2 days, 4 weeks, 3 months, and 6 months after date of surgery
Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications.
1 day, 2 days, 4 weeks, 3 months, and 6 months after date of surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospital for Special Surgery, New York

Investigatori

  • Investigatore principale: Meghan Kirksey, MD, PhD, Hospital for Special Surgery, New York

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 dicembre 2015

Completamento primario (Anticipato)

1 luglio 2022

Completamento dello studio (Anticipato)

1 luglio 2022

Date di iscrizione allo studio

Primo inviato

8 dicembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

9 dicembre 2015

Primo Inserito (Stima)

10 dicembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 agosto 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 agosto 2021

Ultimo verificato

1 agosto 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2015-361

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dolore

Prove cliniche su Total Knee Arthroplasty

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Spain

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi