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

10 de agosto de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Actual)

179

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • New York
      • New York, New York, Estados Unidos
        • Hospital for Special Surgery

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Procedimiento: Total Knee Arthroplasty
Patients will undergo total unilateral knee arthroplasty for osteoarthritis.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Presence of persistent postoperative pain using the numeric rating scale (NRS)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of postoperative joint stiffness
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hospital for Special Surgery, New York

Investigadores

  • Investigador principal: Meghan Kirksey, MD, PhD, Hospital for Special Surgery, New York

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de diciembre de 2015

Finalización primaria (Anticipado)

1 de julio de 2022

Finalización del estudio (Anticipado)

1 de julio de 2022

Fechas de registro del estudio

Enviado por primera vez

8 de diciembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

9 de diciembre de 2015

Publicado por primera vez (Estimar)

10 de diciembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de agosto de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

10 de agosto de 2021

Última verificación

1 de agosto de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2015-361

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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