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Silkeborg Knee Replacement Cohort Study

30 de março de 2022 atualizado por: Central Jutland Regional Hospital
In this cohort study, we will investigate short and long term outcomes after knee replacement surgery and identify preoperative and early postoperative factors associated with long term outcome.

Visão geral do estudo

Descrição detalhada

All patients follow the same fast-track program including same day surgery for elective knee replacement surgery at the Silkeborg Regional Hospital in Denmark, which includes detailed preoperative written information, multidisciplinary education course for patients and relatives, optimized multimodal pain treatment and early postoperative rehabilitation. Before the admission for surgery, patients will be asked to fulfill several questionnaires and baseline information regarding work situation, educational level and previous treatments. At two weeks there, there is a scheduled follow up by a physical therapist and a nurse at the hospital. At three months there is a scheduled follow up by telephone with a physical therapist.

The study will adhere methodologically to the STROBE guidelines and checklist for prospective cohort studies (www.strobe-statement.org).

Further description is provided elsewhere as eligibility criteria and outcome measures.

Addition to the description:

In January 2019 we started collecting 1 year follow-up data and included questions regarding treatment success, satisfaction and willingness to repeat the surgery.

In March 2019 we decided to make a change in the baseline collection of relevant predictors for primary outcome. The reason for the change was to be able to answer more relevant scientific questions in the cohort study. We replaced "The General Self-efficacy Scale" with "Pain Catastrophizing Scale" and excluded "The General Self-efficacy Scale" from the 12 weeks follow-up collection of outcome measures.

March 2020:

The SIKS study was planned to continue recruitment until reaching minimum 1,000 TKA patients with follow-up data which was deemed sufficient for the purpose of the planned studies. In March 2020, the COVID-19 pandemic closed down all elective orthopaedic surgeries. Because of that, we decided to stop the recruitment to the cohort study with the last patient included (at March 16th, 2020, prior to the COVID-19 lockdown).

December 2020:

The first substudies are planned using data from the SIKS cohort:

  1. Predictors of knee pain and functional outcome following Total Knee Arthroplasty - a prospective cohort study with 12 months follow up

    Primary outcome:

    Oxford Knee Score at 12 months

  2. Is it feasible and safe to discharge patients on the day of surgery after a total knee arthroplasty?

    Primary outcomes Feasibility measured as length of stay Safety measures as readmission (phone calls, outpatient visits and inpatient visits) and the related reason

    Secondary outcomes Oxfort knee score (90 days) Pain intensity (90 days)

  3. Associations between preoperative BMI and postoperative physical activity level and functional capacity 12 months after UKA or TKA surgery.

Primary outcome UCLA scale (12 months)

Secondary outcomes Oxford Knee Score (12 months)

Tipo de estudo

Observacional

Inscrição (Real)

1225

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Jutland
      • Silkeborg, Jutland, Dinamarca, 8600
        • Silkeborg Regional Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Patients assigned for primary knee replacement in the period from February 2018 to May 2020 will be consecutively recruited to the cohort from Silkeborg Regional Hospital Denmark.

Descrição

Inclusion Criteria:

  • Assigned for primary Unicompartmental or Total Knee Replacement
  • Age ≥ 18 years at the time of recruitment
  • Able to read and understand Danish

Exclusion Criteria:

  • Not mentally able to reply to the questionnaire

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Knee replacement
Patients assigned for total or unicompartmental knee replacement surgery
Fast-track Knee replacement surgery including same day surgery

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Oxford Knee Score (OKS) (continous)
Prazo: 52 weeks after surgery
Disease specific Patient Reported Outcome Measure regarding function and pain. Each question is answered by ticking a box on a five-point Likert scale. Responses are then totalled to obtain a score between 0 and 48, with 48 being the best.
52 weeks after surgery

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Oxford Knee Score (OKS) (continous)
Prazo: Pre surgery
Disease specific Patient Reported Outcome Measure regarding function and pain. Each question is answered by ticking a box on a five-point Likert scale. Responses are then totalled to obtain a score between 0 and 48, with 48 being the best.
Pre surgery
Oxford Knee Score (OKS) (continous)
Prazo: 12 weeks after surgery
Disease specific Patient Reported Outcome Measure regarding function and pain. Each question is answered by ticking a box on a five-point Likert scale. Responses are then totalled to obtain a score between 0 and 48, with 48 being the best
12 weeks after surgery
EQ-5D-5L (continous)
Prazo: Pre surgery
Generic Health Related Quality of Life Patient Reported Outcome Measure
Pre surgery
EQ-5D-5L (continous)
Prazo: 12 weeks after surgery
Generic Health Related Quality of Life Patient Reported Outcome Measure
12 weeks after surgery
EQ-5D-5L (continous)
Prazo: 52 weeks after surgery
Generic Health Related Quality of Life Patient Reported Outcome Measure
52 weeks after surgery
The General Self-efficacy Scale (continous)
Prazo: Pre surgery
A generic Patient Reported Outcome Measure. The General Self-efficacy Scale measures self-efficacy, defined as an individual's belief in his or her capacity to execute behaviors necessary to produce specific performance attainments.Each question is answered by ticking a box on a four-point Likert scale. Responses are then totalled to obtain a score between 10 and 40, with 40 being the best. he General Self-efficacy Scale measures self-efficacy, defined as an individual's belief in his or her capacity to execute behaviors necessary to produce specific performance attainments.Each question is answered by ticking a box on a four-point Likert scale. Responses are then totalled to obtain a score between 10 and 40, with 40 being the best. The General Self-efficacy Scale is included in the data collection from January 2019 til March 2019, which corresponds to about 550 patient responds.
Pre surgery
The General Self-efficacy Scale (continous)
Prazo: 12 weeks after surgery
A generic Patient Reported Outcome Measure. The General Self-efficacy Scale measures self-efficacy, defined as an individual's belief in his or her capacity to execute behaviors necessary to produce specific performance attainments. Each question is answered by ticking a box on a four-point Likert scale. Responses are then totalled to obtain a score between 10 and 40, with 40 being the best. The General Self-efficacy Scale is included in the data collection from January 2019 til June 2019, which corresponds to about 550 patient responds
12 weeks after surgery
Pain Visual Analog Scale (VAS) (continous)
Prazo: Pre surgery
Measured in rest and activity. The pain VAS is a generic pain measure on a continuous scale comprised of a horizontal line orientated from the left (worst) to the right (best), 100 mm in length
Pre surgery
Pain Visual Analog Scale (VAS) (continous)
Prazo: 12 weeks after surgery
Measured in rest and activity. The pain VAS is a generic pain measure on a continuous scale comprised of a horizontal line orientated from the left (worst) to the right (best), 100 mm in length
12 weeks after surgery
Pain Visual Analog Scale (VAS) (continous)
Prazo: 52 weeks after surgery
Measured in rest and activity. The pain VAS is a generic pain measure on a continuous scale comprised of a horizontal line orientated from the left (worst) to the right (best), 100 mm in length
52 weeks after surgery
Analgetic pain medication intake (type and frequence)
Prazo: Pre surgery
Self-reported by the patients
Pre surgery
Analgetic pain medication intake (type and frequence)
Prazo: 12 weeks after surgery
Self-reported by the patients
12 weeks after surgery
Analgetic pain medication intake (type and frequence)
Prazo: 52 weeks after surgery
Self-reported by the patients
52 weeks after surgery
Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)
Prazo: Pre surgery
Measures is conducted by a doctor
Pre surgery
UCLA Activity Scale (continuous)
Prazo: Pre surgery
Patient Reported Outcome Measure, that measures physical activity in patients with knee replacements on a 10-level scale, where "10" is very active
Pre surgery
UCLA Activity Scale (continuous)
Prazo: 12 weeks after surgery
Patient Reported Outcome Measure, that measures physical activity in patients with knee replacements on a 10-level scale, where "10" is very active
12 weeks after surgery
UCLA Activity Scale (continuous)
Prazo: 52 weeks after surgery
Patient Reported Outcome Measure, that measures physical activity in patients with knee replacements on a 10-level scale, where "10" is very active
52 weeks after surgery
Pain Catastrophizing Scale (PCS)
Prazo: Pre surgery
Patient Reported Outcome Measure, that measures how patients experience pain. Pain catastrophizing is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event such as surgery for example. Each of the 13 questions is answered by ticking a box on a 5 point Likert Scale from 0 (not at all) to 4 (all the time). A total score is yielded (ranging from 0-52 and 0 being the best), along with three subscale scores assessing rumination, magnification and helplessness. The PCS is included in the data collection from March 2019 til end of the cohort study, which corresponds to about 950 patient responses (instead of The General Self-efficacy Scale)
Pre surgery
Global Perceived Effect (GPE)
Prazo: 52 weeks after surgery
GPE measures patients' perception of the change in their knee problems after the surgery. GPE will be assessed with the anchor question "Overall, how are the problems now (pain and ability to perform daily activities) in the knee on which you had surgery, compared to prior to your operation?" Patients respond on a 7-point scale ranging from "better, an important improvement" to "worse, an important deterioration".
52 weeks after surgery
Satisfaction with the surgery
Prazo: 52 weeks after surgery
Satisfaction is measured with the question "Overall, how satisfied are you with the sugery?". Patients respond on a 5 point scale ranging from "very satisfied" to "very unsatisfied"
52 weeks after surgery
Patient Acceptable Symptom State (PASS)
Prazo: 52 weeks after surgery
PASS measures satisfaction with the current knee function and will be assessed with the anchor question ""When you think of your knee function, will you consider your current condition as satisfying? With knee function, you should take into account your activities of daily living, your level of pain and other symptoms". Patients respond "yes" or "no". If patients respond "no" they are asked if the consider the treatment of ther knee problem as a failure.
52 weeks after surgery
Global assessment of willingness to repeat the surgery
Prazo: 52 weeks after surgery
Assessed with the anchor question "knowing what your knee arthroplasty surgery did for you, if you could go back in time, would you still have undergone this surgery?" Patients respond "yes", "no" or "uncertain".
52 weeks after surgery
Feasibility (length of stay)
Prazo: 2 weeks after surgery
Measured as length of stay and reason for not being discharged on post operative day 0 (same-day) will be provided.
2 weeks after surgery
Safety (readmission)
Prazo: 1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge
  1. number of patient-initiated phone calls
  2. number of unscheduled visits in the outpatient clinic
  3. number of inpatient readmission (admission to hospital ward taking up a bed)
1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge
Safety (complications)
Prazo: 1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge

The reason for readmission (=complication) in relation to:

  1. patient-initiated phone calls
  2. unscheduled visits in the outpatient clinic
  3. inpatient readmission (admission to hospital ward taking up a bed) will be reported.
1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Pain Visual Analog Scale (VAS) (continous)
Prazo: 2 weeks after surgery
Measured in rest and activity. The pain VAS is a generic pain measure on a continuous scale comprised of a horizontal line orientated from the left (worst) to the right (best), 100 mm in length
2 weeks after surgery
Analgetic pain medication intake (type and frequence)
Prazo: 2 weeks after surgery
Registrated by a nurse
2 weeks after surgery
Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)
Prazo: 2 weeks after surgery
Measures is conducted by a physical therapist
2 weeks after surgery
Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)
Prazo: pre surgery
Measures is conducted by a doctor
pre surgery

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Lone Ramer Mikkelsen, Msc., Ph.D., Interdisciplinary Research Unit Elective Surgery Centre Silkeborg Regional Hospital, Denmark
  • Investigador principal: Mette Garval, PT, Msc., Physical Therapy Department, Elective Surgery Centre Silkeborg Regional Hospital, Denmark
  • Cadeira de estudo: Søren Thorgaard Skou, PT, PhD, Research Unit for Musculoskeletal Function and Physiotherapy University of Southern Denmark
  • Investigador principal: Anne Mette Schmidt, Msc., Ph.D., Interdisciplinary Research Unit Elective Surgery Centre Silkeborg Regional Hospital, Denmark

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de fevereiro de 2018

Conclusão Primária (Real)

23 de março de 2021

Conclusão do estudo (Real)

23 de março de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

19 de janeiro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de janeiro de 2018

Primeira postagem (Real)

25 de janeiro de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de abril de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de março de 2022

Última verificação

1 de maio de 2020

Mais Informações

Termos relacionados a este estudo

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Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Total or unicompartmental knee replacement

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