- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02982785
Knee Replacement Outcome Predicted by Physiotherapists
Knee Replacement Outcome Predicted by Physiotherapists: A Prospective Cohort
The aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards can predict the future course (post hospitalisation) of recovery of patients undergoing KA. The prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor prognosis; 10=best prognosis).
To identify candidate prognostic factors, the therapist are asked to qualify their prognosis narratively, by listing at least 3-5 factors that they consider important for their projected prognosis score. There will be no maximum number of factors the physiotherapist can list.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Copenhagen, Danmark, 2400
- Bispebjerg Hospital, Department of Physical and Occupational Therapy
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Copenhagen, Danmark, 2900
- Gentofte Hospital, Department of Physical Therapy
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Patients undergoing primary total knee arthroplasty (TKA) for treatment of knee osteoarthritis. All patients from december 2016 to december 2017 will be invited to participate.
If it is not possible to reach the set sample size within the set timeframe, recruitment will continue until the numbers specified in the a priori sample size calculation are reached. Should the set sample size be reached ahead of time, recruitment will stop.
Beskrivelse
Inclusion Criteria:
- Received primary knee replacement surgery for knee OA
- Age ≥ 18 years
- Reads and speaks Danish
- Has an email address
- Signed informed consent
Exclusion Criteria:
- Cognitive impairments that preclude reliable answers to online questionnaires (e.g. dementia)
- Revision surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Oxford Knee Score
Tidsramme: 6 months after surgery
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6 months after surgery
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Oxford Knee Score
Tidsramme: 12 months after surgery
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12 months after surgery
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Patient Acceptable Symptom State
Tidsramme: 6 and 12 months after surgery
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6 and 12 months after surgery
|
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EuroQoL questionnaire
Tidsramme: 6 and 12 months after surgery
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6 and 12 months after surgery
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Questionnaire regarding postoperative rehabilitation
Tidsramme: 6 and 12 months after surgery
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This is a questionnaire that includes questions regarding the postoperative rehabilitation (i.e., setting, participation, type, duration, frequency, and degree of supervision).
Details from post-operative rehabilitation provided at one of the investigational sites will be obtained from the patients' hospital records
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6 and 12 months after surgery
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Transition ratings of global perceived effect
Tidsramme: 6 and 12 months after surgery
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This is a transition questionnaire on which the participants initially answers if their current state is "unchanged, worse" or "better" compared to pre-surgery.
An "unchanged" equals a transition score of 0. If the participant answers "worse", the participant is asked to rate the degree of worsening on a 7 point Likert scale, and the corresponding scores range from -1 to -7.
Correspondingly, if a participant answers "better", the participant is asked to rate the degree of improvement on a 7 point Likert scale, and the corresponding scores range from 1 to 7. Thus the global perceived effect score range from -7 (worsening) to 7 (improvement), with the mid-point - 0 - representing no change.
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6 and 12 months after surgery
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Adverse events
Tidsramme: 6 and 12 months after surgery
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Survey of the participants for events that patients have experienced during the observation period.
These events will be self-reported using a questionnaire with ample space for free text.
An event will be defined as causing limitations in daily activities, Sports/Recreational activities or work limitations together with symptoms causing participants to seek medical care.
The events may be unrelated to the knee (such as development or exacerbation of comorbidities) and the events are not necessarily causally linked to the knee surgery
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6 and 12 months after surgery
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Marius Henriksen, PT, PhD, Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FYS002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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