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OpenTrials
Completed

NCT Number: NCT02982785

Knee Replacement Outcome Predicted by Physiotherapists

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital, Department of Physical and Occupational Therapy, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard post-operative rehabilitation

Behavioral

Primary outcomes

  1. Oxford Knee Score

    Time frame: 6 months after surgery

  2. Oxford Knee Score

    Time frame: 12 months after surgery

Secondary outcomes

  1. Patient Acceptable Symptom State

    Time frame: 6 and 12 months after surgery

  2. EuroQoL questionnaire

    Time frame: 6 and 12 months after surgery

Other outcomes

  1. Questionnaire regarding postoperative rehabilitation

    Time frame: 6 and 12 months after surgery

    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

  2. Transition ratings of global perceived effect

    Time frame: 6 and 12 months after surgery

    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.

  3. Adverse events

    Time frame: 6 and 12 months after surgery

    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

Sponsors and collaborators

Lead sponsor

Marius Henriksen

Other

Registry information

Official study title

Knee Replacement Outcome Predicted by Physiotherapists: A Prospective Cohort

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2016
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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