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Knee Replacement Outcome Predicted by Physiotherapists

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ClinicalTrials.gov Identifier: NCT02982785
Recruitment Status : Completed
First Posted : December 5, 2016
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Total Knee Replacement Osteoarthritis Behavioral: Standard post-operative rehabilitation

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Study Type : Observational
Actual Enrollment : 364 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Knee Replacement Outcome Predicted by Physiotherapists: A Prospective Cohort
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement




Primary Outcome Measures :
  1. Oxford Knee Score [ Time Frame: 6 months after surgery ]
  2. Oxford Knee Score [ Time Frame: 12 months after surgery ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  1. Received primary knee replacement surgery for knee OA
  2. Age ≥ 18 years
  3. Reads and speaks Danish
  4. Has an email address
  5. Signed informed consent

Exclusion Criteria:

  1. Cognitive impairments that preclude reliable answers to online questionnaires (e.g. dementia)
  2. Revision surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982785


Locations
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Denmark
Bispebjerg Hospital, Department of Physical and Occupational Therapy
Copenhagen, Denmark, 2400
Gentofte Hospital, Department of Physical Therapy
Copenhagen, Denmark, 2900
Sponsors and Collaborators
Marius Henriksen
Investigators
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Principal Investigator: Marius Henriksen, PT, PhD Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
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Responsible Party: Marius Henriksen, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT02982785    
Other Study ID Numbers: FYS002
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon finalisation of the prespecified analyses we will share the IPD to other researchers based on an email inquiry.
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases