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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

Tracking Information
First Submitted Date November 29, 2016
First Posted Date December 5, 2016
Last Update Posted Date February 5, 2020
Actual Study Start Date December 2016
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 2, 2016)
  • Oxford Knee Score [ Time Frame: 6 months after surgery ]
  • Oxford Knee Score [ Time Frame: 12 months after surgery ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 2, 2016)
  • Patient Acceptable Symptom State [ Time Frame: 6 and 12 months after surgery ]
  • EuroQoL questionnaire [ Time Frame: 6 and 12 months after surgery ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 5, 2016)
  • 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
  • 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.
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: December 2, 2016)
  • 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
  • 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", he/she 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", he/she 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.
  • Adverse events [ Time Frame: 6 and 12 months after surgery ]
    We will survey the participants for events that patients have experienced during the observation periodThese 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
 
Descriptive Information
Brief Title Knee Replacement Outcome Predicted by Physiotherapists
Official Title Knee Replacement Outcome Predicted by Physiotherapists: A Prospective Cohort
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Total Knee Replacement
  • Osteoarthritis
Intervention Behavioral: Standard post-operative rehabilitation
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 7, 2019)
364
Original Estimated Enrollment
 (submitted: December 2, 2016)
1000
Actual Study Completion Date December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02982785
Other Study ID Numbers FYS002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Marius Henriksen, Frederiksberg University Hospital
Study Sponsor Marius Henriksen
Collaborators Not Provided
Investigators
Principal Investigator: Marius Henriksen, PT, PhD Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
PRS Account Frederiksberg University Hospital
Verification Date February 2020