Knee Replacement Outcome Predicted by Physiotherapists

Osteoarthritis Clinical Trial

Official title:

Knee Replacement Outcome Predicted by Physiotherapists: A Prospective Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982785
• Other study ID #: FYS002
• Status: Completed
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Total Knee Replacement

Intervention

Behavioral:
• Standard post-operative rehabilitation

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Department of Physical and Occupational Therapy	Copenhagen
Denmark	Gentofte Hospital, Department of Physical Therapy	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Marius Henriksen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire regarding postoperative rehabilitation	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	6 and 12 months after surgery
Other	Transition ratings of global perceived effect	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.	6 and 12 months after surgery
Other	Adverse events	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	6 and 12 months after surgery
Primary	Oxford Knee Score		6 months after surgery
Primary	Oxford Knee Score		12 months after surgery
Secondary	Patient Acceptable Symptom State		6 and 12 months after surgery
Secondary	EuroQoL questionnaire		6 and 12 months after surgery