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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Total Knee Replacement
• Intervention / Treatment: Behavioral: Standard post-operative rehabilitation

• Study Type: Observational
• Enrollment (Actual): 364

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg Hospital, Department of Physical and Occupational Therapy
  • Copenhagen, Denmark, 2900
    • Gentofte Hospital, Department of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Oxford Knee Score	6 months after surgery
Oxford Knee Score	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient Acceptable Symptom State	6 and 12 months after surgery
EuroQoL questionnaire	6 and 12 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Marius Henriksen
• Investigators: Principal Investigator: Marius Henriksen, PT, PhD, Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: FYS002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon finalisation of the prespecified analyses we will share the IPD to other researchers based on an email inquiry.