Evaluating the Clinical Impact of the Prehabilitation and Recovery for Enabling Potential (PREP) Clinical Care Pathway

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorRobert Jones and Agnes Hunt Orthopaedic and District NHS Trust

About this trial

The Evaluating PREP Study aims to determine in whether the PREP Programme has an impact on clinical outcomes for Veterans undergoing TKR. Specifically, we are exploring whether prehabilitation and a week long intense individualised rehabilitation period after TKR surgery has a positive impact on functional and mental outcomes, and whether these are sustained for up to 12 months post-surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Must be a Veteran under the clinical care of an RJAH Veterans Orthopaedic Consultant and participating in the PREP Programme.

Able to read and speak English.

Able to demonstrate capacity to provide informed consent.

Disqualifiers

Subject is under 18 years of age.

Subject is not a Veteran, not under the care of an RJAH Veteran's Orthopaedic Consultant, or is not participating in the PREP Programme.

Unable to read and speak English.

Unable to demonstrate capacity to provide informed consent.

Trial population

Potential participants will be identified from clinic lists at the Veterans Orthopaedic Service, Robert Jones and Agnes Hunt Orthopaedic Hospital. Patients that are Veterans, that have been listed for a total knee replacement surgery at the hospital and also agreed to enter into the PREP clinical pathway programme will be eligible to take part in this research study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 1 trial group
Group A: Veterans undergoing total knee replacement

Trial outcomes

Primary outcomes

1

Clinical impact using the Oxford Knee Score

To evaluate the clinical impact, using the Oxford Knee Score, of the PREP Programme for Veterans up to 1 year following total knee replacement surgery. The Oxford Knee Score (OKS) is a 12-item patient-reported outcome measure (PROM) developed by the University of Oxford designed to assess knee pain and function, primarily in patients undergoing knee replacement surgery or managing knee osteoarthritis. Each question is scored 0-4, giving a total score from 0 (severe knee problems) to 48 (satisfactory joint function). Higher scores indicate better knee health.

Time frame
From time of total knee replacement, up to 12 months following surgery

Secondary outcomes

1

Correlation of Baseline PANAS score and primary outcome - the Oxford Knee Score

To evaluate the association between baseline Positive and Negative Affect Schedule (PANAS) score and the Oxford Knee Score (OKS), and determine whether observed effects are sustained up to 12 months post-surgery The PANAS is a 20-item self-report measure to assess positive affect (PA) and negative affect (NA). PA is associated with pleasurable engagement with the environment, whereas NA reflects a dimension of a variety of negative states such as anger, guilt, or anxiety. 10 questions relate to PA and 10 to NA, each question is scored from 1 (Very slightly or not at all) to 5 (Extremely). PA scores are combined and range from 10-50, higher scores representing higher levels of positive affect. NA scores are combined and range from 10-50, lower scores representing lower levels of negative affect. The study will assess: Whether better outcome at 12 month (using the OKS; higher scores indicate better knee health) is observed in patients with higher PA and lower NA baseline scores.

Time frame
From baseline, up to 12 months post-surgery
2

Correlation of Baseline PANAS score and the PROM - The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Index

To evaluate the association between baseline PANAS score and the WOMAC Osteoarthritis Index. The PANAS is described in 3. above. The WOMAC is widely used in the evaluation of Knee Osteoarthritis. The self-administered questionnaire consists of 24 items divided into 3 subscales: pain (5 items), Stiffness (2 items) and Physical Function (17 items). Questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score; higher scores indicating worse pain, stiffness, and functional limitations. The study will assess: Whether better clinical outcome at 12 months post surgery (using the WOMAC Index; lower scores indicate better knee health) is observed in patients with higher PA scores and lower NA scores at baseline.

Time frame
From baseline to 12 months post surgery
3

Incidences of manipulations under anaesthetic

To determine whether an individualised prehabilitation and/or post-operative rehabilitation reduces the incidences of manipulations under anaesthetic (MUAs) in Veterans undergoing a TKR

Time frame
From surgery, up to and 12 months following TKR surgery.
4

Practicality of delivering individualised prehabilitation and/or intensive post-operative rehabilitation

To determine the practicality of delivering an individualised prehabilitation and/or intensive post-operative rehabilitation in Veterans who have undergone a total knee replacement (TKR).

Time frame
From baseline, up to 12 months post-surgery

Other outcomes

Sponsors and contacts

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