The Robert Jones and Agnes Hunt Orthopaedic Hospital
Oswestry, Shropshire, SY10 7AG, United Kingdom
NCT Number: NCT07553806
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.
Trial opening soon.
Get Notified18 year–100 year
All sexes
Observational
Oswestry, Shropshire, SY10 7AG, United Kingdom
There is compelling clinical, methodological, and service-level rationale to implement and evaluate a veteran-specific prehabilitation and rehabilitation pathway. This proposed service, The Prehabilitation and Recovery for Enabling Potential (PREP) Programme, incorporates standardized outcome measures aligned with core domains for Total Knee Replacement (TKR), and addresses the biopsychosocial complexity unique to veteran populations. The PREP Programme aims not only to improve patient-level outcomes but also to contribute meaningful data to an underrepresented area of Orthopaedic rehabilitation research.
The Evaluating PREP Research Study aims to determine in real-time whether the PREP Programme has an impact on clinical outcomes for Veterans undergoing TKR, and whether these are sustained for up to 12 months post-surgery.
The research study plans to collect data from people undergoing the PREP Programme by extracting clinical data as they move through the clinical prehabilitation and rehabilitation programme. The study will also collect data from an additional questionnaire.
Understanding whether individualised prehabilitation prior to TKR and intensive rehabilitation following surgery influences both physical and mental outcomes for Veteran patients could help improve surgical management in the future, leading to better outcomes for this patient population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From time of total knee replacement, up to 12 months following surgery
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 baseline, up to 12 months post-surgery
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 to 12 months post surgery
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 surgery, up to and 12 months following TKR surgery.
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 baseline, up to 12 months post-surgery
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).
Contact information is provided by the study sponsor or research team.
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Other Gov
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