Osteo Arthritis of the KneeNCT07553806
Evaluating the Clinical Impact of the Prehabilitation and Recovery for Enabling Potential (PREP) Clinical Care Pathway
An observational study of Osteo Arthritis of the Knee, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteo Arthritis of the Knee
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
- Unable, or unwilling to complete questionnaires throughout the duration of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
The Robert Jones and Agnes Hunt Orthopaedic Hospital
Oswestry, Shropshire, SY10 7AG
About this study
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.
Read the detailed description
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.
- Conditions
- Osteo Arthritis of the Knee
- Keywords
- Physiotherapy, Prehabilitation, Rehabilitation, Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veterans undergoing total knee replacement | Investigation of 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From time of total knee replacement, up to 12 months following surgery
Secondary outcomes (4)
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.
Measured: From baseline, up to 12 months post-surgery
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.
Measured: From baseline to 12 months post surgery
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
Measured: From surgery, up to and 12 months following TKR surgery.
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).
Measured: From baseline, up to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553806
- Sponsor's protocol ID
- RL1 934
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Impact of the Prehabilitation and Recovery for Enabling Potential (PREP) Clinical Care Pathway
- ClinicalTrials.gov ID
- NCT07553806
- Acronym / sponsor ID
- RL1 934
- Conditions
- Osteo Arthritis of the Knee
- Keywords
- Physiotherapy, Prehabilitation, Rehabilitation, Outcome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- May 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veterans undergoing total knee replacement | – | –Investigation of 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Unable, or unwilling to complete questionnaires throughout the duration of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical impact using the Oxford Knee Score
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.
4 secondary outcomes
Correlation of Baseline PANAS score and primary outcome - the Oxford Knee Score
Time frame: From baseline, up to 12 months post-surgery
Correlation of Baseline PANAS score and the PROM - The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Index
Time frame: From baseline to 12 months post surgery
Incidences of manipulations under anaesthetic
Time frame: From surgery, up to and 12 months following TKR surgery.
Practicality of delivering individualised prehabilitation and/or intensive post-operative rehabilitation
Time frame: From baseline, up to 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Osteo Arthritis of the Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis of the Knee, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marit N Dugard, PhD (+44 1691 404139, naomi.dugard@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical impact using the Oxford Knee Score (time frame: From time of total knee replacement, up to 12 months following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.