NCT07553806

Brief 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 outcomes, and whether these are sustained for up to 12 months post-surgery.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026May 2028

First Submitted

Initial submission to the registry

April 8, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 8, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

PhysiotherapyPrehabilitationRehabilitationOutcome

Outcome Measures

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.

    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

    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

    From baseline to 12 months post surgery

  • Incidences of manipulations under anaesthetic

    From surgery, up to and 12 months following TKR surgery.

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

    From baseline, up to 12 months post-surgery

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Robert Jones and Agnes Hunt Orthopaedic Hospital

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

Central Study Contacts

Marit N Dugard, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2026

First Posted

April 28, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations