Physiotherapy rehabilitation post patellar dislocation – is a full-scale trial feasible?
| ISRCTN | ISRCTN14235231 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14235231 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 312280 |
| Protocol serial number | IRAS 312280, CPMS 53637 |
| Sponsor | University of Oxford |
| Funder | National Institute for Health and Care Research |
- Submission date
- 05/07/2022
- Registration date
- 09/08/2022
- Last edited
- 28/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
The kneecap (patella) is a round shaped bone at the front of the knee. Normally, the kneecap sits in a groove in the thigh bone. Kneecap dislocations occur when the kneecap moves out of this groove. This is a sudden painful injury and most people need to go the Emergency Department. To help them recover, patients are normally referred to a physiotherapist. After assessing the injury, physiotherapists give patients advice and exercises to do to help them return to their normal activities. Unfortunately, not everyone recovers fully. Sometimes the knee remains painful or the kneecap dislocates again. Occasionally, people need to have surgery.
At the moment, we do not know if giving patients more physiotherapy sessions makes a difference to how well they recover after a kneecap dislocation. To find this out we would need to compare different physiotherapy treatments in a large study. To decide if a large study would work, we first need to compare these treatments in this smaller study.
Who can participate?
Patients at least 14 years old who have had a recent kneecap dislocation
What does the study involve?
Patients who take part will be allocated at random to one of two physiotherapy treatments:
1. “Self-managed rehabilitation”. This involves one session with a physiotherapist who will give participants advice and exercises to help them recover. Participants will then manage their own recovery by following advice and exercises available on a study website. If participants are struggling, they can contact the physiotherapist for advice or to arrange an additional session.
2. “Supervised rehabilitation”. This involves 4-6 physiotherapy sessions over a maximum of six months. These participants will also have access to the advice and exercises on the study website. The additional sessions in this treatment will enable the physiotherapist to tailor and progress participants’ exercises to try and prepare them for the activities they want to return to.
We will ask participants to complete questionnaires when they join the study, then 3, 6 and 9 months later. We will send questionnaires to participants by email and/or text message, or by post if they cannot complete questionnaires online.
We will also interview up to 20 patients, including patients who decline to take part in the study, to understand what they thought of the study, and their experience of injury, treatment, and recovery.
What are the possible benefits and risks of participating?
The main benefit from this study is it will help us decide if a future larger study in this area will work, and if so, what we need to change to make this future study better. This later larger study will find out which physiotherapy treatment is better for patients with a recent kneecap dislocation who are treated in the NHS.
People who participate are unlikely to be harmed by the treatments in this study. The study treatments are within the range of normal physiotherapy treatment provided for patients with a recent kneecap dislocation in the NHS. The study treatments will be provided by registered and fully-qualified physiotherapists. Participants may experience some soreness after completing exercises, but they will be given advice on how to manage this. For some people, talking about their experience can bring back memories and feelings. If this happens the researcher will provide support, offer a break, or offer to continue the interview at another time. Participants can choose not to answer any questions and can stop the interview whenever they want to.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
October 2021 to September 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Colin Forde, prepped@ndorms.ox.ac.uk
Contact information
Public
Kadoorie Centre
Level 3
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0003-0749-1298 |
|---|---|
| Phone | +44 (0)1865740328 |
| prepped@ndorms.ox.ac.uk |
Scientific
Kadoorie Centre
Level 3
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865740328 |
|---|---|
| colin.forde@ndorms.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre parallel two-arm external pilot randomized controlled trial and qualitative study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | PRePPeD - Physiotherapy Rehabilitation Post Patellar Dislocation: supervised versus self-managed rehabilitation for people after acute patellar dislocation: a multicentre external pilot randomised controlled trial and qualitative study |
| Study acronym | PRePPeD |
| Study objectives | Is it possible to conduct a full-scale trial comparing the clinical and cost-effectiveness of supervised versus self-managed rehabilitation for people after acute patellar dislocation? |
| Ethics approval(s) | Approved 25/08/2022, East of Scotland Research Ethics Service (Ninewells Hospital & Medical School, Tayside Medical Science Centre (TASC), Residency Block, Level 3, George Pirie Way, Dundee, DD1 9SY, UK; +44 (0)1382 383871; tay.eosres@nhs.scot), ref: 22/ES/0035 |
| Health condition(s) or problem(s) studied | Patients aged 14 years or older with an acute first-time or recurrent patellar dislocation |
| Intervention | Participants will be randomly allocated 1:1 using a web-based service to “supervised rehabilitation” or “self-managed rehabilitation”. Randomisation will be stratified by study site and first-time/recurrent dislocation. 1. Self-managed rehabilitation involves a single physiotherapy session of advice and exercise lasting up to 60 minutes. Participants will then self-manage their recovery following advice and exercise videos on a study website. If participants are struggling with exercise technique or progression, they can initiate one follow-up physiotherapy session. 2. Supervised rehabilitation involves 4-6 physiotherapy sessions of advice and exercise over a maximum of 6 months. Initial sessions will last up to 60 minutes and follow-up sessions will last up to 30 minutes. The additional sessions will enable physiotherapists to re-assess participants, prescribe an individually tailored exercise programme, and help participants solve any problems. Participants will also have access to advice and exercise videos on the study website. |
| Intervention type | Behavioural |
| Primary outcome measure(s) | This study aims to determine if a full-scale randomised controlled trial comparing supervised versus self-managed rehabilitation for people after acute patellar dislocation is feasible by assessing the: 1. Willingness to be randomised: proportion of eligible patients approached who are randomised over the recruitment period; 2. Recruitment rate: number of participants recruited per month per site over the recruitment period; 3. Intervention adherence: proportion of participants allocated to “supervised rehabilitation” and “self-managed rehabilitation” attending at least four physiotherapy sessions and one physiotherapy session, respectively; 4. Retention: proportion of participants that return KOOS4 outcome data at 9 months; and 5. Understanding participants’ experience of recovery, and the acceptability of the study interventions and follow-up methods to participants through semi-structured interviews conducted over the 9-month follow-up period |
| Key secondary outcome measure(s) | To assess if the planned outcomes for the full-scale trial can be collected, we will collect them in this study. Secondary outcome measures are: 1. Knee symptoms and function measured by the average of four of five domains of the Knee Osteoarthritis Outcome Score (KOOS4) and all KOOS subdomains at baseline and 3, 6, and 9 months after randomisation 2. Health-related quality of life measured using the EuroQol 5 Dimensions (EQ-5D-5L) at baseline, and 3, 6 and 9 months after randomisation 3. Return to pre-injury sport/physical activity level using a using a trial specific questionnaire at baseline, and 3, 6 and 9 months after randomisation 4. Global rating of change measured using participant-reported rating of change in their injured knee compared to when they agreed to enter the study on a 7-point Likert Scale at 3, 6, and 9 months after randomisation 5. Adherence to prescribed exercise using a trial specific questionnaire at 3, 6 and 9 months after randomisation 6. Health resource use using a trial specific questionnaire at 3, 6 and 9 months after randomisation 7. Complications using a trial specific questionnaire and site reporting at 3, 6 and 9 months after randomisation |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 14 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Aged ≥14 years 2. First-time or recurrent patellar dislocation confirmed if: 2.1. The patellar dislocation was reduced by a healthcare professional or 2.2. The patient reports a visible lateral patellar dislocation or sensation of the patella ‘popping out’ of joint followed by reduction and the assessing clinician diagnoses a lateral patellar dislocation 3. Willing and able to provide informed consent (patients aged ≥16 years), or for patients aged <16 years the parent is willing and able to provide informed consent for their child’s participation and the patient is able to provide assent should they wish to do so |
| Key exclusion criteria | 1. >14 days from injury 2. Previous patellar stabilisation surgery on the affected knee 3. Requires acute surgical intervention (e.g., due to concurrent osteochondral fracture) 4. Contraindication(s) to participation in the study interventions 5. Patient is unable to adhere to study procedures 6. Previously randomised into the study |
| Date of first enrolment | 12/12/2022 |
| Date of final enrolment | 29/08/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Headington
Oxford
OX3 9DU
United Kingdom
Banbury
OX16 9AL
United Kingdom
Bath
BA1 3NG
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Colin Forde (colin.forde@ndorms.ox.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 10/07/2023 | 11/07/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.0 | 05/07/2022 | 15/07/2022 | No | No |
| Protocol file | version 3.0 | 03/11/2022 | 18/11/2022 | No | No |
| Protocol file | version 4.0 | 17/05/2023 | 19/07/2023 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
Editorial Notes
28/01/2025: The intention to publish date was changed from 01/01/2025 to 01/07/2025.
25/09/2024: The intention to publish date was changed from 01/12/2024 to 01/01/2025.
04/09/2023: The following changes were made:
1. The total final enrolment was added.
2. The recruitment end date was charged from 18/09/2023 to 29/08/2023.
19/07/2023: Uploaded protocol v4.0 (not peer-reviewed) as an additional file.
11/07/2023: Publication reference added.
14/12/2022: The trial participating centre South Tyneside & Sunderland NHS Foundation Trust was added.
12/12/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/12/2022 to12/12/2022.
2. The trial website was added.
3. The participant level data sharing statement was added.
4. The ethics approval was added.
21/11/2022: The recruitment start date has been changed from 19/09/2022 to 01/12/2022.
18/11/2022: Protocol uploaded (not peer reviewed). Horton General Hospital and Royal United Hospitals Bath NHS Foundation Trust were added as trial participating centres.
15/07/2022: Trial's existence confirmed by the NIHR.
