Patella DislocationINDEX-KDNCT03798483

INDividualised EXercise for Kneecap Dislocations

A study testing Individualised exercise in people with Patella Dislocation and Patella Dislocation Recurrent, run by City, University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: Patella Dislocation, Patella Dislocation Recurrent
What is being tested?: Individualised exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited Kingdom
Study dates: 24 Jan 2019to 15 Oct 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

First time or recurrent lateral patella dislocation meeting the diagnostic criteria of 1) requiring reduction by paramedics or 2) diagnosed by a member of the trauma and orthopaedic team.

Who cannot join

Concurrent anterior cruciate ligament or posterior cruciate ligament injury confirmed by negative Lachman's and posterior drawer test or confirmed by Magnetic Resonance Imagery (MRI); medial collateral and lateral collateral ligament injury requiring application of a hinged knee brace or surgical repair; concomitant injury that would prohibit participation in the exercise intervention
> 4 weeks from injury to presentation to acute care (ED or trauma services)
Unable to give written informed consent
Previous surgery on the affected knee
Presence of fracture on plain radiograph including osteochondral fractures
Medial patellar dislocation

Show all 11Show fewer

Considered inappropriate for referral to physiotherapy (by member of trauma and orthopaedic team assessing the patient)
History of severe neuromuscular or congenital disorders
Patients referred for orthopaedic opinion who are subsequently listed for surgery prior to completion of the study intervention
Unable to understand written or spoken English
Unable to attend physiotherapy sessions at the John Radcliffe trauma outpatient physiotherapy department

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

John Radcliffe Hospital
Oxford, OX3 9DU

Other trials in United Kingdom

About this study

Official title: Individualised Exercise for Adults With an Acute Lateral Patellar Dislocation: a Feasibility Study

This study is a feasibility study. It will assess areas of uncertainty relating to the implementation of an individualised exercise programme for patients with a recent kneecap dislocation. This will help determine if a future larger study is feasible, and inform the design and conduct of future research that would aim to optimise outcomes after a kneecap dislocation.

Read the detailed description

The investigators aim to recruit 15 adult participants with a recent, first-time or recurrent kneecap dislocation, from an acute hospital. Participants will receive up to 6 physiotherapy sessions over 3 months. The investigator's exercise programme aims to improve leg muscle strength and facilitate a return to the participant's usual activities. This may include activities such as hopping and changing direction which differentiates it from other programmes. Participants will be required to perform the exercise programme 3 times a week independently. Strategies to increase adherence to the exercise programme will also be used. This study is part of a Masters in Clinical Research funded by the National Institute for Health Research

Conditions: Patella Dislocation, Patella Dislocation Recurrent
Being tested: Individualised exercise
Medical subject headings: Patellar Dislocation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Individualised exerciseOther
The intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used.

Study groups in NCT03798483
Study group	Role	What they receive
Individualized exercise	Experimental	Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist Receives: Other: Individualised exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Eligibility Rate
Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria
Measured: 15 weeks
Recruitment Rate
Percentage of eligible participants who consented to participate in the study
Measured: 15 weeks
Attrition
Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data
Measured: 12 weeks
Acceptability [Participant Satisfaction]: Questionnaire
Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually.
Measured: 12 weeks
Adherence
Percentage (0-100%) of scheduled physiotherapy sessions attended
Measured: 12 weeks
Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale]
Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4)
Measured: 12 weeks

Secondary outcomes (12)

Acceptability of Outcome Data Collection
Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up
Measured: 12 weeks
Number of Treatment Related Adverse Events Experienced by Participants
The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up.
Measured: Through 12 weeks after first physiotherapy session
Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria
Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction
Measured: Baseline
Tegner Activity Scale Questionnaire
This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire.
Measured: 12 weeks
Lyhsolm Knee Scoring Scale Questionnaire
It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire.
Measured: 12 Weeks
Quality of Life Using the EQ-5D-5L Questionnaire
This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire.
Measured: 12 weeks
Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy]
Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention
Measured: From date of injury until date of the first physiotherapy session, assessed up to 6 weeks
Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants]
Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants
Measured: 12 weeks
Assess Delivery of the Intervention [Duration of Intervention]
Treatment logs will be analysed to assess the duration (days) of the study intervention
Measured: 12 weeks
Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists]
Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants
Measured: 12 weeks
Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists]
Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants
Measured: 12 weeks
Assess Delivery of the Intervention [Initial Injury Management]
Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team
Measured: From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 201915 Oct 2019

First posted10 Jan 2019
Study start24 Jan 2019
Primary completion8 Oct 2019
Study completion15 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Patella DislocationStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03798483
Sponsor's protocol ID: MRes/18-19/04/2
Other IDs: 251913
Acronym: INDEX-KD
Status last verified: Dec 2018
First submitted: 11 Dec 2018
Last updated: 1 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Forde C, Haddad M, Hirani SP, Keene DJ. Is an individually tailored programme of intense leg resistance and dynamic exercise acceptable to adults with an acute lateral patellar dislocation? A feasibility study. Pilot Feasibility Stud. 2021 Nov 8;7(1):197. doi: 10.1186/s40814-021-00932-x.
PubMed 34749823

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Blood Flow Restriction Training After Patellar INStability
Patellar Dislocation, Knee Injuries
Not yet recruiting
Comparison Between Medial Patellofemoral Ligament Reconstruction Alone Versus Combined MPFL & Medial Patellotibial Ligament Reconstruction in the Management of Recurrent Lateral Patellar Dislocation in Children
Recurrent Patellar Displacement, MPFL
Recruiting
Effects of Preoperative Rehabilitation on Tendon Healing, Bone Mineral Density, and Cartilage After ACLR and Patellar Dislocation
Anterior Cruciate Ligament Rupture
RecruitingObservational study
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation
Active, not recruiting
Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL)
Patellar Dislocation

All Patella Dislocation trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Individualised Exercise for Adults With an Acute Lateral Patellar Dislocation: a Feasibility Study
ClinicalTrials.gov ID: NCT03798483
Acronym / sponsor ID: INDEX-KD / MRes/18-19/04/2
Conditions: Patella Dislocation, Patella Dislocation Recurrent
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: City, University of LondonUniversity, hospital or other
Collaborators: Oxford University Hospitals NHS Trust
Study start: 24 Jan 2019 (actual)
Primary completion: 8 Oct 2019 (actual)
Study completion: 15 Oct 2019 (actual)
First posted: 10 Jan 2019 (actual)
Results: Posted 1 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Individualized exercise	Experimental	Other: Individualised exerciseParticipants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

First time or recurrent lateral patella dislocation meeting the diagnostic criteria of 1) requiring reduction by paramedics or 2) diagnosed by a member of the trauma and orthopaedic team.

Key exclusion criteria (11 listed)

Concurrent anterior cruciate ligament or posterior cruciate ligament injury confirmed by negative Lachman's and posterior drawer test or confirmed by Magnetic Resonance Imagery (MRI); medial collateral and lateral collateral ligament injury requiring application of a hinged knee brace or surgical repair; concomitant injury that would prohibit participation in the exercise intervention
> 4 weeks from injury to presentation to acute care (ED or trauma services)
Unable to give written informed consent
Previous surgery on the affected knee
Presence of fracture on plain radiograph including osteochondral fractures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Individualised exerciseThe intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used.	Other	Individualized exercise

Primary outcome

Eligibility Rate
Time frame: 15 weeks
Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria
Recruitment Rate
Time frame: 15 weeks
Percentage of eligible participants who consented to participate in the study
Attrition
Time frame: 12 weeks
Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data
Acceptability [Participant Satisfaction]: Questionnaire
Time frame: 12 weeks
Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually.
Adherence
Time frame: 12 weeks
Percentage (0-100%) of scheduled physiotherapy sessions attended
Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale]
Time frame: 12 weeks
Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4)

12 secondary outcomes

Acceptability of Outcome Data Collection
Time frame: 12 weeks
Number of Treatment Related Adverse Events Experienced by Participants
Time frame: Through 12 weeks after first physiotherapy session
Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria
Time frame: Baseline
Tegner Activity Scale Questionnaire
Time frame: 12 weeks
Lyhsolm Knee Scoring Scale Questionnaire
Time frame: 12 Weeks
Quality of Life Using the EQ-5D-5L Questionnaire
Time frame: 12 weeks
Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy]
Time frame: From date of injury until date of the first physiotherapy session, assessed up to 6 weeks
Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants]
Time frame: 12 weeks
Assess Delivery of the Intervention [Duration of Intervention]
Time frame: 12 weeks
Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists]
Time frame: 12 weeks
Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists]
Time frame: 12 weeks
Assess Delivery of the Intervention [Initial Injury Management]
Time frame: From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks

Results and safety

Results posted to the registry on 1 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Individualized Exercise	15	13

Primary outcome: Eligibility Rate

Time frame: 15 weeks. Count of participants. Unit: Participants

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n = 22
Value	15

Population analysed: These were patients with a clinically diagnosed lateral patellar dislocation who underwent an eligibility assessment

Primary outcome: Recruitment Rate

Time frame: 15 weeks. Count of participants. Unit: Participants

Measure	Individualized Exercise n = 15
Value	15

Primary outcome: Attrition

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Individualized Exercise n = 15
Value	2

Primary outcome: Acceptability [Participant Satisfaction]: Questionnaire

Time frame: 12 weeks. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Participants Who Completed and Returned Follow-up Outcome Data n = 11
How satisfied are you with the effect of your physiotherapy treatment?	0 (0 to 0)
How satisfied are you with your involvement in decision making about your physiotherapy treatment?	0 (0 to 0)
How satisfied were you with up to six physiotherapy sessions over three months after your injury?	0 (0 to 0)
How satisfied were you with the written information you were given describing the study?	0 (0 to 0)
How satisfied were you with the written information you were given about your injury?	0 (0 to 1)
How satisfied are you overall with the physiotherapy care you received after your injury?	0 (0 to 0)
How confident are you that you can return to all your normal activities?	0 (0 to 1)
How did doing your exercises fit into your weekly routine?	1 (0 to 2)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: through 3 months after the first physiotherapy session. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Individualized Exercise	0 of 15 (0%)	2 of 15 (13.3%)	0 of 15

Limitations and caveats (from the sponsor): This study was conducted at one centre and the sample size was small. Therefore, further larger-scale feasibility testing is required to determine if a full-scale randomised controlled trial comparing physiotherapy treatments for patients after acute patellar dislocation is viable

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34749823Forde C, Haddad M, Hirani SP, Keene DJ. Is an individually tailored programme of intense leg resistance and dynamic exercise acceptable to adults with an acute lateral patellar dislocation? A feasibility study. Pilot Feasibility Stud. 2021 Nov 8;7(1):197. doi: 10.1186/s40814-021-00932-x.
Individual participant dataSharing planned: Yes

Related trials for Patella Dislocation

Recruiting
Blood Flow Restriction Training After Patellar INStability
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Not yet recruiting
Comparison Between Medial Patellofemoral Ligament Reconstruction Alone Versus Combined MPFL & Medial Patellotibial Ligament Reconstruction in the Management of Recurrent Lateral Patellar Dislocation in Children
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Recruiting
Effects of Preoperative Rehabilitation on Tendon Healing, Bone Mineral Density, and Cartilage After ACLR and Patellar Dislocation
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RecruitingObservational study
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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. This study is not recruiting at the moment.

Mark Haddad, PhD principal investigator

City, University of London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Individualised exercise in people with Patella Dislocation and Patella Dislocation Recurrent, run by City, University of London 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 1 Feb 2021. 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?

Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eligibility Rate (time frame: 15 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03798483, which also lists 1 linked publication.

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 1 Feb 2021.