Patella Dislocation, Patella Dislocation Recurrent
Conditions
Brief summary
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.
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
Interventions
OTHERIndividualised exercise
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.
Sponsors
Oxford University Hospitals NHS Trust
City, University of London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility Rate | 15 weeks | Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria |
| Recruitment Rate | 15 weeks | Percentage of eligible participants who consented to participate in the study |
| Attrition | 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 | 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 | 12 weeks | Percentage (0-100%) of scheduled physiotherapy sessions attended |
| Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy] | From date of injury until date of the first physiotherapy session, assessed up to 6 weeks | Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention |
| Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants] | 12 weeks | Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants |
| Assess Delivery of the Intervention [Duration of Intervention] | 12 weeks | Treatment logs will be analysed to assess the duration (days) of the study intervention |
| Acceptability of Outcome Data Collection | 12 weeks | 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 |
| Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] | 12 weeks | Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants |
| Assess Delivery of the Intervention [Initial Injury Management] | From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team |
| Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | 12 weeks | Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants |
| Number of Treatment Related Adverse Events Experienced by Participants | Through 12 weeks after first physiotherapy session | 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. |
| Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria | Baseline | 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 |
| Tegner Activity Scale Questionnaire | 12 weeks | This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire. |
| Lyhsolm Knee Scoring Scale Questionnaire | 12 Weeks | It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire. |
| Quality of Life Using the EQ-5D-5L Questionnaire | 12 weeks | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Individualized Exercise Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Individualized Exercise |
|---|---|
| Age, Continuous | 22 years |
| Duration from injury to eligibility assessment | 2 days |
| Education Higher professional or University education | 6 Participants |
| Education Secondary education | 9 Participants |
| Employment status Employed | 12 Participants |
| Employment status Student | 3 Participants |
| Family history of patellar dislocation | 1 Participants |
| Height | 1.75 meters |
| Number of previous contralateral patellar dislocations (number of participants) 0 | 12 Participants |
| Number of previous contralateral patellar dislocations (number of participants) 1 | 1 Participants |
| Number of previous contralateral patellar dislocations (number of participants) >10 | 1 Participants |
| Number of previous contralateral patellar dislocations (number of participants) 2 | 1 Participants |
| Number of previous ipsilateral patellar dislocations 0 | 10 Participants |
| Number of previous ipsilateral patellar dislocations 1 | 1 Participants |
| Number of previous ipsilateral patellar dislocations 2 | 1 Participants |
| Number of previous ipsilateral patellar dislocations 3 | 1 Participants |
| Number of previous ipsilateral patellar dislocations 4 | 1 Participants |
| Number of previous ipsilateral patellar dislocations 5-6 | 1 Participants |
| Previous contralateral patellar dislocation | 3 Participants |
| Previous ipsilateral patellar dislocation | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 1 Participants |
| Race/Ethnicity, Customized Ethnicity White British | 13 Participants |
| Race/Ethnicity, Customized Ethnicity White Other | 1 Participants |
| Region of Enrollment United Kingdom | 15 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
| Weight | 69.9 Kilograms |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability [Participant Satisfaction]: Questionnaire | How satisfied are you with the effect of your physiotherapy treatment? | 0 units on a scale |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability [Participant Satisfaction]: Questionnaire | How satisfied are you with your involvement in decision making about your physiotherapy treatment? | 0 units on a scale |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability [Participant Satisfaction]: Questionnaire | How satisfied were you with up to six physiotherapy sessions over three months after your injury? | 0 units on a scale |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability [Participant Satisfaction]: Questionnaire | How satisfied were you with the written information you were given describing the study? | 0 units on a scale |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability [Participant Satisfaction]: Questionnaire | How satisfied were you with the written information you were given about your injury? | 0 units on a scale |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability [Participant Satisfaction]: Questionnaire | How satisfied are you overall with the physiotherapy care you received after your injury? | 0 units on a scale |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability [Participant Satisfaction]: Questionnaire | How confident are you that you can return to all your normal activities? | 0 units on a scale |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability [Participant Satisfaction]: Questionnaire | How did doing your exercises fit into your weekly routine? | 1 units on a scale |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability [Participant Satisfaction]: Questionnaire | How confident are you that you were doing your exercises the way your physiotherapist showed you? | 1 units on a scale |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability [Participant Satisfaction]: Questionnaire | How confident are you that you understood how tiring the muscle strengthening exercises should feel? | 1 units on a scale |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability [Participant Satisfaction]: Questionnaire | How likely are you to continue your exercises now your physiotherapy is finished? | 1 units on a scale |
Primary
Adherence
Percentage (0-100%) of scheduled physiotherapy sessions attended
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Adherence | 56 Scheduled physiotherapy sessions |
Primary
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)
Time frame: 12 weeks
Population: 11/15 participants completed and returned data for this outcome
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] | 'Often' | 5 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] | 'Sometimes' | 2 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] | 'Always' | 4 Participants |
Primary
Attrition
Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Attrition | 2 Participants |
Primary
Eligibility Rate
Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria
Time frame: 15 weeks
Population: These were patients with a clinically diagnosed lateral patellar dislocation who underwent an eligibility assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Eligibility Rate | 15 Participants |
Primary
Recruitment Rate
Percentage of eligible participants who consented to participate in the study
Time frame: 15 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Recruitment Rate | 15 Participants |
Secondary
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
Time frame: 12 weeks
Population: 15 participants completed baseline patient-reported outcome measures and 11 participants completed all patient-reported outcome measures at 3-month follow-up and returned by post. Analysed data refers only to these participants.~Lysholm Knee Scoring Scale outcome data was obtained for 2 participants by phone at 3-month follow-up, so they are not included in analysed data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability of Outcome Data Collection | Baseline Lysholm Knee Scoring Scale | 100 percentage of questions |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability of Outcome Data Collection | Baseline Tegner Activity Scale | 100 percentage of questions |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability of Outcome Data Collection | Baseline EQ-5D-5L | 100 percentage of questions |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability of Outcome Data Collection | Follow-up Tegner Activity Scale | 100 percentage of questions |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability of Outcome Data Collection | Follow-up Lysholm Knee Scoring Scale | 100 percentage of questions |
| Patients With a Diagnosed Lateral Patellar Dislocation | Acceptability of Outcome Data Collection | Follow-up EQ-5D-5L | 100 percentage of questions |
Secondary
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
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] | Prescribed sets between 1-3 | 90 Prescribed leg resistance exercise |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] | Prescribed repetitions between 8-12 | 89 Prescribed leg resistance exercise |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] | Prescribed frequency 3 or more per week | 91 Prescribed leg resistance exercise |
Secondary
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
Time frame: From date of injury until date of the first physiotherapy session, assessed up to 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy] | 21 Days |
Secondary
Assess Delivery of the Intervention [Duration of Intervention]
Treatment logs will be analysed to assess the duration (days) of the study intervention
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Duration of Intervention] | 50 Days |
Secondary
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
Time frame: From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Initial Injury Management] | Lateral butress splint | 12 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Initial Injury Management] | Cricket pad splint | 2 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Initial Injury Management] | Hinged knee brace | 1 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Initial Injury Management] | Full weight-bearing | 15 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Initial Injury Management] | Two elbow crutches | 7 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Initial Injury Management] | No walking aids | 8 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Initial Injury Management] | Knee range of movement exercises | 7 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Initial Injury Management] | Non-weight bearing knee strengthening exercise | 4 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Initial Injury Management] | Gait practice, balance exercises | 2 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Initial Injury Management] | Weight-bearing knee strengthening, strengthening of unijured joints | 1 Participants |
Secondary
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
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants] | 3 physiotherapy sessions |
Secondary
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
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Knee flexibility exercise | 13 participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Leg resistance exercise | 15 participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Trunk and leg control exercise | 14 participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Running exercise | 5 participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Bespoke exercise | 5 participants |
Secondary
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.
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Lyhsolm Knee Scoring Scale Questionnaire | 90 units on a scale |
Secondary
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.
Time frame: Through 12 weeks after first physiotherapy session
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Number of Treatment Related Adverse Events Experienced by Participants | knee pain or swelling after completing prescribed exercises that lasted >1 week | 1 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Number of Treatment Related Adverse Events Experienced by Participants | Recurrent patella dislocation | 1 Participants |
| Patients With a Diagnosed Lateral Patellar Dislocation | Number of Treatment Related Adverse Events Experienced by Participants | No treatment related adverse event | 13 Participants |
Secondary
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
Time frame: Baseline
Population: 15 participants were assessed for all the clinical findings below, except for the patella apprehension test which was only assessed in 13 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria | Medial patellofemoral ligament tenderness | 100 percentage |
| Patients With a Diagnosed Lateral Patellar Dislocation | Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria | convincing history of a lateral patellar dislocation | 93.3 percentage |
| Patients With a Diagnosed Lateral Patellar Dislocation | Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria | visible knee joint effusion or haemarthrosis | 66.7 percentage |
| Patients With a Diagnosed Lateral Patellar Dislocation | Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria | positive patella apprehension test, | 100 percentage |
Secondary
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Quality of Life Using the EQ-5D-5L Questionnaire | Index score | 0.84 units on a scale |
| Patients With a Diagnosed Lateral Patellar Dislocation | Quality of Life Using the EQ-5D-5L Questionnaire | Health on a Visual Analogue Scale | 90 units on a scale |
Secondary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With a Diagnosed Lateral Patellar Dislocation | Tegner Activity Scale Questionnaire | 6 units on a scale |