Trial Outcomes & Findings for INDividualised EXercise for Kneecap Dislocations (NCT NCT03798483)

NCT ID: NCT03798483

Last Updated: 2021-02-01

Results Overview

Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 15 weeks
• Results posted on: 2021-02-01

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	15
Overall Study Returned All Follow-up Outcome Data	11
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

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.

Overall Study Lost to Follow-up

2

Baseline Characteristics

INDividualised EXercise for Kneecap Dislocations

Baseline characteristics by cohort

Measure	Individualized Exercise n=15 Participants 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.
Age, Continuous	22 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White British	13 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other	1 Participants n=5 Participants
Region of Enrollment United Kingdom	15 participants n=5 Participants
Height	1.75 meters n=5 Participants
Weight	69.9 Kilograms n=5 Participants
Education Secondary education	9 Participants n=5 Participants
Education Higher professional or University education	6 Participants n=5 Participants
Employment status Employed	12 Participants n=5 Participants
Employment status Student	3 Participants n=5 Participants
Duration from injury to eligibility assessment	2 days n=5 Participants
Previous ipsilateral patellar dislocation	5 Participants n=5 Participants
Number of previous ipsilateral patellar dislocations 0	10 Participants n=5 Participants
Number of previous ipsilateral patellar dislocations 1	1 Participants n=5 Participants
Number of previous ipsilateral patellar dislocations 2	1 Participants n=5 Participants
Number of previous ipsilateral patellar dislocations 3	1 Participants n=5 Participants
Number of previous ipsilateral patellar dislocations 4	1 Participants n=5 Participants
Number of previous ipsilateral patellar dislocations 5-6	1 Participants n=5 Participants
Previous contralateral patellar dislocation	3 Participants n=5 Participants
Number of previous contralateral patellar dislocations (number of participants) 0	12 Participants n=5 Participants
Number of previous contralateral patellar dislocations (number of participants) 1	1 Participants n=5 Participants
Number of previous contralateral patellar dislocations (number of participants) 2	1 Participants n=5 Participants
Number of previous contralateral patellar dislocations (number of participants) >10	1 Participants n=5 Participants
Family history of patellar dislocation	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 weeks

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

Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=22 Participants Patients with a clinically diagnosed lateral patellar dislocation
Eligibility Rate	15 Participants

PRIMARY outcome

Timeframe: 15 weeks

Percentage of eligible participants who consented to participate in the study

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=15 Participants Patients with a clinically diagnosed lateral patellar dislocation
Recruitment Rate	15 Participants

PRIMARY outcome

Timeframe: 12 weeks

Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=15 Participants Patients with a clinically diagnosed lateral patellar dislocation
Attrition	2 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=11 Participants Patients with a clinically 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 Interval 0.0 to 1.0
Acceptability [Participant Satisfaction]: Questionnaire How confident are you that you understood how tiring the muscle strengthening exercises should feel?	1 units on a scale Interval 0.0 to 1.0
Acceptability [Participant Satisfaction]: Questionnaire How did doing your exercises fit into your weekly routine?	1 units on a scale Interval 0.0 to 2.0
Acceptability [Participant Satisfaction]: Questionnaire How likely are you to continue your exercises now your physiotherapy is finished?	1 units on a scale Interval 0.0 to 1.0
Acceptability [Participant Satisfaction]: Questionnaire How satisfied are you with the effect of your physiotherapy treatment?	0 units on a scale Interval 0.0 to 0.0
Acceptability [Participant Satisfaction]: Questionnaire How satisfied are you with your involvement in decision making about your physiotherapy treatment?	0 units on a scale Interval 0.0 to 0.0
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 Interval 0.0 to 0.0
Acceptability [Participant Satisfaction]: Questionnaire How satisfied were you with the written information you were given describing the study?	0 units on a scale Interval 0.0 to 0.0
Acceptability [Participant Satisfaction]: Questionnaire How satisfied were you with the written information you were given about your injury?	0 units on a scale Interval 0.0 to 1.0
Acceptability [Participant Satisfaction]: Questionnaire How satisfied are you overall with the physiotherapy care you received after your injury?	0 units on a scale Interval 0.0 to 0.0
Acceptability [Participant Satisfaction]: Questionnaire How confident are you that you can return to all your normal activities?	0 units on a scale Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: 12 weeks

Percentage (0-100%) of scheduled physiotherapy sessions attended

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=66 Scheduled physiotherapy sessions Patients with a clinically diagnosed lateral patellar dislocation
Adherence	56 Scheduled physiotherapy sessions

PRIMARY outcome

Timeframe: 12 weeks

Population: 11/15 participants completed and returned data for this outcome

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)

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=11 Participants Patients with a clinically diagnosed lateral patellar dislocation
Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] 'Always'	4 Participants
Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] 'Often'	5 Participants
Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] 'Sometimes'	2 Participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=15 Participants Patients with a clinically diagnosed lateral patellar dislocation
Acceptability of Outcome Data Collection Follow-up EQ-5D-5L	100 percentage of questions
Acceptability of Outcome Data Collection Baseline Lysholm Knee Scoring Scale	100 percentage of questions
Acceptability of Outcome Data Collection Baseline Tegner Activity Scale	100 percentage of questions
Acceptability of Outcome Data Collection Baseline EQ-5D-5L	100 percentage of questions
Acceptability of Outcome Data Collection Follow-up Lysholm Knee Scoring Scale	100 percentage of questions
Acceptability of Outcome Data Collection Follow-up Tegner Activity Scale	100 percentage of questions

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=15 Participants Patients with a clinically 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
Number of Treatment Related Adverse Events Experienced by Participants Recurrent patella dislocation	1 Participants
Number of Treatment Related Adverse Events Experienced by Participants No treatment related adverse event	13 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=15 Participants Patients with a clinically diagnosed lateral patellar dislocation
Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria visible knee joint effusion or haemarthrosis	66.7 percentage
Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria Medial patellofemoral ligament tenderness	100 percentage
Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria convincing history of a lateral patellar dislocation	93.3 percentage
Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria positive patella apprehension test,	100 percentage

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=11 Participants Patients with a clinically diagnosed lateral patellar dislocation
Tegner Activity Scale Questionnaire	6 units on a scale Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=13 Participants Patients with a clinically diagnosed lateral patellar dislocation
Lyhsolm Knee Scoring Scale Questionnaire	90 units on a scale Interval 76.5 to 95.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=11 Participants Patients with a clinically diagnosed lateral patellar dislocation
Quality of Life Using the EQ-5D-5L Questionnaire Index score	0.84 units on a scale Interval 0.8 to 1.0
Quality of Life Using the EQ-5D-5L Questionnaire Health on a Visual Analogue Scale	90 units on a scale Interval 85.0 to 95.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=15 Participants Patients with a clinically diagnosed lateral patellar dislocation
Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy]	21 Days Interval 15.0 to 27.0

SECONDARY outcome

Timeframe: 12 weeks

Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=15 Participants Patients with a clinically diagnosed lateral patellar dislocation
Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants]	3 physiotherapy sessions Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: 12 weeks

Treatment logs will be analysed to assess the duration (days) of the study intervention

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=15 Participants Patients with a clinically diagnosed lateral patellar dislocation
Assess Delivery of the Intervention [Duration of Intervention]	50 Days Interval 37.0 to 79.0

SECONDARY outcome

Timeframe: 12 weeks

Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=15 Participants Patients with a clinically diagnosed lateral patellar dislocation
Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Knee flexibility exercise	13 participants
Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Trunk and leg control exercise	14 participants
Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Leg resistance exercise	15 participants
Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Running exercise	5 participants
Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Bespoke exercise	5 participants

SECONDARY outcome

Timeframe: 12 weeks

Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=93 Prescribed leg resistance exercise Patients with a clinically 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
Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] Prescribed repetitions between 8-12	89 Prescribed leg resistance exercise
Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] Prescribed frequency 3 or more per week	91 Prescribed leg resistance exercise

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Patients With a Diagnosed Lateral Patellar Dislocation n=15 Participants Patients with a clinically diagnosed lateral patellar dislocation
Assess Delivery of the Intervention [Initial Injury Management] Lateral butress splint	12 Participants
Assess Delivery of the Intervention [Initial Injury Management] Cricket pad splint	2 Participants
Assess Delivery of the Intervention [Initial Injury Management] Hinged knee brace	1 Participants
Assess Delivery of the Intervention [Initial Injury Management] Full weight-bearing	15 Participants
Assess Delivery of the Intervention [Initial Injury Management] Two elbow crutches	7 Participants
Assess Delivery of the Intervention [Initial Injury Management] No walking aids	8 Participants
Assess Delivery of the Intervention [Initial Injury Management] Knee range of movement exercises	7 Participants
Assess Delivery of the Intervention [Initial Injury Management] Non-weight bearing knee strengthening exercise	4 Participants
Assess Delivery of the Intervention [Initial Injury Management] Gait practice, balance exercises	2 Participants
Assess Delivery of the Intervention [Initial Injury Management] Weight-bearing knee strengthening, strengthening of unijured joints	1 Participants

Adverse Events

Individualized Exercise

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Individualized Exercise n=15 participants at risk 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.
Musculoskeletal and connective tissue disorders Knee pain or swelling after completing prescribed exercise that last >1 week	6.7% 1/15 • Number of events 3 • through 3 months after the first physiotherapy session
Musculoskeletal and connective tissue disorders Recurrent patellar dislocation	6.7% 1/15 • Number of events 1 • through 3 months after the first physiotherapy session

Additional Information

Colin Forde

Oxford University hospital foundation trust

Phone: +441865221540

Email: Colin.Forde@ouh.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place