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Trial registered on ANZCTR


Registration number
ACTRN12616001081404
Ethics application status
Approved
Date submitted
27/07/2016
Date registered
11/08/2016
Date last updated
22/11/2019
Date data sharing statement initially provided
10/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Study on the Maxm Skate: A Lower Limb Rehabilitation Device for use following Total Knee Arthroplasty.
Scientific title
A Randomised Controlled Study on the Maxm Skate: A Lower Limb Rehabilitation Device for use following Total Knee Arthroplasty.
Secondary ID [1] 288925 0
Nil known
Universal Trial Number (UTN)
U1111-1181-5620
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 298261 0
Degenerative Joint Disease 298262 0
Range of Motion 298263 0
Condition category
Condition code
Musculoskeletal 298405 298405 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 299633 299633 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Maxm skate is a portable, lower limb post-operative and post-injury rehabilitation exercise device for individual use in a hospital or home-based setting.

The Maxm Skate package is comprised of the Skate device and rope (for resistance training), sensors, iOS Application (App) and website. The Skate device is accompanied by two sensors and a mobile App which are designed to provide real time, objective data on exercise and rehabilitation progress, in particular ROM achieved, following an exercise therapy session at home. This sensor technology also enables the clinician to gather accurate compliance and ROM data (Flexion and Extension) remotely.

Participants will attend a pre-operative device education session where they will be introduced to the Maxm Skate by the physiotherapist. Participants will be given a description of the functionality, set up and safe usage of the Maxm Skate and will be given the opportunity to trial the skate. Participants will be educated on the Maxm Skate exercise program and issued an exercise booklet to familiarize themselves with the post-operative exercise program. The Maxm Skate exercise program can be found on the following website: http://www.maxmskate.com.au/

The Maxm Skate rehabilitation device is intended to be used up to 3 months post-surgery, however can be used for a longer duration if felt of benefit. In the inpatient acute setting the Maxm Skate group will receive the Maxm Skate in addition to standard care.

Compliance with the Maxm Skate rehabilitation program will be measured using the Compliance with Rehabilitation Program Form, which collects data on number and duration of Maxm skate sessions, as well as whether additional physiotherapy has been sought.
Intervention code [1] 294391 0
Rehabilitation
Intervention code [2] 295462 0
Treatment: Devices
Comparator / control treatment
Patients undergoing total knee arthroplasty (TKA) at Flinders Private Hospital (FPH) are issued an exercise booklet describing the postoperative exercises.

Physiotherapy (PT) follow-up following discharge varies on an individual basis. The patient is provided four patient-specific options once discharged from hospital. These options include:

1. Home with Outpatient Physiotherapy (OPPT)
OPPT usually involves 1 to 2 sessions per week for 6 weeks plus. Hydrotherapy may be employed at 1 to 2 sessions per week depending on individual need.

2. Home with Home Visit Package
The Home Visit package includes 2 to 6 weeks of PT visits in the home, usually twice a week. Hydrotherapy may be used as required.

3. Inpatient Rehabilitation
Inpatient Rehabilitation includes 5 days to 3 weeks rehabilitation in an inpatient setting and hydrotherapy.

4. Day Rehabilitation
Day Rehabilitation includes 2 to 3 half day rehabilitation sessions per week, for 2 to 6 weeks in addition to hydrotherapy.
Control group
Active

Outcomes
Primary outcome [1] 297883 0
The primary outcome of this randomised controlled study is to assess the range of motion (ROM) achieved by patients whom received the Maxm Skate rehabilitation device compared with standard care, 3 months postoperatively.

In a seated position, knee joint ROM in flexion and extension will be measured using a standard goniometer.
Timepoint [1] 297883 0
3 months post Total Knee Arthroplasty (TKA)
Secondary outcome [1] 322515 0
An economic evaluation assessing the relative cost effectiveness of the Maxm Skate rehabilitation device compared to standard care will be conducted.

This will be assessed by the incremental cost per unit increase in knee ROM between the 2 groups. The incremental cost per quality adjusted life year (QALY) gained over the period of the primary study and based on the EQ-5D-5L will also be assessed.
Timepoint [1] 322515 0
3 months Post TKA.
Secondary outcome [2] 322516 0
Patients will be screened for adverse event occurrences and complications from the time of consent to 1 year postoperatively.

A possible adverse event may include falls if the participant disregards explicit instruction to not stand on the Maxm Skate device. Reasoning behind misuse or other causes that led to the fall will be assessed.
Timepoint [2] 322516 0
Recruitment to Study completion
Secondary outcome [3] 326143 0
Pain at end of range flexion and extension will be measured using a Visual Analogue Scale (VAS).
Timepoint [3] 326143 0
Secondary outcomes will be compared between the Maxm Skate and Standard care groups preoperatively and at 2, 4, 6, 12, 26 and 52 weeks post TKA. This measure will also be assessed at Day 2 postoperatively.
Secondary outcome [4] 326144 0
Isometric Knee Extensor and Flexor Strength will be measured using the MicroFET 2 Handheld Dynamometer. This will be performed in a seated position, on a box seat design with the backrest at 60 degrees and a leg ramp fixed at 45 degrees.
Timepoint [4] 326144 0
Secondary outcomes will be compared between the Maxm Skate and Standard care groups preoperatively and at 2, 4, 6, 12, 26 and 52 weeks post TKA.
Secondary outcome [5] 326147 0
Balance will be tested by performing a single leg stand with eyes open. The ability to maintain balance in this position is recorded in seconds.
Timepoint [5] 326147 0
Secondary outcomes will be compared between the Maxm Skate and Standard care groups preoperatively and at 2, 4, 6, 12, 26 and 52 weeks post TKA.
Secondary outcome [6] 326148 0
Patient’s knee and thigh circumference will measured using a regular tape measure. This will be measured at 2 points:
1. The superior pole of the patella
2. 15cm above the superior pole of the patella
Timepoint [6] 326148 0
Secondary outcomes will be compared between the Maxm Skate and Standard care groups preoperatively and at 2, 4, 6, 12, 26 and 52 weeks post TKA. This measure will also be assessed at Day 2 postoperatively.
Secondary outcome [7] 326149 0
Clinical performance will be assessed using the 30s Chair-stand test and the 4 x 10 m Fast Paced Walk Test.
Timepoint [7] 326149 0
Clinical performance tests for each group will be conducted preoperatively and at 2, 4, 6 and 12 weeks, 6 and 12 months postoperatively:
Secondary outcome [8] 326150 0
Pain relief, functional abilities, satisfaction and fulfilment of expectations will be assessed using the Knee Society Score
Timepoint [8] 326150 0
Clinical and patient reported outcomes measured will be assessed for each group preoperatively and postoperatively at 6 weeks, 12 weeks and 12 months.
Secondary outcome [9] 326153 0
Knee pain and function will be assessed using the Oxford Knee Score.
Timepoint [9] 326153 0
Clinical and patient reported outcomes measured will be assessed for each group preoperatively and postoperatively at 6 weeks, 12 weeks and 12 months.
Secondary outcome [10] 326154 0
Quality of life will be assessed using the EQ-5D (Level 5) measure.
Timepoint [10] 326154 0
Clinical and patient reported outcomes measured will be assessed for each group preoperatively and postoperatively at 6 weeks, 12 weeks and 12 months.
Secondary outcome [11] 326155 0
The patient’s opinion of their knee and any other associated problems will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Timepoint [11] 326155 0
Clinical and patient reported outcomes measured will be assessed for each group preoperatively and postoperatively at 6 weeks, 12 weeks and 12 months.
Secondary outcome [12] 326156 0
The participants state will be assessed using the Patient Acceptable Symptom State (PASS).
Timepoint [12] 326156 0
Clinical and patient reported outcomes measured will be assessed for each group preoperatively and postoperatively at 6 weeks, 12 weeks and 12 months.
Secondary outcome [13] 326157 0
Satisfaction with rehabilitation will be measured on a 5-point Likert scale ranging from ‘very unsatisfied’, ‘unsatisfied’, ‘neither satisfied nor unsatisfied’, satisfied, very satisfied.
Timepoint [13] 326157 0
Clinical and patient reported outcomes measured will be assessed for each group preoperatively and postoperatively at 6 weeks, 12 weeks and 12 months.

Eligibility
Key inclusion criteria
1. The patient received a primary total knee arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis and traumatic arthritis) or inflammatory joint disease (e.g. Rheumatoid Arthritis).

2. The patient must understand the conditions of the study and be willing and able to provide written informed consent.

3. The patient is a skeletally mature male or a non-pregnant female, 30 years of age or older.

4. The patient agrees to comply with the specified preoperative and postoperative study requirements.

Patients will be consented for participation prior to TKA.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient has an emotional or neurological condition that would pre-empt their ability to participate in the study including mental illness, intellectual disability and drug or alcohol abuse.

2. Any patient who is unable to meet the requirements of the use of the Maxm Skate Rehabilitation Device:
- Patient is unable to perform home exercise program without supervision or assistance.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated in 1:1 ratio to control or intervention group. Block randomisation will be used to make sure two groups are balanced in numbers throughout the study period.

Randomisation Procedure:
1. The statistician will create a randomisation scheduling to ensure equal numbers in both groups.
2. An independent person not otherwise involved in the study will place the allocation in numbered and sealed, opaque envelopes.
3. The orthopaedic surgeon, Dr Liptak will screen the patients that present in his clinic for eligibility and record the screening date.
4. The study coordinator will consent and allocate study randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
This study is designed as a single blinded study. A trained blinded physiotherapist will conduct all functional evaluations and performance tests for all preoperative and postoperative time points, excluding Day 2 postoperatively.

However, due to the nature of the intervention there is a potential for participants to disclose, or physiotherapist to gauge, which group the participants are assigned. Participants will be educated and instructed not to advise the physiotherapist of their group assignment. However, in the event that the blinding is broken, this will be reported in the data collected and reviewed during data analysis.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis Plan

All analyses will be conducted on an intention to treat basis, and results reported in accordance with CONSORT guidelines (1). Missing data will be imputed using multiple imputation, with 20 resamples drawn. The primary endpoint is the ROM at 3 months and differences between groups will be assessed using an independent two-sample t-test. Baseline characteristics, including ROM will not be accounted for in the primary analysis. Normality of the ROM will be verified in each group. If necessary, then the primary outcome will be transformed if possible to meet normality conditions. Otherwise, the non-parametric Wilcoxon Ranksum test will be used. Sensitivity analyses such as per protocol and regression analyses that adjust for baseline variables will be conducted to corroborate the robustness of the primary result. The Wilcoxon Ranksum test will be used to analyse differences between groups for the clinical performance tests (30s Chair-stand and 4 x 10m Fast Paced Walk Test) as non-ignorable missing values are anticipated. Differences between groups for data collected on scales KSS, OKS, etc. will be assessed using a two sample t-test or Wilcoxon Ranksum test as appropriate. A two-sided p-value at the 0.05 level will be deemed to be statistically significant.

Statistical Considerations and Sample Size

The sample size was calculated on the equivalent parameters described by Mockford et al, (2) in which the effect of a physiotherapy regime on range of motion (ROM) was measured over a 1 year follow-up period following TKA. Patients were randomised into either the physiotherapy group or control (no outpatient physiotherapy).

Clinically significant difference in the ROM between the Maxm Skate rehabilitation device and standard care is considered to be 10 degrees (with SD of 16 degrees) at 3 months postoperatively.

110 patients (55 patients in each group) would enable us to detect 10 degrees (with SD of 16 degrees) difference in ROM between two devices with 90% power at 5% significance level using the power calculation for two-tailed t-test.

The sample size target will account for a 5.0% potential loss-to-follow-up. Therefore for this randomised controlled study a total of 116 patients will be recruited as follows:

- Standard Care Group: 58 Participants
- Maxm Skate Rehabilitation Group: 58 Participants

References

(1) Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.

(2) Mockford BJ, Thompson NW, Humphreys P, Beverland DE. Does a standard outpatient physiotherapy regime improve the range of knee motion after primary total knee arthroplasty? The Journal of arthroplasty. 2008 Dec;23(8):1110-4.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/08/2018
Actual
18/10/2018
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
116
Accrual to date
54
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15283 0
Flinders Private Hospital - Bedford Park
Recruitment postcode(s) [1] 13020 0
5052 - Belair
Recruitment postcode(s) [2] 28593 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 294178 0
Hospital
Name [1] 294178 0
Adelaide Community Healthcare Alliance Incorporated (ACHA)
Country [1] 294178 0
Australia
Funding source category [2] 294267 0
Commercial sector/Industry
Name [2] 294267 0
Maxm Skate Pty Ltd. and
Country [2] 294267 0
Australia
Primary sponsor type
Individual
Name
Professor Jeganath Krishnan
Address
Professor Jegan Krishnan
13 Laffers Rd,
Belair, SA 5052
Country
Australia
Secondary sponsor category [1] 292325 0
Other Collaborative groups
Name [1] 292325 0
The International Musculoskeletal Research Institute Incorporated
Address [1] 292325 0
The International Musculoskeletal Research Institute Incorporated
13 Laffers Road,
Belair, SA 5052
Country [1] 292325 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294753 0
Bellberry Limited
Ethics committee address [1] 294753 0
Ethics committee country [1] 294753 0
Australia
Date submitted for ethics approval [1] 294753 0
22/03/2016
Approval date [1] 294753 0
24/09/2018
Ethics approval number [1] 294753 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64930 0
Prof Jeganath Krishnan
Address 64930 0
Professor Jegan Krishnan
13 Laffers Road,
BELAIR SA 5052
Country 64930 0
Australia
Phone 64930 0
+618 8267 8233
Fax 64930 0
+618 8278 2172
Email 64930 0
krishnanadmin@sahi.org.au
Contact person for public queries
Name 64931 0
Kristen Georgiou
Address 64931 0
The International Musculoskeletal Research Institute Inc.
13 Laffers Road, BELAIR SA 5052
Country 64931 0
Australia
Phone 64931 0
+618 7231 8452
Fax 64931 0
Email 64931 0
kristen.georgiou@imri.org.au
Contact person for scientific queries
Name 64932 0
Kristen Georgiou
Address 64932 0
The International Musculoskeletal Research Institute Inc.
13 Laffers Road,
BELAIR SA 5052
Country 64932 0
Australia
Phone 64932 0
+618 7231 8452
Fax 64932 0
Email 64932 0
kristen.georgiou@imri.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will only be available to participants upon request


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
991Study protocolTrials. 2019; 20: 36. Published online 2019 Jan 10. doi: 10.1186/s13063-018-3102-9 The safety, efficacy and cost-effectiveness of the Maxm Skate, a lower limb rehabilitation device for use following total knee arthroplasty: study protocol for a randomised controlled trial Matthew G. Liptak,corresponding author1 Annika Theodoulou,2,3,4 Billingsley Kaambwa,5 Steve Saunders,6 Scott W. Hinrichs,7 Richard J. Woodman,8 and Jeganath Krishnan2,3https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6329189/pdf/13063_2018_Article_3102.pdf  Now published, see above details.



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe safety, efficacy and cost-effectiveness of the Maxm Skate, a lower limb rehabilitation device for use following total knee arthroplasty: Study protocol for a randomised controlled trial.2019https://dx.doi.org/10.1186/s13063-018-3102-9
N.B. These documents automatically identified may not have been verified by the study sponsor.