Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001203448
Ethics application status
Approved
Date submitted
29/07/2016
Date registered
31/08/2016
Date last updated
20/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation into the Influence of Patient Ambulation and Components Alignment on Medium -Term Patient Outcomes after Total Knee Arthroplasty
Scientific title
Investigation into the Influence of Patient Ambulation and Components Alignment on Medium -Term Patient Outcomes after Total Knee Arthroplasty
Secondary ID [1] 289791 0
None
Universal Trial Number (UTN)
U1111-1185-7523
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 299689 0
Osteoarthritis 299690 0
Condition category
Condition code
Musculoskeletal 299626 299626 0 0
Osteoarthritis
Surgery 299663 299663 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients participating in this study will be undergoing total knee replacement and receiving the Apex Total Knee Replacement
A wrist-worn activity tracker device that counts steps and monitors activity over time will be used to measure activity pre and post knee replacement surgery. X-rays and CT will be used to assess implant positioning.
Each participant will be asked to wear the Vivofit device on their wrist from about 5 weeks before your surgery to 6 weeks afterwards. Ten (10) months after surgery, each participant will be contacted again and another Vivofit device will be sent to them to wear for 1 month prior to their 1-year postoperative assessment by their surgeon.
The participant will place the wristband on as soon as they receive it. It should be worn 24 hours a day. It is waterproof so they can swim and shower normally. The internal battery will last for 12 months and after this time the participant will remove the wrist band, record the dates it was worn on the small envelope and return it to to the investigator using the self-addressed post-paid envelope provided.
Before the operation, the affected knee will be assessed by x-ray and computed tomography (CT) scans in accordance with the study protocol. Each participant will also be asked to complete some simple questionnaires (Knee Injury and Osteoarthritis Score, Forgotten Joint Score, Oxford Knee Score and VAS scale) to find out how the condition of their knee affects their life before the operation and after the operation: at 6 weeks and 12 months. Each questionnaire will take only a few minutes to complete.
Intervention code [1] 295459 0
Not applicable
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299095 0
Change in ambulation (daily step count) from pre-total knee replacement (TKR) to post TKR
The Activity monitor will be worn continuously from 2 weeks pre-surgery to 6 weeks post surgery, and for one month 12 months post surgery
Timepoint [1] 299095 0
12 months post surgery. The Activity monitor will be worn continuously from 2 week s pre-surgery to 6 weeks post surgery, and for one month 12 months post surgery.
Primary outcome [2] 299096 0
This is a composite primary outcome. Change in patient reported outcomes after total knee arthroplasty (TKA) as measured by Knee injury and Osteoarthritis Outcome Score (KOOS) and Oxford Knee Score, forgotten knee score and VAS satisfaction scale
Timepoint [2] 299096 0
12 months post surgery
Primary outcome [3] 299267 0
Component alignment measured using X-ray
Timepoint [3] 299267 0
12 months post surgery
Secondary outcome [1] 326695 0
This is a composite outcome, Change in patient reported outcomes after total knee arthroplasty (TKA) as measured by Knee injury and Osteoarthritis Outcome Score (KOOS) and Oxford Knee Score, forgotten knee score and VAS satisfaction scale
Timepoint [1] 326695 0
6 weeks post surgery
Secondary outcome [2] 326696 0
Component alignment measured using CT
Timepoint [2] 326696 0
6 weeks post surgery
Secondary outcome [3] 326859 0
Length of Hospital Stay
Timepoint [3] 326859 0
Hospital Discharge
Secondary outcome [4] 326860 0
Return to work: Record work status and date of return to work.
Timepoint [4] 326860 0
12 months.

Eligibility
Key inclusion criteria
1. Patients with symptomatic osteoarthritis who are candidates for a primary total knee replacement with cemented tibial tray as determined jointly by the surgeon and the patient.
2. Over 18 years of age at time of surgery
3. Patients requiring an isolated single joint TKR
4. Patients living in Perth metropolitan area for logistics of follow-up
5. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.
6. Patient will receive a Apex Total Knee Replacement.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with rheumatoid arthritis
2. Medical or social conditions that may affect the patient’s ability to participate in the study or give informed consent
3. Severe hip or contralateral knee osteoarthritis that affects the patients ability to ambulate
4. Deformity of the femur or tibia

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As there are no comparators in the primary variable a sample size calculation has been done on the basis of binarisation of the patient group into those in the upper half and lower half of preoperative step count. The KOOS score was selected as an appropriate PROMS measures to determine the sample size from as it has values for the minimum clinically important difference (MCID) of 10 and a standard deviation of 15 already established. [Roos, E. M. and L. S. Lohmander (2003). "Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis." Health Qual Life Outcomes 1: 64.] Using a significance level (alpha) of 0.05 and a beta of 0.20, 72 total samples would be required to detect a minimum clinically important difference between the two subgroups formed.
As the introduction of activity monitoring devices presents an additional risk of data loss to follow up due to misplacement, theft or damage to the devices, losses to follow up are estimated at about 10%, yielding a total enrolment number of 80 patients. Hence, the study will enrol a minimum of 80 patients between three surgeons at one centre. Each participant will receive the Apex Total Knee Replacement system. The aim is to have 72 patients at the end of the study.
All patients receiving an Apex Total Knee Replacement will be invited to participate in this study.
Statistical analysis will be performed using R for Windows software. All data will be assumed to be non-parametric. Statistical significance will be set at p=0.05. Comparison of variables over time will be analysed with Wilcoxon Signed-Rank Test. Comparison of variables between groups will be analysed with Mann Whitney U tests. Linear variables will be summarised by the mean and 95% confidence interval. Categorical variables will be summarised by frequency.
Data monitoring will be reviewed and entered into a clinical database. Export of primary and secondary variable data will be made for the calculation of the indicated t-statistics, their related p-values, and graphical summaries.
Analysis will be performed on an intention-to-treat basis and a per protocol basis for the primary and secondary endpoints. Patients missing the measure of the primary end point will be considered missing in the intent to treat analysis; no inputting of missing data will be conducted for any variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2017
Actual
7/09/2017
Date of last participant enrolment
Anticipated
1/05/2018
Actual
Date of last data collection
Anticipated
1/05/2019
Actual
Sample size
Target
80
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6310 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 13847 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 294173 0
Commercial sector/Industry
Name [1] 294173 0
Kico Knee Innovation Pty Ltd
Country [1] 294173 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Kico Knee Innovation Pty Ltd
Address
Suite 3, Building 1/20 Bridge Street, Pymble, NSW 2073
Country
Australia
Secondary sponsor category [1] 293003 0
Commercial sector/Industry
Name [1] 293003 0
Global Orthopaedic Technology
Address [1] 293003 0
Unit 10, 7 Meridian Place, Bella Vista, NSW 2153
Country [1] 293003 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295579 0
South Metropolitan Health Service HREC (EC00265)
Ethics committee address [1] 295579 0
Government of Western Australia, Department of Health,
South Metropolitan Health Service,
Locked bag 100,
Palyra DC WA 6961
Ethics committee country [1] 295579 0
Australia
Date submitted for ethics approval [1] 295579 0
01/06/2016
Approval date [1] 295579 0
12/07/2016
Ethics approval number [1] 295579 0
2016-123

Summary
Brief summary
Study design: Prospective, single-centre, patient-blinded, non-randomised, clinical study. The study will enrol 80 patients over a 12-month recruitment period between three surgeons.
Objectives: To determine the relationship between ambulation (daily step count) preoperatively/post-operatively and patient reported outcomes after total knee arthroplasty (TKA). To investigate if component alignment affects ambulation and clinical outcomes after TKA. To investigate if post-op ambulation after total knee replacement affects other parameters such as return to work and patient satisfaction. The study will also demonstrate safety, and equivalent clinical outcomes on pain and function to other published data.
Group: Apex Total Knee Replacement (single study group)
Number of subjects to be enrolled: 80 patients will be enrolled into this study.
Medical Devices: The Apex Knee is intended for use as a primary total knee replacement device consisting of a femoral, tibial, tibial bearing and optional patellar component. The Vivofit is an activity tracker, a wrist-worn band that counts steps and monitors active time.
Regulatory status: The Apex Knee is CE marked, TGA approved and has a rebate code on the Prostheses List.
Clinical evaluations: Standard, functional parameters will be assessed pre-operatively, and post-operatively at 6 weeks, and 12 months.
Patient outcome assessments: The Oxford Knee Score, The Knee Injury and Osteoarthritis Score (KOOS), Forgotten Joint Score and VAS satisfaction scale will be assessed pre-operatively, and post-operatively at 6 weeks, and 12 months.
Radiographic evaluations:
X-Rays will be assessed pre-operatively, post-operatively and at 12 months to evaluate femoral and tibial components coronal and saggital orientation.
A CT-Scan will be performed preoperatively and at 6 weeks post-operatively to verify implant positioning axially.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67734 0
Dr Omar Khorshid
Address 67734 0
Fremantle Hospital
Orthopaedics Department
Alma St.
Fremantle WA 6160
Country 67734 0
Australia
Phone 67734 0
+61 8 9431 2556
Fax 67734 0
Email 67734 0
[email protected]
Contact person for public queries
Name 67735 0
Mr Lyndon Crossley
Address 67735 0
Director of Clinical Affairs
Global Orthopaedic Technology
PO Box 7745
Baulkham Hills BC NSW 2153
Country 67735 0
Australia
Phone 67735 0
+61 2 8887 0100
Fax 67735 0
Email 67735 0
[email protected]
Contact person for scientific queries
Name 67736 0
Dr Omar Khorshid
Address 67736 0
Fremantle Hospital
Orthopaedics Department
Alma St.
Fremantle WA 6160
Country 67736 0
Australia
Phone 67736 0
+61 8 9431 2556
Fax 67736 0
Email 67736 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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