ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000071426

Ethics application status

Approved

Date submitted

28/11/2015

Date registered

22/01/2016

Date last updated

22/01/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

The use of accelerometer-based, computer navigation versus conventional alignment guides in achieving accurate implant position for Total Knee Replacement surgery

Scientific title

Conventional versus accelerometer-based, portable navigation system (KneeAlign 'Registered Trademark') for total knee arthroplasty: A prospective randomized comparative trial.

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1176-9878

Trial acronym

TKA (Total Knee Arthroplasty)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Total Knee Arthroplasty for Knee Osteoarthritis

Condition category

Condition code

Surgery

Surgical techniques

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A comparison of alignment outcomes of total knee arthroplasty (TKA) using accelerometer based navigation vs traditional intramedullary guides.
Navigation will be performed using KneeAlign2 (OrthAlign, Aliso Viejo, CA) which is a handheld, accelerometer-based surgical navigation system consisting of a display console and reference sensor designed to assist the surgeon in performing accurate proximal tibia and distal femur cuts in both the coronal and sagittal planes.
Surgeries will be performed by a fellowship trained orthopedic surgeons (Samuel Macdessi and Darren Chen), and the expexted duration of surgery from skin incision to application of dressing is around 1.5 hour.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Control group:
Total knee artroplasty using traditional intramedullary guides for both femur and tibial cuts. in this technique the cutting jigs for the proximal tibia and distal femur correlates with the anatomical axes for the tibia and femur respectively identified by inserting a fitting rigid rod in the medullary canals.
Surgeries will be performed by a fellowship trained orthopedic surgeons (Samuel Macdessi and Darren Chen), and the expexted duration of surgery from skin incision to application of dressing is around 1.5 hour.

Control group

Active

Outcomes

Primary outcome [1]

Overall lower limb alignment in the coronal plane assessed by Computed Tomography (CT) imaging based on the Perth protocol.

Timepoint [1]

Second day post surgery

Primary outcome [2]

Individual component alignment (tibial component) in the coronal, sagittal and axial planes assessed by CT Perth protocol

Timepoint [2]

Second day post surgery

Primary outcome [3]

Individual component alignment (femoral component) in the coronal, sagittal and axial planes assessed by CT Perth protocol.

Timepoint [3]

Second day post surgery

Secondary outcome [1]

Knee function and pain will be assessed using the Knee Society Score (KSS)

Timepoint [1]

- Preoperatively
- 6 weeks postoperatively
- 6 months postoperatively

Secondary outcome [2]

knee function and patient symptoms will be assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS)

Timepoint [2]

- Preoperatively
- 6 weeks postoperatively
- 6 months postoperatively

Eligibility

Key inclusion criteria

Age 40 - 90
No racial nor gender bias
Undergoing unilateral TKA for degenerative osteoarthritis

Minimum age

40 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Revision TKA surgery
* Bilateral simultaneous TKA
* Prior osteotomies around the knee or extra-articular deformities
* Systemic inflammatory disease (e.g. Rheumatoid arthritis, Systemic lupus erythematosus, etc)
* Medial and lateral knee ligamental instability & prior surgery specific to this
* Knee replacement for acute trauma
* Need for allograft, , constrained implants, stemmed components or metal augmentation during surgery

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)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

* Pre:
Based on power analysis, a sample size of 70 patients in each cohort would provide appropriate power (beta level = 0.80, alpha level = 0.05) to detect a 20% improvement in accuracy between the two groups (obtaining femoral & tibial resections to within 2 degrees of their respective mechanical axes).
* During:
There will be a midterm analysis when 100 patients are recruited to assess whether significance has been reached and whether or not, further patient enrollment is necessary.
* Post:
Student’s t-tests to compare differences in means between continuous variables
Fisher’s exact test for significance in difference of alignment (proportions) between groups
Statistical significance was set at p<0.05

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

1/07/2015

Date of last participant enrolment

Anticipated

15/02/2016

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

140

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St George Private Hospital - Kogarah

Recruitment hospital [2]

Canterbury Hospital - Campsie

Recruitment postcode(s) [1]

2217 - Kogarah

Recruitment postcode(s) [2]

2194 - Campsie

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Other Collaborative groups

Name

Sydney Knee Specialists

Address

19 Kensington street
Kogarah 2217
NSW

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Research Support and Development Office/ Research Office and Governance Unit

Ethics committee address [1]

Locked bag 1, New Lambton, NSW, 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/03/2015

Approval date [1]

05/05/2015

Ethics approval number [1]

15/03/18/3.05

Summary

Brief summary

Background:
The KneeAlign 'Registered Trademark' is an accelerometer-based, electronic, portable device which was designed for use in navigational total knee arthroplasty. There is literature which supports its efficacy and safety in achieving satisfactory knee alignment following total knee arthroplasty. However, most studies on the device has come from the designer unit and further information gathered from independent operators will be important. Its potential benefit is in the area of navigated arthroplasty as it is less-bulky than current navigation equipment and may prove important in complex surgeries where navigation is most useful. The risks are minimal and may even protect the medullary canal (as this is invaded using conventional alignment guides). The patient receives the same implant by the same surgeon and this device is to be used solely as an aid in achieving accurate bony cuts during surgery.  
This study will compare conventional guides and the navigation device in question. The trial will be conducted in compliance with the protocol laid out, GCP and the ethics regulations. The study will look at patients who are undergoing routine total knee replacement for osteoarthritis (the most common reason for prosthetic replacement).

Trial Objectives:
To prospectively compare patient-reported outcome measures and radiological results between conventionally guided and accelerometer-based navigation in patients undergoing total knee replacement surgery. Specifically, we will compare pain and functional scores together with mechanical axes correction in both sagittal and coronal planes. 

trial will be a prospective, patient-blinded, randomised comparative study with the end-points being patient-reported outcome measures, radiological results and duration of surgery. Patient consent and ethical approval will be obtained prior to trial commencement.

Clinical outcome measures would be assessed via the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome score (KOOS) questionnaires which are both validated patient reported outcome measures following knee arthroplasty. These questionnaires will be taken at the time of standard appointments (pre-surgery & 6 months). Radiological outcomes will be assessed via CT imaging studies pre and post op using the CT Perth Protocol (To assess for mechanical & anatomical alignment).
Patients will be recruited at the time when a decision to proceed with a knee arthroplasty is made during consultation.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Samuel Macdessi

Address

Sydney Knee Specialists, Suite 8, 19, Kensington St, Kogarah NSW 2217

Country

Australia

Phone

+61283070333

Fax

samuelmacdessi@sydneyknee.com.au

Contact person for public queries

Name

Samuel Macdessi

Address

Sydney Knee Specialists, Suite 8, 19, Kensington St, Kogarah NSW 2217

Country

Australia

Phone

+61283070333

Fax

samuelmacdessi@sydneyknee.com.au

Contact person for scientific queries

Name

Samuel Macdess

Address

Sydney Knee Specialists, Suite 8, 19, Kensington St, Kogarah NSW 2217

Country

Australia

Phone

+61283070333

Fax

samuelmacdessi@sydneyknee.com.au

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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