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Trial registered on ANZCTR


Registration number
ACTRN12607000422426
Ethics application status
Approved
Date submitted
4/08/2007
Date registered
21/08/2007
Date last updated
21/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety Study of the iBalance Axial Knee Realignment System (AKRFX)
Scientific title
12 month study to evaluate the safety and performance of the iBalance Axial Knee Realignment System in patients with symptomatic knee pain, displaying medial compartment osteoarthritis with varus malalignment
Secondary ID [1] 452 0
ClinicalTrials.gov: 2007-07-20
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 2276 0
Condition category
Condition code
Musculoskeletal 2368 2368 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will have a high tibial osteotomy performed using the AKRFX System with the implant and anchors. The implant and anchors are intended to be permanent though they can be removed if necessary. Patients in the historical control group will have received osteotomy using currently available systems. No contact will be made with these patients. All information will be obtained from an existing database at the Fowler Kennedy Sports Medicine Clinic in London, Ontario Canada
Intervention code [1] 1929 0
Treatment: Surgery
Intervention code [2] 1987 0
Treatment: Devices
Comparator / control treatment
The historical control group will be comprised of patients matched on age, gender, Body Mass Index and degree of preoperative malalignment. The patients are part of an existing database of patients having had high tibial osteotomy using currently available systems, at Fowler Kennedy Sports Medicine Clinic in Ontario Canada.
Control group
Historical

Outcomes
Primary outcome [1] 3266 0
Incidence of expected and unexpected adverse events (e.g. infection, deep vein thrombosis, delayed union, lateral cortex fractures, collapse of the osteotomy)
Timepoint [1] 3266 0
From procedure to 12 months post-operation with evaluations at 6 weeks, 3 months, 6 months and 12 months post-operation.
Primary outcome [2] 4275 0
Bone healing as measured by patients' ability to withstand full weightbearing without crutches and show no clinical signs of non-union or delayed union
Timepoint [2] 4275 0
From procedure to 12 months post-operation with evaluations at 2 weeks, 6 weeks, 3 months, 6 months and 12 months post-operation.
Secondary outcome [1] 5447 0
Radiographic evidence of non-union or delayed union including complications such as radiolucency around the implant resorption within the osteotomy, or collapse of the osteotomy as measured by the evaluation of anteroposterior (A/P) knee X-rays
Timepoint [1] 5447 0
Post-operation baseline and at 6 weeks, 3 months, 6 months and 12 months post-operation
Secondary outcome [2] 7208 0
Stability of the implant in the bone evaluated by measurement of the osteotomy angle in A/P knee X-rays
Timepoint [2] 7208 0
Post-operation baseline, 6 weeks, 3 months, 6 months and 12 months post-operation.
Secondary outcome [3] 7209 0
Quality of life as measured by the SF-36 and KOOS Knee Survey
Timepoint [3] 7209 0
Pre-operation baseline and then 3 months, 6 months and 12 months post-operation

Eligibility
Key inclusion criteria
Require 3-12 degrees of varus correction
Localized pain in posterior-medial quadrant of knee
Grades II, III, and IV medial compartment knee osteoarthritis (Kellgren-Lawrence Scale)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Diabetes (any type or status) or any metabolic disorder or other condition which may impair bone formation (e.g. osteoporosis)
2) Inflammatory joint disease
3) Patients who, in the opinion of the investigator, have a medical condition that would preclude this patient from completing the study (e.g. concurrent chronic illness such as neuropathy, HIV, cancer or other terminal illness)
4) Previous reconstructive surgery that would prohibit use of the AKRFX system or compromise the AKRFX surgical technique
5) Previous lateral meniscectomy greater than 30%
6) Previous knee osteotomies in the study knee
7) Previous patellectomy
8) Gross tibial tubercle deformity
9) Cruciate ligament instability with Lachman Test, Grade 2 or higher
10) Posterior Draw Test, Grade 2 or higher
11) Evidence of Grade 3 or higher lateral compartment osteoarthritis (Kellgren Lawrence Scale)
12) Evidence of Grade 3 or higher patella osteoarthritis (Kellgren Lawrence Scale)
13) Proximal tibial width < 64 mm or > 88 mm
14) Current smoker or quit smoking less than one year ago
15) Body Mass Index over 35

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Historical controls will be matched on age, gender, body mass index (BMI) and degree of pre-operative malalignment. The historical controls had high tibial osteotomy performed using one of the currently available metal plate and screw systems.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 557 0
Canada
State/province [1] 557 0
Ontario

Funding & Sponsors
Funding source category [1] 2475 0
Commercial sector/Industry
Name [1] 2475 0
iBalance Medical Inc.
Country [1] 2475 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
iBalance Medical Inc.
Address
4900 Nautilus Ct., Suite 100, Boulder, CO 80304
Country
United States of America
Secondary sponsor category [1] 2248 0
Charities/Societies/Foundations
Name [1] 2248 0
Sydney Orthopaedic Research Institute
Address [1] 2248 0
Level 1, The Gallery, 445 Victoria Ave., Chatswood, NSW 2067
Country [1] 2248 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4377 0
Fowler Kennedy Sports Medicine Clinic
Ethics committee address [1] 4377 0
London
Ontario
Ethics committee country [1] 4377 0
Canada
Date submitted for ethics approval [1] 4377 0
Approval date [1] 4377 0
Ethics approval number [1] 4377 0
Ethics committee name [2] 4378 0
Sydney Orthopaedic Research Institute
Ethics committee address [2] 4378 0
Sydney NSW
Ethics committee country [2] 4378 0
Australia
Date submitted for ethics approval [2] 4378 0
Approval date [2] 4378 0
Ethics approval number [2] 4378 0
Ethics committee name [3] 4379 0
PanAm Clinic
Ethics committee address [3] 4379 0
Winnipeg
Manitoba
Ethics committee country [3] 4379 0
Canada
Date submitted for ethics approval [3] 4379 0
Approval date [3] 4379 0
Ethics approval number [3] 4379 0

Summary
Brief summary
This is a 12 month study seeking to enroll patients with symptomatic knee pain caused by osteoarthritis, who are bowlegged (with varus malalignment). The study will evaluate the safety of a new implant designed to realign the lower leg. Realignment can prevent further progress of osteoarthritis, decrease pain and allow individuals to return to more normal activity. In order to evaluate the safety of the system the study will collect information on any problems patients may experience during the surgery and recovery (up to 12 months), X-rays of the leg to evaluate bone healing and stability of the implant, and answers to surveys with questions about how patients are feeling and what their activity level is. This information will then be compared to a matched group of patients who had a high tibial osteotomy performed with a currently available metal plate and screw system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27743 0
Address 27743 0
Country 27743 0
Phone 27743 0
Fax 27743 0
Email 27743 0
Contact person for public queries
Name 11118 0
Kelly Ammann
Address 11118 0
Suite 100
4900 Nautilus Ct.
Boulder CO 80301
Country 11118 0
United States of America
Phone 11118 0
011 1 303 381 6333 x 101
Fax 11118 0
011 1 303-530-0530
Email 11118 0
[email protected]
Contact person for scientific queries
Name 2046 0
Kelly Ammann
Address 2046 0
4900 Nautilus Ct.
Suite 100
Boulder CO 80301
Country 2046 0
United States of America
Phone 2046 0
011 1 303 381 6333 x 101
Fax 2046 0
011 1 303-530-0530
Email 2046 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

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