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Trial registered on ANZCTR


Registration number
ACTRN12608000451303
Ethics application status
Approved
Date submitted
12/07/2008
Date registered
15/09/2008
Date last updated
29/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and Feasibility of a Load Bypass Knee Support System (LBKSS) for the Treatment of Osteoarthritis
Scientific title
Safety and Feasibility of a Load Bypass Knee Support System (LBKSS) for the Treatment of Osteoarthritis
Secondary ID [1] 286808 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
OASYS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 3405 0
Condition category
Condition code
Musculoskeletal 3552 3552 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The currently used device name is the LBKSS. The device is a permanent implant that is fixed on the femoral and tibial components of the knee. The implant is achieved in a single surgery and left permanently in place.
Each subject will undergo a surgical procedure to implant a permanent knee support device that is an alternative to traditional knee surgeries to treat osteoarthritis (OA) of the knee
Intervention code [1] 3128 0
Treatment: Surgery
Intervention code [2] 3129 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4455 0
Feasibility of Implantation - This outcome will be assessed post-operatively based on successful completion of implantation.
Timepoint [1] 4455 0
Intra-operative
Primary outcome [2] 4456 0
Incidence of adverse events - The endpoint for the evaluation of the safe performance of the LBKSS will be the frequency, duration, severity and outcome of adverse events collected during the procedure and throughout the study. The relationship of each observed adverse event to the device and the procedure will be assessed and recorded. The severity of the adverse event and its reported relation to the presence of an LBKSS will also be characterized.

Types of possible complications include those associated with surgery (i.e., anesthesia complications, bleeding, infection) and possible complications associated with the device (i.e., allergic reaction, device dislocation or instability, fracture, pain or irritation, tissue wear). Adverse events will be classified as to the severity and relationship to the device/procedure, using a scale of mild, moderate, or severe.
Timepoint [2] 4456 0
The follow-up time points for the study are 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and annually thereafter for the 5 year duration of the study.
Secondary outcome [1] 7526 0
Patient Reported Outcomes - Pain Status (Visual Analogue Scale), SF-36, Western Ontario and MacMaster University (WOMAC), Oxford Knee Score, Lysholm, Tegner, and Hospital for Special Surgery Scale (HSS)
Timepoint [1] 7526 0
All Questionnaires at baseline and at regular intervals through 2 years. Select questionnaires will also be administered annually through 5 years.

The follow-up time points for the study are 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and annually thereafter for the 5 year duration of the study.


SF-36, WOMAC, And HSS will be administered annually after the completion of the 24 month visit
Secondary outcome [2] 7527 0
Radiographic Imaging - to assess the appearance of knee joint compared to baseline
Timepoint [2] 7527 0
At baseline, 6 months, 12 months, 24 months, & 5 years

Eligibility
Key inclusion criteria
Subjects who have previously failed medical therapy for OA of the knee weighing less than 125kgs and are willing and able to comply with the study requirements
Minimum age
30 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Knees that are multi-dimensionally unstable in addition to being Anterior cruciate ligament (ACL) deficient
2) Uncontrolled diabetes
3) Rheumatoid Arthritis of the knee
4) Active Smoker
5) Previous knee prosthesis in the affected knee
6) History of major traumatic injury in the affected knee
7) Moderate to severe osteoporosis
8) Lateral compartment OA
9) Mild to severely symptomatic Patello-Femoral disease
10) Arthroscopic surgery with the previous 3 months

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
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 999 0
2000
Recruitment postcode(s) [2] 1000 0
4000

Funding & Sponsors
Funding source category [1] 3587 0
Commercial sector/Industry
Name [1] 3587 0
Moximed (formerly ExploraMed NC4)
Address [1] 3587 0
26460 Corporate Ave
Suite 100
Hayward, CA 94545
Country [1] 3587 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Moximed (formerly ExploraMed NC4)
Address
26460 Corporate Ave,
Suite 100
Hayward, Ca 94545
Country
United States of America
Secondary sponsor category [1] 3224 0
None
Name [1] 3224 0
Address [1] 3224 0
Country [1] 3224 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5633 0
South Eastern Sydney and Illawarra Area Health Service Human Research Ethics Committee - Northern Network
Ethics committee address [1] 5633 0
Room G71, East Wing
Edmund Blackett Bldg
Prince of Wales Hospital
Cnr High & Avoca Streets
Randwick NSW 2031
Ethics committee country [1] 5633 0
Australia
Date submitted for ethics approval [1] 5633 0
28/03/2008
Approval date [1] 5633 0
23/05/2008
Ethics approval number [1] 5633 0
08/003
Ethics committee name [2] 7063 0
St Vincents HREC
Ethics committee address [2] 7063 0
Level 6 DeLacy Bldg, 390 Victoria Street, Darlinghurst 2010
Ethics committee country [2] 7063 0
Australia
Date submitted for ethics approval [2] 7063 0
23/06/2008
Approval date [2] 7063 0
25/11/2008
Ethics approval number [2] 7063 0
08/141
Ethics committee name [3] 7064 0
St Vincents Holy Spirit HREC
Ethics committee address [3] 7064 0
PO Box 555, Spring Hill QLD
Ethics committee country [3] 7064 0
Australia
Date submitted for ethics approval [3] 7064 0
11/01/2008
Approval date [3] 7064 0
23/05/2008
Ethics approval number [3] 7064 0
08/01
Ethics committee name [4] 7065 0
Mater Health Services
Ethics committee address [4] 7065 0
Aubigny Place, Raymond Terrace, St Brisbane QLD
Ethics committee country [4] 7065 0
Australia
Date submitted for ethics approval [4] 7065 0
21/04/2008
Approval date [4] 7065 0
12/08/2008
Ethics approval number [4] 7065 0
1223E

Summary
Brief summary
This study is a multi-center, prospective, open label, feasibility study enrolling up to 30 patients. Safety and feasibility are the primary objectives based on completion of surgical implantation and analysis of reported and observed adverse events. A series of validated subject-completed questionnaires, a visual analogue scale for pain and formal orthopaedic examination, will be performed over the course of the 60 months at the following intervals: baseline, 24-48 hours post-op, 2 weeks, 6 weeks, 3 months, 6, 12, 24, 36, 48 and 60 months. X-ray and/or MRI data will be collected pre-operatively and the following post operative intervals, 2 weeks, 6 months, 12 months, 24 months and 60 months.
Trial website
Trial related presentations / publications
1. Hayes et al. Safety and Feasibility of a KineSpring Knee System for the Treatment of Osteoarthritis: A Case Series. Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders 2015:8 47–54 doi: 10.4137/CMAMD.S24423.
2. Hayes et al. Knee Osteoarthritis Treatment with the KineSpring Knee
Implant System: A Report of Two Cases Case Reports in Orthopedics, Volume 2012, Article ID 297326, 6 pages doi:10.1155/2012/297326
3. London et al. Midterm Outcomes and Predictors of Clinical Success With the KineSpring Knee Implant System, Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders 2013:6 19–28 doi: 10.4137/CMAMD.S11768
4. Hayes et al. Unloading the Osteoarthritic Knee with the KineSpring System: Surgical Technique and Early Clinical Results, Chapter 8, ESKAA Best Practices
Public notes

Contacts
Principal investigator
Name 28746 0
Dr David Hayes
Address 28746 0
Brisbane Orthopaedic and Sports Medicine Center
Level 5, 259 Wickham Terrace
Brisbane 4000 QLD
Country 28746 0
Australia
Phone 28746 0
+61 438347075
Fax 28746 0
Email 28746 0
d.hayes@bosmc.com.au
Contact person for public queries
Name 11903 0
Ms Tessa Yamut
Address 11903 0
26460 Corporate Ave
Suite 100
Hayward, CA 94545
Country 11903 0
United States of America
Phone 11903 0
+1 510 887 3389
Fax 11903 0
+1 510 372 0794
Email 11903 0
tyamut@moximed.com
Contact person for scientific queries
Name 2831 0
Dr Anton Clifford
Address 2831 0
26460 Corporate Ave
Suite 100
Hayward, CA 94545
Country 2831 0
United States of America
Phone 2831 0
+1 510 887 3343
Fax 2831 0
+1 510 880 7307
Email 2831 0
aclifford@moximed.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary