Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001068257
Ethics application status
Approved
Date submitted
3/12/2009
Date registered
14/12/2009
Date last updated
14/01/2020
Date data sharing statement initially provided
14/01/2020
Date results information initially provided
14/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Multi-Center, Open-Label, Interventional Study of Patients with Medial
Compartment Knee Osteoarthritis (OA) treated with the KineSpring (Registered Trademark) System
Scientific title
A Multi-Center, Open-Label, Interventional Study to assess pain relief in Patients with Medial Compartment Knee Osteoarthritis (OA) treated with the KineSpring(Registered Trademark) System
Secondary ID [1] 1194 0
Nil
Universal Trial Number (UTN)
Trial acronym
OAKS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medial Knee Osteoarthritis 252246 0
Condition category
Condition code
Musculoskeletal 252433 252433 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The currently used device name is the KineSpring System.
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 (which should take approximately two hours)
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] 241579 0
Treatment: Devices
Intervention code [2] 241580 0
Treatment: Surgery
Comparator / control treatment
Single arm, patients serve as their own control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253309 0
The primary objective of this study is to demonstrate that the KineSpring System
provides pain relief Western Ontario and MacMaster University Osteoarthritis Index
(WOMAC LK 3.1A) over 26 weeks as compared to baseline, using
patients as their own controls.
Timepoint [1] 253309 0
26 weeks following surgery
Primary outcome [2] 253310 0
Safety will be determined using the incidence of treatment-emergent adverse events, and
physical examination findings.

Possible adverse events can include: 1-Irritation or inflammation to the surrounding tissues,
2 - Discomfort or sensitivity, 3 - Device failure, 4 - Infection which could lead to device removal
Timepoint [2] 253310 0
6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months following surgery
Secondary outcome [1] 262353 0
Procedural success - This outcome will be
assessed post-operatively based on successful
completion of implantation.
Timepoint [1] 262353 0
Immediately post-operatively
Secondary outcome [2] 262354 0
Determine benefits of the KineSpring System implant by assessing patient reported
symptom severity changes in WOMAC score, Oxford Knee Score, Knee pain severity
score, and patient global assessment, overall treatment outcome and patient satisfaction, and SF-36 General Health Outcomes
Timepoint [2] 262354 0
6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months following surgery
Secondary outcome [3] 262355 0
Determine benefits of the KineSpring System implant by assessing change in
investigator reported symptom severity in Knee Society Score, and physician global
assessment.
Timepoint [3] 262355 0
6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months following surgery
Secondary outcome [4] 262356 0
Evaluate changes in imaging outcomes as measured by Magnetic Resonance Imaging (MRI) and X-ray evaluations compared to baseline
Timepoint [4] 262356 0
6 Months, 12 Months, 24 months, 36 months, 48 months, and 60 months following surgery

Eligibility
Key inclusion criteria
Male or Female Subjects at least 30 years of age with a minimum 3 month history of primary OA in target knee, with radiographic evidence of OA, continuing pain despite conservative treatment, minimum WOMAC score (Q –A1) of 2, maximum weight of 300 pounds or 136.4 kg.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active infection, sepsis, osteomyelitis or history of septic arthritis in any
Joint, 2. Rheumatoid arthritis or other forms of inflammatory joint disease, 3. Modified Kellgren-Lawrence Numerical grading System of grade IV in the patello-femoral compartment of the target, 4. Previous surgery in the target knee within the 3 months prior to screening, 5. Varus alignment >10 degrees, 6. Ligamentous laxity, or meniscal instability as assessed by the investigator, 7. Uncontrolled diabetes mellitus, 8. Moderate to severe osteoporosis, 9. Concomitant immunosuppressive therapy, 10. Metabolic disorders which may impair bone formation, 11. Osteomalacia
12. Distant foci of infections which may spread to the implant site, 13. Rapid joint destruction, marked bone loss or bone resorption apparent on x-ray, 14. Vascular insufficiency, muscular atrophy, neuromuscular disease, 15. Incomplete or deficient soft tissue surrounding the knee, 16. Flexion deformity greater than 15 degrees, 17. Pregnancy or lactation
18. Prisoners

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
6/11/2009
Actual
24/11/2009
Date of last participant enrolment
Anticipated
25/08/2011
Actual
25/08/2011
Date of last data collection
Anticipated
Actual
24/08/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2255 0
2010
Recruitment postcode(s) [2] 2256 0
4000

Funding & Sponsors
Funding source category [1] 244059 0
Commercial sector/Industry
Name [1] 244059 0
Moximed, Inc
Country [1] 244059 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Moximed, Inc
Address
46602 Landing Parkway, Fremont, CA 94539
Country
United States of America
Secondary sponsor category [1] 251405 0
None
Name [1] 251405 0
Address [1] 251405 0
Country [1] 251405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258153 0
St. Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 258153 0
406 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 258153 0
Australia
Date submitted for ethics approval [1] 258153 0
Approval date [1] 258153 0
21/04/2009
Ethics approval number [1] 258153 0
1/09/0029
Ethics committee name [2] 258154 0
Mater Health Services
Ethics committee address [2] 258154 0
Level 2 Aubigny Place
Raymond Tce South Brisbane Qld 4101
Ethics committee country [2] 258154 0
Australia
Date submitted for ethics approval [2] 258154 0
Approval date [2] 258154 0
10/07/2009
Ethics approval number [2] 258154 0
1326E

Summary
Brief summary
This study is a multi-center, prospective, open
label, safety/efficacy study enrolling up to 30 patients.
Safety and efficacy are the primary objectives
based on
analysis of reported and observed adverse
events and the WOMAC validated OA questionnaire(pain component). 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, 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 6 months, 12, 24, 36, 48, and 60 months.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 30533 0
Dr David Hayes
Address 30533 0
Brisbane Orthopaedic and Sports Medicine Centre
Level 5, 259 Wickham Terrace
Brisbane QLD 4000
Country 30533 0
Australia
Phone 30533 0
+61 438347075
Fax 30533 0
Email 30533 0
[email protected]
Contact person for public queries
Name 13780 0
Dr Vijaya Krishnamoorthy
Address 13780 0
Moximed Inc., 46602 Landing Parkway, Fremont, CA 94539
Country 13780 0
United States of America
Phone 13780 0
+1 510 887 3328
Fax 13780 0
+1 510 372 0775
Email 13780 0
[email protected]
Contact person for scientific queries
Name 4708 0
Dr Anton Clifford
Address 4708 0
Moximed Inc., 46602 Landing Parkway, Fremont, CA 94539
Country 4708 0
United States of America
Phone 4708 0
+1-510-887-3300
Fax 4708 0
+1-510-880-7307
Email 4708 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
Dimensions AIThe KineSpring<sup>&reg;</sup> Knee Implant System: an implantable joint-unloading prosthesis for treatment of medial knee osteoarthritis2013https://doi.org/10.2147/mder.s44385
N.B. These documents automatically identified may not have been verified by the study sponsor.