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Trial registered on ANZCTR


Registration number
ACTRN12613000421730
Ethics application status
Approved
Date submitted
4/04/2013
Date registered
16/04/2013
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
27/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of the KineSpring PEEK System in Improving Pain and Function in Patients with Knee Osteoarthritis (OA): A Multi-Center, Single Arm Pilot Study
Scientific title
A Multi-Center, Single Arm Pilot Study to assess improvement in Pain and Function in Patients with medial compartment Knee OA treated with the KineSpring PEEK System
Secondary ID [1] 282245 0
Nil
Universal Trial Number (UTN)
Trial acronym
PEEK-OA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medial Knee Osteoarthritis 288763 0
Condition category
Condition code
Musculoskeletal 289123 289123 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The currently used device name is the KineSpring PEEK 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 and alternative to traditional surgeries to treat osteoarthritis (OA) of the knee.
Intervention code [1] 286860 0
Treatment: Devices
Intervention code [2] 286861 0
Treatment: Surgery
Comparator / control treatment
Single arm, patients serve as their own control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289236 0
To demonstrate that the KineSpring PEEK System provides pain relief and improvement in function at 6 months as compared to baseline, using patients as their own controls. Pain and Function improvement will be assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) as derived from the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Timepoint [1] 289236 0
6 months following surgery
Primary outcome [2] 289237 0
Safety will be determined using the incidence of treatment-emergent adverse events (AEs), and physical examination findings in the first 6 months post procedure.

Possible adverse events can include but are not limited to: 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] 289237 0
6 Months following surgery
Secondary outcome [1] 302081 0
Procedural Success - as demonstrated by successful implantation of the KineSpring PEEK System
Timepoint [1] 302081 0
Immediately post-operatively
Secondary outcome [2] 302082 0
To determine benefits of the device by assessing patient reported symptom severity changes in WOMAC score, KOOS score, Knee pain severity score, patient global assessment and activity level, and HAAS score.
Timepoint [2] 302082 0
6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months following surgery.
Secondary outcome [3] 302083 0
To determine benefits of the device by assessing change in investigator reported symptom severity in Knee Society Score, and physician global assessment.
Timepoint [3] 302083 0
6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months following surgery.
Secondary outcome [4] 302084 0
To evaluate patient satisfaction with the procedure at each follow up visit using a patient satisfaction questionnaire.
Timepoint [4] 302084 0
6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months following surgery.
Secondary outcome [5] 302085 0
Radiographic appearance of the knee at each follow up X-Ray compared to baseline.
Timepoint [5] 302085 0
Immediately Post-op, 3 months, 6 months, 12 months, and 24 months following surgery.

Eligibility
Key inclusion criteria
1. Documented diagnosis of primary OA of the target knee made at least 6 months prior to screening, 2. Documented radiographic evidence of medial OA as demonstrated by a Kellgren-Lawrence grade of >=2 (scale 0-4) as assessed by the investigator, 3. Has continued target knee OA pain despite 6 months of conservative treatment prior to surgery, 4. Has pain in the target knee as demonstrated by a minimum score of 40 (scale 0-100) on the KOOS/WOMAC pain domain questions, 5. Aged minimum 25 years, 6. Knee flexion >=90 degrees to <=140 degrees, 7. Weight <300 lbs (136.4kg)
Minimum age
25 Years
Maximum age
No limit
Gender
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. Significant OA in lateral or patello-femoral compartment as measured by Kellgren Lawrence grade of 2 or 3, respectively, 4. Significant OA in the contralateral knee likely to necessitate surgical intervention within 12 months of enrollment, 5. Previous joint modifying surgery in the target knee within 12 months prior to planned surgery date such as ligament reconstruction or meniscus repair, cartilage transplantation, and microfracture - a. Arthroscopic surgeries for joint lavage, menisectomy, chondral debridement, and loose body removal are excluded if within 3 months prior to planned surgery date, 6. Previous osteotomy or failed knee joint replacement in the target knee, 7. Tibial-femoral varus or varus alignment >10 degrees, 8. Hyperextension >5degrees, 9. Flexion deformity greater than 10 degrees, 10. Ligamentous laxity, or meniscal instability as assessed by the investigator, 11. Uncontrolled diabetes mellitus, 12. Moderate to severe osteoporosis, 13. Concomitant immunosuppressive therapy, 14. Metabolic disorders which may impair bone formation, 15. Osteomalacia, 16. Distant foci of infections which may spread to the implant site, 17. Rapid joint destruction, marked bone loss or bone resorption apparent on x-ray, 18. Vascular insufficiency, muscular atrophy, neuromuscular disease, 19. Any significant medical condition or other factor that the Investigator feels would interfere with study participation, 20. Pregnancy or lactation, 21. 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
The primary efficacy analysis will be performed on all patients enrolled and implanted with the KineSpring PEEK System. The efficacy analysis will be based on a repeated measures model that will be used to test for treatment efficacy, as quantified by the WOMAC LK 3.1 Section A pain subscore over 26 weeks (6 months).

Missing efficacy data will be imputed using the Last Observation Carried Forward (LOCF) method.

The primary efficacy analysis may be repeated on the Per-Protocol Population, which will exclude all patients with major protocol violations.

The safety analyses will be performed on the safety populations defined as all patients who undergo the KineSpring PEEK System implant procedure. Treatment – emergent AEs will be summarized and categorized by severity and relation to the study procedures. If a patient has more than 1 occurrence of the same AE, he/she will be counted only once within that category in the summary tables. The most severe occurrence of an AE, as well as the most extreme relationship of the AE to the study device or implant procedure will be indicated in cases of multiple occurrences of the same AE. All AEs will be presented in a listing. Additionally listing of serious adverse events (SAEs) and AEs leading to discontinuation will be generated.

The number of anticipated and unanticipated adverse events that occur in the study population will be tabulated and summarized. In addition, the incidence of all types of adverse events will be reviewed during the course of the study for any indications that use of device confers any unanticipated significant risk.

The null hypothesis is that there will be no change in WOMAC pain scores from Baseline (pre-op) to Week 26. The alternative hypothesis is that WOMAC pain scores will be improved (reduced) at Week 26 compared to Baseline.

Preliminary data from a previous study (OAKS) showed improvements from baseline WOMAC pain scores ranging from 26.8 to 36.4 from 6 Weeks to 12 months after treatment. Standard deviations of those improvement scores ranged from 17.3 to 21.6. Conservatively assuming pain score improvement (Mu) of 26 with a standard deviation (Dev) of 22, a two-sided alpha level (Alpha) of 0.05 and a beta level (Beta) of 0.10 (90% power), sample size was calculated using the usual formula

N = (tAlpha + tBeta)^2 x Dev^2 / Mu^2

with t scores rather than the more usual Z scores because of the relatively small sample size required. Because t scores depend on sample size, an iterative recalculation procedure was necessary. Based on these calculations, a sample size of 10 patients was required.

Recruitment
Recruitment status
Active, not recruiting
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)
QLD
Recruitment hospital [1] 837 0
Brisbane Private Hospital - Brisbane
Recruitment postcode(s) [1] 6654 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 287013 0
Commercial sector/Industry
Name [1] 287013 0
Moximed, Inc.
Address [1] 287013 0
46602 Landing Parkway
Fremont, CA 94539
USA
Country [1] 287013 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Moximed, Inc.
Address
46602 Landing Parkway
Fremont, CA 94539
USA
Country
United States of America
Secondary sponsor category [1] 285796 0
None
Name [1] 285796 0
Address [1] 285796 0
Country [1] 285796 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289053 0
St. Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 289053 0
406 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 289053 0
Australia
Date submitted for ethics approval [1] 289053 0
Approval date [1] 289053 0
27/03/2012
Ethics approval number [1] 289053 0
11/199

Summary
Brief summary
This study is a multi-center, prospective, openlabel, safety/efficacy study enrolling up to 10 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, 18, 24,36, 48 and 60 months. X-ray data will be collected pre-operatively and the following post operative intervals 3, 6, 12, and 24 months.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 38990 0
Dr David Hayes
Address 38990 0
Brisbane Orthopaedic Sports Medicine Centre
Level 5
259 Wickham Terrace
Brisbane QLD 4000
Country 38990 0
Australia
Phone 38990 0
+61 07 3834 7075
Fax 38990 0
Email 38990 0
d.hayes@bosmc.com.au
Contact person for public queries
Name 38991 0
Ms Tessa Yamut
Address 38991 0
46602 Landing Parkway
Fremont, CA 94539
USA
Country 38991 0
United States of America
Phone 38991 0
+1-510-887-3389
Fax 38991 0
+1 510 372 0794
Email 38991 0
tyamut@moximed.com
Contact person for scientific queries
Name 38992 0
Mr Anton Clifford
Address 38992 0
46602 Landing Parkway
Fremont, CA 94539
USA
Country 38992 0
United States of America
Phone 38992 0
+1-510-887-3343
Fax 38992 0
+1-510-880-7307
Email 38992 0
aclifford@moximed.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
A final clinical study report will be prepared.
What supporting documents are/will be available?
Clinical study report
How or where can supporting documents be obtained?
Type [1] 518 0
Citation [1] 518 0
Link [1] 518 0
Email [1] 518 0
Other [1] 518 0
Report is pending
Attachment [1] 518 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary