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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04211857




Registration number
NCT04211857
Ethics application status
Date submitted
23/12/2019
Date registered
26/12/2019
Date last updated
5/02/2020

Titles & IDs
Public title
Retro-prospective Follow-up Study of Safety & Performance of Round XTENDOBUTTON™ Fixation Device Post Knee Repair in Australian Centres
Scientific title
A Retro-prospective Follow-up Study of the Safety and Performance of the Round XTENDOBUTTON™ Fixation Device Post Knee Repair in Australian Centres
Secondary ID [1] 0 0
XTENDO.PMCF.2018.12
Universal Trial Number (UTN)
Trial acronym
XTENDOBUTTON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Reconstruction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Round XTENDOBUTTON Fixation Device used in suture fixation of ligaments and tendons in conjunction with an ULTRABUTTON™ product or ENDOBUTTON™ device.

Treatment: Devices: Round XTENDOBUTTON Fixation Device used in suture fixation of ligaments and tendons in conjunction with an ULTRABUTTON™ product or ENDOBUTTON™ device.
Round XTENDOBUTTON Fixation Device used in suture fixation of ligaments and tendons in conjunction with an ULTRABUTTON™ product or ENDOBUTTON™ device.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Success of the Round XTENDOBUTTON™ Fixation - The fixation success at 6 months post knee operation with the XTENDOBUTTON™ device. The Kaplan-Meier product limit survival estimates will be presented up to 6 months post-op along with the associated 95% confidence intervals. The event of interest will be fixation failure, defined as a revision due to a device failure, by 6 months.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Fixation success of the Round XTENDOBUTTON™ at 12 months post operation - Fixation success of the Round XTENDOBUTTON™ at 12 months post operation. The Kaplan-Meier product limit survival estimates will be presented up to 12 months post-op along with the associated 95% confidence intervals. The event of interest will be fixation failure, defined as a revision due to a device failure, by 12 months.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Lysholm Score - The Lysholm Scale evaluates the outcomes of knee ligament surgery. The Lysholm Scale currently consists of eight items that measure: pain (25 points), instability (25 points), locking (15 points), swelling (10 points), limp (5 points), stair climbing (10 points), squatting (5 points), and need for support (5 points). The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability
Timepoint [2] 0 0
6 and 12 months
Secondary outcome [3] 0 0
Tegner Activity Scale - The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10. Each value indicates the ability to perform specific activities. An activity level of 10 corresponds to participation in competitive sports, including soccer, football, and rugby at the elite level; an activity level of 6 points corresponds to participation in recreational sports; and an activity level of 0 is assigned if a person is on sick leave or receiving a disability pension because of knee problems. An activity level of 5 to 10 is recorded only if the patient participates in recreational or competitive sports.
Timepoint [3] 0 0
6 & 12 months
Secondary outcome [4] 0 0
KOOS Score (Knee Injury and Osteoarthritis Outcome Score) - The Knee Injury and Osteoarthritis Outcome Score (KOOS) is self administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee related quality of life.
Timepoint [4] 0 0
6 & 12 months
Secondary outcome [5] 0 0
Adverse events for the study duration
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Radiographic evaluation at 6 months - Radiographic evaluation will be completed if an implant failure has occurred. Radiographic evaluations (if needed to investigate root cause of a device failure) will be summarized at 6 months.
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Radiographic evaluation at 12 months - Radiographic evaluation will be completed if an implant failure has occurred. Radiographic evaluations (if needed to investigate root cause of a device failure) will be summarized at 12 months.
Timepoint [7] 0 0
12 months

Eligibility
Key inclusion criteria
1. Subject received the Round XTENDOBUTTON™ for knee repair, 6 months (-7 Days/+14 Days)
prior to enrollment

2. Subject agrees to follow the prospective study visit schedule (as defined in the study
protocol and informed consent form) by signing the IRB/IEC approved informed consent
form

3. Subject is = 18 years of age or = 60 years of age at the time of surgery.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject is entered in another investigational drug, biologic, or device study

2. Subjects with a medical or physical condition that, in the opinion of the
Investigator, would preclude safe subject participation in the study

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
Recruitment hospital [1] 0 0
Peninsula Orthapaedics - Frenchs Forest
Recruitment postcode(s) [1] 0 0
2086 - Frenchs Forest

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The 12 month post-operative study is designed to provide safety and performance data on the
Round XTENDOBUTTON™ fixation device after knee repair.
Trial website
https://clinicaltrials.gov/show/NCT04211857
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Chia, MBBS, FRACS (Ortho), FAOrthA
Address 0 0
PORI- Peninsula Orthopedic Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gursharan Dhamrait
Address 0 0
Country 0 0
Phone 0 0
+61 2 9857 3978
Fax 0 0
Email 0 0
Gursharan.Dhamrait@smith-nephew.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04211857