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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04211857
Registration number
NCT04211857
Ethics application status
Date submitted
23/12/2019
Date registered
26/12/2019
Date last updated
10/05/2022
Titles & IDs
Public title
Retro-prospective Study of Safety & Performance of Round XTENDOBUTTON™ Fixation Device Post Knee Repair
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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
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Secondary ID [1]
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XTENDO.PMCF.2018.12
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Universal Trial Number (UTN)
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Trial acronym
XTENDOBUTTON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee Reconstruction
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Success of the Round XTENDOBUTTON™ Fixation
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Assessment method [1]
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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.
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Fixation success of the Round XTENDOBUTTON™ at 12 months post operation
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Assessment method [1]
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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.
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Lysholm Score
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Assessment method [2]
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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
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Timepoint [2]
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6 and 12 months
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Secondary outcome [3]
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Tegner Activity Scale
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Assessment method [3]
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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.
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Timepoint [3]
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6 & 12 months
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Secondary outcome [4]
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KOOS Score (Knee Injury and Osteoarthritis Outcome Score)
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Assessment method [4]
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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.
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Timepoint [4]
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6 & 12 months
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Secondary outcome [5]
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Adverse events for the study duration
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Assessment method [5]
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Timepoint [5]
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12 months
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Secondary outcome [6]
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Radiographic evaluation at 6 months
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Assessment method [6]
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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.
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Timepoint [6]
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6 months
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Secondary outcome [7]
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Radiographic evaluation at 12 months
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Assessment method [7]
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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.
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Timepoint [7]
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12 months
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Eligibility
Key inclusion criteria
1. Subject received the Round XTENDOBUTTON™ for knee repair, 6 months (-14 Days/+31 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.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/10/2021
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peninsula Orthapaedics - Frenchs Forest
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Recruitment postcode(s) [1]
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2086 - Frenchs Forest
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Smith & Nephew, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04211857
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sam Chia, MBBS, FRACS (Ortho), FAOrthA
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Address
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PORI- Peninsula Orthopedic Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04211857
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