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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04211857
Ethics application status
Date submitted
23/12/2019
Date registered
26/12/2019

Titles & IDs
Public title
Retro-prospective Study of Safety & Performance of Round XTENDOBUTTON™ Fixation Device Post Knee Repair
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
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Fixation success of the Round XTENDOBUTTON™ at 12 months post operation
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Lysholm Score
Timepoint [2] 0 0
6 and 12 months
Secondary outcome [3] 0 0
Tegner Activity Scale
Timepoint [3] 0 0
6 & 12 months
Secondary outcome [4] 0 0
KOOS Score (Knee Injury and Osteoarthritis Outcome Score)
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
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Radiographic evaluation at 12 months
Timepoint [7] 0 0
12 months

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.
Minimum age
18 Years
Maximum age
60 Years
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2021
Sample size
Target
Accrual to date
Final
40
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04211857