Retro-prospective Study of Safety & Performance of Round XTENDOBUTTON Fixation Device Post Knee Repair

  • STATUS
    Recruiting
  • End date
    Jul 31, 2021
  • participants needed
    40
  • sponsor
    Smith & Nephew, Inc.
Updated on 29 November 2020
Investigator
Alison Walker
Primary Contact
Peninsula Orthapaedics (6.8 mi away) Contact

Summary

The 12 month post-operative study is designed to provide safety and performance data on the Round XTENDOBUTTON fixation device after knee repair.

Description

This is a retro-prospective 12 month follow-up study of the safety and performance of the Round XTENDOBUTTON fixation device post knee repair in Australian centres.

The Primary Objective is to assess successful fixation with the Round XTENDOBUTTON and the Secondary Objective is to generate safety and performance evidence for the Round XTENDOBUTTON Device via the collection of functional outcomes, patient reported outcomes and safety data.

Forty subjects will be enrolled; who have had the round XTENDOBUTTON Device implanted. To eliminate the potential for selection bias, Investigators will consecutively screen all subjects who have undergone knee/ligament repair/reconstruction using the Round XTENDOBUTTON Fixation Device. Subjects meeting the eligibility criteria will be contacted regarding interest in study participation. Screening will be conducted in sequential order based on the date of subjects' knee repair procedure; earliest to latest. Screening efforts must be documented on a screening and enrollment log, on which reasons for exclusion from or denial to participate should be noted A medical chart review will be conducted to identify potential study subjects who have been implanted with the ROUND XTENDOBUTTON device at the study site.

  1. If a patient is eligible and would like to participate in the study, obtain written informed consent from the subject.----- Do not proceed until consent has been obtained
  2. Assign the subject a Subject ID number and instruct the subject on treatment procedures
  3. Complete Screening and Enrollment Log
  4. Obtain demographic information and medical history, including information on all relevant concomitant medications
  5. Collect operative information and implant disposition (including review of evidence of implant failure). If a failure has occurred, record details of the cause of failure. Collect x-rays if available.
  6. Complete Patient Questionnaires:
    • Lysholm Score
    • Tegner Activity Scale
    • KOOS(Knee Injury and Osteoarthritis Outcome Score) Knee Score
  7. If any adverse events, adverse device effects or device deficiencies are observed or reported, they must be recorded
  8. Instruct the subject on follow-up procedures, including returning for Visit 2 in 6 months (-14 Days/+31 Days)

Visit 2 - 12 months post -op.

  1. Query subject regarding any changes in general health and the use of concomitant medications since the last visit
  2. If any adverse events, adverse device effects or device deficiencies are observed or reported, they must be recorded
  3. Complete Lysholm Score, Tegner Activity Scale and KOOS Knee Score
  4. Collect implant disposition information (including review of evidence of implant failure). If a failure has occurred, record details of the cause of failure. Collect x-rays if available
  5. Complete End of Study CRF.

Safety will be evaluated by assessing the frequency and nature of adverse events, serious adverse events and revisions.

Details
Treatment Round XTENDOBUTTON Fixation Device used in suture fixation of ligaments and tendons in conjunction with an ULTRABUTTON™ product or ENDOBUTTON™ device.
Clinical Study IdentifierNCT04211857
SponsorSmith & Nephew, Inc.
Last Modified on29 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 60 yrs?
Gender: Male or Female
Do you have Knee Reconstruction?
Do you have any of these conditions: Do you have Knee Reconstruction??
Do you have any of these conditions: Do you have Knee Reconstruction??
Subject received the Round XTENDOBUTTON for knee repair, 6 months (-14 Days/+31 Days) prior to enrollment
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
Subject is 18 years of age or 60 years of age at the time of surgery

Exclusion Criteria

Subject is entered in another investigational drug, biologic, or device study
Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet