Clinical trial NCT04211857: Retro-prospective Study of Safety & Performance of Round XTENDOBUTTON™ Fixation Device Post Knee Repair
Official title: A Retro-prospective Follow-up Study of the Safety and Performance of the Round XTENDOBUTTON™ Fixation Device Post Knee Repair in Australian Centres
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Reconstruction
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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.

Detailed 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.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Success of the Round XTENDOBUTTON™ Fixation
timeFrame: 6 months
Secondary outcomes:
measure: Fixation success of the Round XTENDOBUTTON™ at 12 months post operation
timeFrame: 12 months
measure: Lysholm Score
timeFrame: 6 and 12 months
measure: Tegner Activity Scale
timeFrame: 6 & 12 months
measure: KOOS Score (Knee Injury and Osteoarthritis Outcome Score)
timeFrame: 6 & 12 months
measure: Adverse events for the study duration
timeFrame: 12 months
measure: Radiographic evaluation at 6 months
timeFrame: 6 months
measure: Radiographic evaluation at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Frenchs Forest
country: Australia
facility: Peninsula Orthapaedics
Study officials:
affiliation: PORI- Peninsula Orthopedic Research Institute
name: Sam Chia, MBBS, FRACS (Ortho), FAOrthA
role: PRINCIPAL_INVESTIGATOR
References: