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The 12 month post-operative study is designed to provide safety and performance data on the Round XTENDOBUTTONâ„¢ fixation device after knee repair.
This is a retro-prospective 12 month follow-up study of the safety and performance of the Round XTENDOBUTTONâ„¢ fixation device post knee repair in Australian centres.
The Primary Objective is to assess successful fixation with the Round XTENDOBUTTONâ„¢ and the Secondary Objective is to generate safety and performance evidence for the Round XTENDOBUTTONâ„¢ Device via the collection of functional outcomes, patient reported outcomes and safety data.
Forty subjects will be enrolled; who have had the round XTENDOBUTTONâ„¢ 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 XTENDOBUTTONâ„¢ 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 XTENDOBUTTONâ„¢ device at the study site.
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 -----
Assign the subject a Subject ID number and instruct the subject on treatment procedures
Complete Screening and Enrollment Log
Obtain demographic information and medical history, including information on all relevant concomitant medications
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.
Complete Patient Questionnaires:
If any adverse events, adverse device effects or device deficiencies are observed or reported, they must be recorded
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.
Safety will be evaluated by assessing the frequency and nature of adverse events, serious adverse events and revisions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Round XTENDOBUTTON Fixation Device used in suture fixation of ligaments and tendons in conjunction with an ULTRABUTTONâ„¢ product or ENDOBUTTONâ„¢ device. | Device | Round XTENDOBUTTON Fixation Device used in suture fixation of ligaments and tendons in conjunction with an ULTRABUTTONâ„¢ product or ENDOBUTTONâ„¢ device. |
| Measure | Description | Time Frame |
|---|---|---|
| Success of the Round XTENDOBUTTONâ„¢ Fixation | The fixation success at 6 months post knee operation with the XTENDOBUTTONâ„¢ 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fixation success of the Round XTENDOBUTTONâ„¢ at 12 months post operation | Fixation success of the Round XTENDOBUTTONâ„¢ 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Sam Chia, MBBS, FRACS (Ortho), FAOrthA | PORI- Peninsula Orthopedic Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peninsula Orthapaedics | Frenchs Forest | 2086 | Australia |
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| 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 | 6 and 12 months |
| 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. | 6 & 12 months |
| 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. | 6 & 12 months |
| Adverse events for the study duration | 12 months |
| 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. | 6 months |
| 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. | 12 months |