|
|
| General |
| Study Status |
Ongoing |
| 522 Number / Requirement Number |
PS230002 / PSS001 |
| Date Original Plan Accepted |
07/28/2023
|
| Date Current Plan Accepted |
03/12/2024
|
| Study Name |
MISHA Post-Market Clinical Study
|
| Device Name |
Misha knee system
|
| Root Document Number |
DEN220033
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Study Design: The MISHA Post-Market Study is a prospective, single-arm, observational, multicenter, post-market clinical study.
Study Objective(s): Prospective evaluation of the safety and effectiveness of the MISHA Knee System. The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions (SSIs), BMI levels, range of motion (ROM), UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post- procedure. This study will assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years. Study subjects will be followed over a five-year post-implant period.
|
| Study Population |
The subject population for this study will include male or female subjects aged 25 to 65 years, with a diagnosis of medial knee osteoarthritis and study knee pain with an overall WOMAC pain score greater than or equal to 40 (scale 0 -100).
A Diversity Plan will also be followed for the post-market study to support inclusion of a diverse patient population with respect to age, sex, ethnicity, and race.
|
| Sample Size |
Number of subjects: 120 subjects
Number of sites: Up to 10 US sites
|
| Key Study Endpoints |
Primary Endpoint: Freedom from device- and procedure -related subsequent surgical interventions (SSIs) at 5 years post-implantation.
Secondary Endpoints
5 – Year WOMAC Pain and Function
Percent of subjects meeting clinically meaningful improvement of WOMAC Pain at 5 years (defined as greater than or equal to 10 – point change from baseline
Percent of subjects meeting clinically meaningful improvement of WOMAC Function at 5 years (defined as greater than or equal to 10 – point change from baseline
Additional Observations
The following procedural and long-term assessments will be measured at post-op (within 6
weeks), 3 months, 6 months, and annually through 5 years.
WOMAC pain questions derived from the KOOS Knee questionnaire
WOMAC function questions derived from the KOOS Knee questionnaire
KSS subject satisfaction
UCLA activity score
Range of motion (ROM)
Radiographic assessments (Implant Integrity)
Subsequent surgical interventions by type of surgical intervention (revision, removal, re-operation, supplemental fixation, conversion to arthroplasty, other intervention)
AEs by type over time and relatedness. AEs will be tabulated and summarized as counts and percentages. AEs will also be cross tabulated according to
-Unanticipated Adverse Device Effect (UADE);
-Serious Adverse Event (SAE)
-Device _ Relatedness
-Procedure – Relatedness
The study will continue to collect data on subjects who have the device removed to determine if they maintain the benefits post-removal. AEs and WOMAC pain & function scores will be compared for removal subjects and subjects that still have the device implanted. A sub-analysis will be performed among high-risk subgroups including subjects with high BMI and subjects with high levels of activity.
|
| Follow-up Visits and Length of Follow-up |
All subjects included in this study will return for follow-up visits within six (6) weeks post-index procedure and at three (3), six (6) and twelve (12) months, then annually through five (5) years.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
2
|
| Actual Number of Sites Enrolled |
2
|
| Patient Followup Rate |
N/A. The study has not progressed far enough to provide this information.
|
| Final Safety Findings |
One adverse event
|
| Final Effectiveness Findings |
N/A. The study has not progressed far enough to obtain findings.
|
