|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P150030 / PAS001 |
| Date Original Protocol Accepted |
10/17/2016
|
| Date Current Protocol Accepted |
08/21/2020
|
| Study Name |
Long-Term F/u of EU patients PAS
|
| Device Name |
R3 DELTA CERAMIC HIP SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, multicenter, observational study that is currently in the follow-up data collection phase. Five of the seven study sites that contributed data to the PMA cohort will participate in this PAS.
|
| Study Population |
All subjects in the investigational group of the PMA Cohort excluding one patient who died and one patient who was revised.
|
| Sample Size |
A total of 135 subjects will be followed.
|
| Key Study Endpoints |
The primary endpoint is implant survivorship at 10 years post study procedure.
Secondary endpoints include the following:
Patient outcomes as measured using the modified Harris Hip Score;
Radiographic evaluation to assess radiographic success defined as:
No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones; and
No femoral or acetabular subsidence greater than or equal to 5mm from baseline; and
No acetabular cup inclination changes greater than 4 degrees (4°)
|
| Follow-up Visits and Length of Follow-up |
Patients will be followed for 10 years.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
135 hips
|
| Actual Number of Sites Enrolled |
5 sites
|
| Patient Follow-up Rate |
The 10-year follow-up rate for subjects with all primary and secondary endpoints data is 78.6% (99/126).
|
| Final Safety Findings |
A total of 130 hips had adverse event data by 10 years of follow-up. There were 14 device-related adverse events (AEs) in 6.2% (8/130) of hips. At 10-year follow-up, 1.5% (2/130) of patients were revised for loosening (one hip was revised for cup loosening failure and one hip was revised for stem loosening failure). There were 24 procedure- related AEs that occurred in 14.6% (19/130) of the hips. The most frequently reported device- and procedure-related AEs were pain, hip discomfort, soreness, and heterotopic ossification.
|
| Final Effect Findings |
Survivorship: At 10-years post-surgery, Kaplan-Meier implant survivorship is estimated as 0.98 (95% Confidence interval: 0.950, 1.000).
Functional Outcomes: At 10-years of follow up, 89.7% (105/117) of patients were reported to have ‘Excellent’ or ‘Good’ modified Harris Hip Score (mHHS) (score >80) and 3.4% (4/117) were reported to have ‘Poor’ mHHS (score 60-69). Radiographic Outcomes: At 10-years post-surgery, radiographic success was reported 95.1% (97/102).
|
| Study Strengths & Weaknesses |
Strength: The study was able to demonstrate long-term device safety and effectiveness through 10 years post-surgery. Weaknesses: The loss to follow-up and missing data (e.g., radiographic, mHHS, and AEs). The results may not be generalizable to US patients or practice (OUS study population).
|
| Recommendations for Labeling Changes |
Yes, a labeling change is recommended to update the device labeling with the final study results. Labeling update can identify the impact of protocol deviations including those resulting from COVID-19 (e.g., partial data collection or missing data on device safety and effectiveness).
|
