14022 ATTUNE Cementless RP Clinical Performance Evaluation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Osteoarthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Masking Description: An independent radiographic reviewer will be assessing all radiographs from the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 22 years and 80 years
- Gender
- Both males and females
Description
The secondary objectives of this study are: Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L. Evaluate change from preoperative baseline in pain ...
The secondary objectives of this study are: Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L. Evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale) at 2yr. Evaluate type and frequency of Adverse Events Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR RP and PS RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs. Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery. Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.
Tracking Information
- NCT #
- NCT02839850
- Collaborators
- Not Provided
- Investigators
- Study Director: Verdonna Huey, MS Sponsor GmbH
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