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NCT01497730 · ClinicalTrials.gov registry record
10003 PRO Current Products
A clinical trial, sponsored by DePuy Orthopaedics.
- Completed
- Registry status
- 842
- Enrollment target
NCT01497730: Completed study, sponsored by DePuy Orthopaedics.
NCT01497730 is a clinical trial that has completed, run by DePuy Orthopaedics. The registered enrollment target is 842 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01497730 has completed, sponsored by DePuy Orthopaedics.
- COMPLETED
- Registry status
- 842 participants
- Enrollment target
Study Summary
This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations from different manufacturers will be pooled to establish a contemporary dataset. The primary objective of this study is to evaluate the functional performance as measured by the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score (KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year post-operation. This will be carried out for all four implant configurations. The final endpoint is a 2-year evaluation.
Primary Outcome
The primary endpoint will be measuerd before surgery and out to a minimum of 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. The KOOS consists of 5 subscales; pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee-related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subsc
Interventions
- DEVICE Total Knee Replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 842 participants |
| Start Date | 2011-10-01 |
| Est. Completion | 2018-08-10 |
What the finished NCT01497730 record still lists
NCT01497730 is an observational study that tracks outcomes without assigning an intervention. The registered 842 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Total Knee Replacement is the first listed.
NCT01497730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01497730 about?
NCT01497730 is a clinical study titled "10003 PRO Current Products". This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations from different manufacturers will be pooled to establish a contemporary da...
What is the current status of trial NCT01497730?
This trial is currently completed. The enrollment target is 842 participants. The study started on 2011-10-01. Estimated completion is 2018-08-10.
What interventions are being tested in trial NCT01497730?
The interventions under investigation include: Total Knee Replacement (DEVICE).
Who is sponsoring clinical trial NCT01497730?
This trial is sponsored by DePuy Orthopaedics, which has 38 total clinical trials registered on ClinicalTrials.gov.
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