Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance (10003)
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | December 20, 2011 | ||||
Last Updated Date | June 1, 2012 | ||||
Start Date ICMJE | October 2011 | ||||
Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score [ Time Frame: up to one year ] [ Designated as safety issue: No ] 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 subscale. |
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01497730 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance | ||||
Official Title ICMJE | Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance | ||||
Brief 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. |
||||
Detailed Description | The study is designed as a prospective, single arm stratified, multi-center investigation. Approximately 20 study sites, worldwide, will enroll 840 patients (840 knees). Each study site is expected to enroll approximately 42 patients (42 knees). Cohort reallocation is permitted. There will be no control group. Eight hundred forty (840) Subjects will be stratified into 4 subgroups of 210: fixed bearing cruciate retaining (FB CR), fixed bearing posterior stabilized (FB PS), rotating platform cruciate retaining (RP CR), and rotating platform posterior stabilized (RP PS). Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
Condition ICMJE | Noninflammatory Degenerative Joint Disease | ||||
Intervention ICMJE | Device: Total Knee Replacement
Subjects will receive one of the following total knee implants: PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices. |
||||
Study Arm (s) | Experimental: Total Knee Replacement
Subjects will receive one of the following total knee implants:
Intervention: Device: Total Knee Replacement |
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 840 | ||||
Estimated Completion Date | October 2014 | ||||
Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 22 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
|
||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01497730 | ||||
Other Study ID Numbers ICMJE | 10003 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | DePuy Orthopaedics | ||||
Study Sponsor ICMJE | DePuy Orthopaedics | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | DePuy Orthopaedics | ||||
Verification Date | March 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |