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10003 PRO Current Products

NCT01497730 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 842

Last updated 2019-04-22

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • DePuy Orthopaedics

    lead INDUSTRY

Principal Investigators

  • Ahmad S. Ismail, MS, CCRP · DePuy Orthopaedics

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-01
Primary Completion
2018-08-10
Completion
2018-08-10

Countries

  • United States
  • Australia
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01497730 on ClinicalTrials.gov