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Predicting Poor Outcomes After Primary Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01765699
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

Aim To identify through data analysis key patients, surgeon and operative dependent variables which will improve the performance of knee replacement for primary osteoarthritis

Research Question

  1. Can the investigators identify association between outcomes and patients characteristics using existing (already collected) datasets
  2. What are the characteristics of patients with poor outcome after knee replacement
  3. What can be done to improve the outcome of patients at risk of poor results

Condition or disease Intervention/treatment
Osteoarthritis, Knee Device: Primary knee arthroplasty

Detailed Description:
This is a retrospective analysis of a prospectively collected single centre database.

Study Design

Study Type : Observational
Actual Enrollment : 1300 participants
Time Perspective: Retrospective
Official Title: Predicting Poor Outcomes After Primary Knee Arthroplasty
Study Start Date : February 2012
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Primary knee arthroplasty
Patients with osteoarthritis of the knee undergoing primary knee arthroplasty
Device: Primary knee arthroplasty
Patients undergoing primary knee arthroplasty

Outcome Measures

Primary Outcome Measures :
  1. Change in PROMS [ Time Frame: 1,2,3 and 5 Years post op ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone primary knee arthroplasty in our centre.

Inclusion Criteria:

  • Primary knee arthroplasty
  • Osteoarthritis

Exclusion Criteria:

  • No consent for joint registry data collection
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765699

Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
DePuy Orthopaedics
Principal Investigator: Craig Gerrand Consultant Orthopaedic Surgeon
Study Director: David Deehan Consultant Orthopaedic Surgeon
More Information

Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01765699     History of Changes
Other Study ID Numbers: 3878
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases