Predicting Poor Outcomes After Primary Knee Arthroplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
Craig Gerrand, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01765699
First received: December 31, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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 Intervention
Osteoarthritis, Knee
Device: Primary knee arthroplasty

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Predicting Poor Outcomes After Primary Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • Change in PROMS [ Time Frame: 1,2,3 and 5 Years post op ] [ Designated as safety issue: No ]

Enrollment: 1300
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Primary knee arthroplasty
Patients with osteoarthritis of the knee undergoing primary knee arthroplasty
Device: Primary knee arthroplasty
Patients undergoing primary knee arthroplasty

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have undergone primary knee arthroplasty in our centre.

Criteria

Inclusion Criteria:

  • Primary knee arthroplasty
  • Osteoarthritis

Exclusion Criteria:

  • No consent for joint registry data collection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765699

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

No publications provided

Responsible Party: Craig Gerrand, Consultant Orthopaedic Surgeon, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01765699     History of Changes
Other Study ID Numbers: 3878
Study First Received: December 31, 2012
Last Updated: January 8, 2013
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on July 22, 2014