Predicting Poor Outcomes After Primary Knee Arthroplasty | NCT01765699

Studies
Predicting Poor Outcomes After Primary Knee Arthroplasty

NCT01765699

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Status

Completed

Last Update Posted

Oct 12, 2015Estimated

Enrollment

1,300Actual

Phase

Not provided

Conditions

Osteoarthritis, Knee

Interventions

Primary knee arthroplasty

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Dec 31, 2012

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2015

Last Update Posted Date

Oct 12, 2015Estimated

Name	Class
DePuy Orthopaedics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Primary knee arthroplasty		Patients with osteoarthritis of the knee undergoing primary knee arthroplasty	Device: Primary knee arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Primary knee arthroplasty	Device	Patients undergoing primary knee arthroplasty	Primary knee arthroplasty

Measure	Description	Time Frame
Change in PROMS		1,2,3 and 5 Years post op

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary knee arthroplasty
Osteoarthritis

Exclusion Criteria:

No consent for joint registry data collection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who have undergone primary knee arthroplasty in our centre.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Craig Gerrand	Consultant Orthopaedic Surgeon	Principal Investigator
David Deehan	Consultant Orthopaedic Surgeon	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided