Prediction of Pain After Total Knee Arthroplasty | NCT02254499

Studies
Prediction of Pain After Total Knee Arthroplasty

NCT02254499

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Knee Osteoarthritis

Interventions

Not provided

Countries

Denmark

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

Sep 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

Sep 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Sep 29, 2014

First Submission Date that Met QC Criteria

Sep 29, 2014

First Posted Date

Oct 2, 2014Estimated

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

Sep 22, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Name	Class
Lundbeck Foundation	OTHER

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

Despite improvements in treatment, a significant part of patients have severe pain following knee arthroplasty. Preoperative identification of high-risk patients would allow for an intensive individualized analgesic treatment pre- and postoperatively and thus potentially in reduced pain acute and chronically.

Detailed Description

Not provided

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

60Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	Pain intensity on a NRS from 0 to 10 upon ambulation 24 hours following surgery	24 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Pain	Pain intensity on a NRS (numeric rank scale) from 0 to 10 upon ambulation 48 hours following surgery	48 hours postoperatively
Pain	Daily diary reported pain intensity on a NRS (numeric rank scale) from 0 to 10 in average and when worse the first two weeks following knee arthroplasty.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary unilateral TKA
caucasian
50 - 80 years
osteoarthritis

Exclusion Criteria:

deficient written or spoken danish
impairment from psychological og neurological disease
expected discharged to rehabilitation facility
anticoagulant therapy
allergies to analgesic treatment
hypertension (systolic > 160 / diastolic > 100)
ASA class ≥ 4

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with knee osteoarthritis referred for total knee arthroplasty.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gentofte Hospital		Hellerup		2900	Denmark

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