NCT01179204

Brief Summary

In this consecutive, prospective cohort study trial the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

1.1 years

First QC Date

August 9, 2010

Last Update Submit

September 25, 2012

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Cumulated pain (from 0-24 hours after surgery)

    Pain during walk 5 m (VAS)

    24 hours

Secondary Outcomes (3)

  • Cumulated pain (from day 1 to day 7 after surgery)

    7 days

  • Pain at day 14 after surgery

    14 days

  • Pain at day 30 after surgery

    30 days

Study Arms (1)

Patiens operated with TKA

Procedure: Preoperative heat stimulation

Interventions

Preoperative heat stimulationPROCEDURE

Preoperative short and long tonic heat stimulation

Patiens operated with TKA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients operated with total knee arthroplasty (TKA)

You may qualify if:

  • Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total knee arthroplasty.

You may not qualify if:

  • Bilateral / revision arthroplasty
  • Disease affection central or peripheral nerve function
  • Alcohol and medical abuse
  • Daily use of opioids or glucocorticoids
  • Malignancy
  • BMI \> 40
  • Depression
  • Dementia or other cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood-samples

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Troels H. Lunn, M.D

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 11, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

DK(1)