NCT02254499

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

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

September 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

September 29, 2014

Last Update Submit

September 22, 2015

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain intensity on a NRS from 0 to 10 upon ambulation 24 hours following surgery

    24 hours postoperatively

Secondary Outcomes (2)

  • Pain

    48 hours postoperatively

  • Pain

    From day 1 to day 14 following surgery

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with knee osteoarthritis referred for total knee arthroplasty.

You may qualify if:

  • primary unilateral TKA
  • caucasian
  • years
  • osteoarthritis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

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

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 2, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

DK(1)