NCT03032133

Brief Summary

Patients are randomized to receive pain control after Total Knee Arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and mobility is asessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable knee-osteoarthritis

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

February 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

January 24, 2017

Last Update Submit

February 11, 2019

Conditions

Knee Osteoarthritis

Keywords

Total Knee ArthroplastyTotal Knee ReplacementOutcomeResultsPain

Outcome Measures

Primary Outcomes (1)

  • pain

    Pain on Visual Analog Scale

    daily until day 7 after surgery

Secondary Outcomes (5)

  • analgetics

    daily until day 7 after surgery

  • Mobility

    daily until day 7 after surgery

  • Function

    preoperative, 3 month, 1 year

  • Patient reported outcome

    preoperative, 3 month, 1 year

  • Quality of Life

    preoperative, 3 month, 1 year

Study Arms (2)

Regional pain control

ACTIVE COMPARATOR

Regional pain catheter

Procedure: Regional pain control

Local pain control

EXPERIMENTAL

Local intraarticular pain catheter

Procedure: Local pain control

Interventions

Regional pain controlPROCEDURE

Regional pain catheter

Regional pain control
Local pain controlPROCEDURE

Local intraarticular pain catheter

Local pain control

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication to Total Knee Arthroplasty
  • Signed informed consent

You may not qualify if:

  • Chronic pain
  • Allergy against local anaesthetics
  • Not understanding study or questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jörg Lützner, MD

    TU Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 26, 2017

Study Start

February 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

February 12, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)