NCT01537146

Brief Summary

The purpose of this study is to elucidate whether patients operated with high tibia open-wedge osteotomy for osteoarthritis of the knee can be treated more appropriately, so that both healing and rehabilitation are served optimally.

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 phase_4

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_4

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

April 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

5.7 years

First QC Date

August 2, 2011

Last Update Submit

January 21, 2016

Conditions

OsteoarthritisMalalignment

Keywords

unicompartmentalosteoarthritisvarusmalalignmentopening wedgeHTOhightibiaosteotomy

Outcome Measures

Primary Outcomes (1)

  • PN morphine consumption

    Use of morphine recorded in medicine journal

    Hours (up to 24 hours)

Secondary Outcomes (4)

  • Pain

    Hours (up to 24 hours)

  • Knee Function

    Months (up to 16 months)

  • General Health Parameters

    Months (up to 16 months)

  • Stability in the osteotomy

    Months (up to 16 months)

Study Arms (2)

Femoral Block

ACTIVE COMPARATOR
Drug: Ropivacaine

Local Infiltration Anagesia

ACTIVE COMPARATOR
Drug: Ropivacaine

Interventions

RopivacaineDRUG

Bolus infusion via catheter/6H for 24H

Also known as: No other names
Femoral Block

Eligibility Criteria

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

You may qualify if:

  • Planned primary open-wedge high tibia osteotomy
  • Patients (male/female) ≥ 18 år
  • Patients giving written informed consent and authority.
  • Patients receiving epidural anaesthesia

You may not qualify if:

  • Patients with intolerance to trial medications
  • Rejection of or contraindicated epidural anaesthesia
  • Patients with rheumatoid arthritis.
  • Patients with Body Mass Index (BMI) ≥ 35
  • Patients that do not read or write Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Orthopaedic Division, Clinik Farsoe, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Anders C Laursen, MD

    Northern Orthopaedic Division, Denmark

    PRINCIPAL INVESTIGATOR

  • Mogens B Laursen, MD, PhD

    Northern Orthopaedic Division, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2011

First Posted

February 23, 2012

Study Start

April 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations

DK(1)