Local Infiltration Versus Block Against Pains After High Tibial Osteotomy (HTO_pains)

January 21, 2016 updated by: Northern Orthopaedic Division, Denmark

Examination of the LIA (Local Infiltration) Versus Regional Blockade as Pain Management for Open-wedge High Tibial Osteotomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Axis corrective surgery of the knee is an attractive alternative to the knee prosthesis in young active patients with unilateral osteoarthritis of the knee. The purpose of this study is to elucidate whether patients operated with high tibia open-wedge osteotomy for osteoarthritis of the knee pain can be treated more appropriately, so that both healing and rehabilitation are served optimally.

Proximal open-wedge tibia osteotomy is an accepted treatment option for younger patients with unilateral osteoarthritis of knee. 70 such operations are performed in the investigators Orthopaedic Divisions each year. The surgery involves cutting through the upper end of the tibia and opens the bone using specialized instruments. The tibia is lengthened on the medial side with the purpose of correcting the mechanical axis of the knee joint. The surgery is associated with many pains in the early postoperative phase. Until now, pain treatment has been controlled with either epidural block, or regional block via femoral catheter. Both treatments may involve risks such as loss of strength and sensibility disturbance, which often prolongs the early recovery and mobilization. Moreover, pain treatment administered via femoral catheter is often not sufficient as a part of the area behind the knee joint is not covered.

With the advent of new pain therapies, particularly intra operative administration of local anaesthetics directly in the operating field and catheter administration for postoperative pain management, there is hope that those disadvantages are eliminated. By ensuring an effective pain treatment and the possibility of early mobilization only hours after completion of surgery, this will allow for better patient care in terms of reduced pain, shorter hospitalization and quicker rehabilitation.

New results show that the healing of bone opening is not compromised by rapid mobilization. The migration of bone parts around the opening is measured by roentgen stereometric analysis (RSA), with a precision of approximately 0.2 mm. This verifies stable healing of the bone opening.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Northern Jutland
      • Farsoe, Northern Jutland, Denmark
        • Northern Orthopaedic Division, Clinik Farsoe, Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Femoral Block
Drug: Ropivacaine
Bolus infusion via catheter/6H for 24H
Other Names:
  • No other names
Drug: Ropivacaine
Intra operational bolus infusion. Bolus infusion via catheter /6H for 24H
Other Names:
  • no other names
Active Comparator: Local Infiltration Anagesia
Drug: Ropivacaine
Bolus infusion via catheter/6H for 24H
Other Names:
  • No other names
Drug: Ropivacaine
Intra operational bolus infusion. Bolus infusion via catheter /6H for 24H
Other Names:
  • no other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PN morphine consumption
Time Frame: Hours (up to 24 hours)
Use of morphine recorded in medicine journal
Hours (up to 24 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Hours (up to 24 hours)
Level of pain experienced by the patient, recorded by NRS (numerical rank scale)
Hours (up to 24 hours)
Knee Function
Time Frame: Months (up to 16 months)
Knee function in the patient, measured by KOOS questionnaire
Months (up to 16 months)
General Health Parameters
Time Frame: Months (up to 16 months)
General Health Parameters, measured by EQ-5D questionnaire
Months (up to 16 months)
Stability in the osteotomy
Time Frame: Months (up to 16 months)
Stability in the opening-wedge osteotomy, measured with RSA (Rontgen Stereometric Analysis)
Months (up to 16 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Investigators

  • Principal Investigator: Anders C Laursen, MD, Northern Orthopaedic Division, Denmark
  • Study Chair: Mogens B Laursen, MD, PhD, Northern Orthopaedic Division, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 2, 2011

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ON-04-019-ACL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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