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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01537146
First received: August 2, 2011
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Malalignment
Drug: Ropivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examination of the LIA (Local Infiltration) Versus Regional Blockade as Pain Management for Open-wedge High Tibial Osteotomy

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • PN morphine consumption [ Time Frame: Hours (up to 24 hours) ] [ Designated as safety issue: No ]
    Use of morphine recorded in medicine journal


Secondary Outcome Measures:
  • Pain [ Time Frame: Hours (up to 24 hours) ] [ Designated as safety issue: No ]
    Level of pain experienced by the patient, recorded by NRS (numerical rank scale)

  • Knee Function [ Time Frame: Months (up to 16 months) ] [ Designated as safety issue: No ]
    Knee function in the patient, measured by KOOS questionnaire

  • General Health Parameters [ Time Frame: Months (up to 16 months) ] [ Designated as safety issue: No ]
    General Health Parameters, measured by EQ-5D questionnaire

  • Stability in the osteotomy [ Time Frame: Months (up to 16 months) ] [ Designated as safety issue: No ]
    Stability in the opening-wedge osteotomy, measured with RSA (Rontgen Stereometric Analysis)


Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Femoral Block Drug: Ropivacaine
Bolus infusion via catheter/6H for 24H
Other Name: No other names
Active Comparator: Local Infiltration Anagesia Drug: Ropivacaine
Intra operational bolus infusion. Bolus infusion via catheter /6H for 24H
Other Name: no other names

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537146

Locations
Denmark
Northern Orthopaedic Division, Clinik Farsoe, Aalborg University Hospital
Farsoe, Northern Jutland, Denmark
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01537146     History of Changes
Other Study ID Numbers: ON-04-019-ACL
Study First Received: August 2, 2011
Last Updated: September 12, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
unicompartmental
osteoarthritis
varus
malalignment
opening wedge
HTO
high
tibia
osteotomy

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014