Local Infiltration Versus Block Against Pains After High Tibial Osteotomy (HTO_pains)
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 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|
- PN morphine consumption [ Time Frame: Hours (up to 24 hours) ] [ Designated as safety issue: No ]Use of morphine recorded in medicine journal
- 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)
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Femoral Block||
Bolus infusion via catheter/6H for 24H
Other Name: No other names
|Active Comparator: Local Infiltration Anagesia||
Intra operational bolus infusion. Bolus infusion via catheter /6H for 24H
Other Name: no other names
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537146
|Northern Orthopaedic Division, Clinik Farsoe, Aalborg University Hospital|
|Farsoe, Northern Jutland, Denmark|
|Principal Investigator:||Anders C Laursen, MD||Northern Orthopaedic Division, Denmark|
|Study Chair:||Mogens B Laursen, MD, PhD||Northern Orthopaedic Division, Denmark|