Northern Orthopaedic Division, Clinik Farsoe, Aalborg University Hospital
Farsø, Northern Jutland, Denmark
NCT Number: NCT01537146
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Farsø, Northern Jutland, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bolus infusion via catheter/6H for 24H
Other names: No other names
Time frame: Hours (up to 24 hours)
Use of morphine recorded in medicine journal
Time frame: Hours (up to 24 hours)
Level of pain experienced by the patient, recorded by NRS (numerical rank scale)
Time frame: Months (up to 16 months)
Knee function in the patient, measured by KOOS questionnaire
Time frame: Months (up to 16 months)
General Health Parameters, measured by EQ-5D questionnaire
Time frame: Months (up to 16 months)
Stability in the opening-wedge osteotomy, measured with RSA (Rontgen Stereometric Analysis)
Northern Orthopaedic Division, Denmark
Other
Examination of the LIA (Local Infiltration) Versus Regional Blockade as Pain Management for Open-wedge High Tibial Osteotomy
Acronym: HTO_pains
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