'User-friendly' knee distraction for treatment of osteoarthritis compared to conventional 'proof-of-concept' knee distraction treatment - User-friendly knee distraction

niversitair Medisch Centrum Utrecht0 个研究点目标入组 90 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Patients with severe knee osteoarthritis (persisting conventional treatment resistant pain and cartilage tissue damage) considered for total (or uni) knee arthroplasty or high tibial osteotomy (with limited axis deviation), in general practice by the orthopaedic surgeon offered knee joint distraction as alternative treatment.
•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•- adults *65 years of age (at higher ages cost-benefit is becoming less; 15)
•- BMI < 35 kg/m2 (mechanical safety limit of device) (max 110 kg body weight)
•- Normal-good physical condition (arbitrary defined by orthopaedic surgeons)
•- Sufficient knee joint stability (arbitrary defined by orthopaedic surgeons)
•- Sufficient range of motion (arbitrary defined by orthopaedic surgeons)
•- Radiographic signs of joint damage (KL grade 2-4)
•- VAS (visual analogue scale) pain >40/100 (conservative treatment resistant)

•General: Patients that would not be considered for arthroplasty or osteotomy because of psychosocial condition (e.g. pain syndroms); or who meet any of the following criteria will be excluded from participation in this study:
•- Comorbidities that would compromise the efficacy of knee joint distraction (arbitrary defined by orthopaedic surgeons)
•- History of inflammatory or septic arthritis
•- Knee mal-alignment of more than 10 degrees
•- Previous surgical interventions of the index knee < 6 months ago
•- Absence of any joint space width on both sides (medial and lateral) of X-ray
•- presence of an endo-prostheses elsewhere

发起方

niversitair Medisch Centrum Utrecht