Prospective follow-up of clinical efficacy of knee distraction as treatment for knee osteoarthritis by use of ‘ArthroSave’s Knee-Reviver’
- Conditions
- Knee osteoarthritis
- Registration Number
- NL-OMON25021
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
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) (with 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; 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method WOMAC score and radiographic joint space width evaluated by KIDA software
- Secondary Outcome Measures
Name Time Method SF36 questionnaire for general wellbeing