NL-OMON55548
Recruiting
Not Applicable
Prospective follow-up of clinical efficacy of knee distraction as treatment for knee OA by use of 'ArthroSave's Knee-Reviver'. - Prospective follow-up of 'ArthroSave's Knee-Reviver'.
niversitair Medisch Centrum Utrecht0 sites70 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- knee osteoarthritis
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 70
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
- •\- 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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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