NL-OMON25021
Recruiting
Not Applicable
Prospective follow-up of clinical efficacy of knee distraction as treatment for knee osteoarthritis by use of ‘ArthroSave’s Knee-Reviver’
MC Utrecht0 sites75 target enrollmentTBD
ConditionsKnee osteoarthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee osteoarthritis
- Sponsor
- MC Utrecht
- Enrollment
- 75
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
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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