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Clinical Trials/NL-OMON25021
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

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
MC Utrecht

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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