Prospective follow-up of clinical efficacy of knee distraction as treatment for knee osteoarthritis by use of ‘ArthroSave’s Knee-Reviver’

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25021

Enrollment

Registered

2019-08-30

Start date

2017-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Interventions

None listed

Eligibility

Inclusion 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 40/100 (conservative treatment resistant)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
WOMAC score and radiographic joint space width evaluated by KIDA software	—

Secondary

Measure	Time frame
SF36 questionnaire for general wellbeing	—

Contacts

Public ContactA.C.A. Marijnissen

UMC Utrecht

a.c.a.marijnissen@umcutrecht.nl+31887550459

Outcome results