ser-friendliness of *ArthroSave*s Knee-Reviver* compared to *Stryker mono-tubes* in case of knee distraction as treatment for knee osteoarthritis.<br>

Withdrawn

• Conditions: knee osteoarthritis; 10005944

• Registration Number: NL-OMON45556
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>duration needed to place the distraction frame</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>questionnaire regarding user friendliness for the patient</p><br>