Prospective follow-up of clinical efficacy of knee distraction as treatment for knee OA by use of 'ArthroSave's Knee-Reviver'.

Recruiting

Conditions: knee osteoarthritis
10005944

Registration Number: NL-OMON55548

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 70

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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>WOMAC score (pre-treatment vs. follow-up)<br /><br>radiographic joint space width (pre-treatment vs. follow-up)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To document changes in general well-being after Knee Joint Distraction, using<br /><br>ArthroSave*s Knee-Reviver (using SF-36 questionnaire)<br /><br>To document clinical efficacy/ patient satisfaction of subsequent surgical<br /><br>procedures after KJD</p><br>