'User-friendly' knee distraction for treatment of osteoarthritis compared to conventional 'proof-of-concept' knee distraction treatment

Withdrawn

Conditions: knee osteoarthritis
10023213

Registration Number: NL-OMON43216

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

Patients with severe knee osteoarthritis (persisting conventional treatment resistant pain and cartilage tissue damage) considered for total (or uni) knee arthroplasty or high tibial osteotomy (with limited axis deviation), in general practice by the orthopaedic surgeon offered knee joint distraction as alternative treatment.
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) (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 (e.g. pain syndroms); 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>A: surgery time needed to place the knee joint distractor<br /><br>B: clinical efficacy by KOOS/WOMAC questionaire based on pain, function and<br /><br>stifness after 2 years</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A: convienence/burden of wearing the device for 6-7 weeks of the knee<br /><br>distractor (questionnaire)<br /><br>B: joint space width (cartilage thickness) on radiographs after 2 years </p><br>