Grip on knee Osteoarthritis; DIstraction Versus Arthroplasty (GODIVA) for young knee osteoarthritis patients in regular care.

Recruiting

Conditions: arthrosis
osteoarthritis
10023213

Registration Number: NL-OMON54110

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1200

Inclusion Criteria

- Clinical diagnosis of knee OA
- Age <= 65 years and >= 18 years
- Persistent, refractory pain, insufficiently responding to conservative and
previous non-surgical therapy
- Structural OA joint damage, indicated by a K&L grade of at least 2
- Able to wear an external fixator and care for it for 6 weeks
- Accepting that the maximal effect of KJD is not present directly after
removal of the frame but may take months after frame removal
- Sufficient joint stability (according to the orthopedic surgeon*s judgement)
- Flexion (>100 degrees) and extension range (<10 degrees)
- Weight and BMI <120 kg and <35 kg/m2 respectively

Exclusion Criteria

- Surgical intervention in last 6 months
- Leg-axis deviation > 10 degrees
- Serious osteopenia making placing bone-pins and wearing a frame into a risk
(according to the orthopedic surgeon*s judgement)
- Coagulation problems making occurrence of thrombosis or embolies into a risk
(according to the orthopedic surgeon*s judgement)
- Existing endoprosthesis at another joint (i.e., hip or contralateral knee) to
prevent infection of existing prosthesis
- History or presence of joint infection/inflammation
- Hypersensitivity to antibiotics
- Presence of systemic inflammatory disease, like rheumatoid arthritis
For the substudy: Inability to undergo a knee-MRI or knee-CT and DEXA according
to the local enforced criteria in regular health care.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: Western Ontario and McMaster Universities Arthritis Index<br /><br>(WOMAC) total score.<br /><br>For the substudy: MRI, CT, DEXA image markers and blood and urine biochemical<br /><br>markers</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Main secondary outcomes: WOMAC/KOOS Pain, stiffness, and physical function<br /><br>sub-scores, quality of life (EQ-5D, SF-36), radiographic joint space width (KJD<br /><br>only); adverse events, and productivity and healthcare cost. All assessed over<br /><br>24 months.</p><br>