Functional outcome and painrelief in patients with osteoarthritis of the knee due to oral intake of UC II (undenaturated collagen Typ II):A multicenter, prospective, randomised, placebo controlled clinical trial

Phase 4

• Conditions: M17.1; Other primary gonarthrosis

• Registration Number: DRKS00028473
• Lead Sponsor: Orthopädie im MediaparkMediaPark Klinik Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Sufficiently severe gonarthrosis grade II and III according to the nativradiological criteria according to Kellgren/Lawrence or magnetic resonance imaging criteria according to Outerbridge.

Diagnosis confirmed by standard X-ray (AP, lateral, patella tangential, Rosenberg, whole leg) or MRI

Age: 50-70 years

VAS 3-7

Gender: both

Exclusion Criteria

Exclusion criteria (knee-related)
- Arthrofibrosis
- Extension deficit (<20°)
- Flexion deficit (> 100°)
- Insufficiency of the anterior and/or posterior cruciate ligament
- Intra-articular injections with corticosteroid, hyaluronic acid and PRP in the last 3 months
- Chronic use of medication with effect on the joint (e.g. corticoid)

Exclusion criteria (not knee related)
- Insufficient German language skills
- Immunological diseases / autoimmune diseases / rheumatic disease
- Age < 50 years; age > 70 years
- BMI > 35
- Neurological diseases (e.g. Parkinson's disease, self-reported)
- Major other lower extremity injuries / surgeries (e.g.
insufficient cruciate ligaments)
- Leg axis deviation > 15° (varus or valgus)
- Breastfeeding or pregnant women
- Dementia
- Severe psychological disorder(s)
- Alcohol abuse
- Disseminated malignancy
- Severe systemic disease
- Hyperuricemia
- Acute local or septic infection

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS)

Secondary Outcome Measures

Name	Time	Method
Pain assessment using Visual Analog Scale (VAS)<br><br>Amount of emergency medication used (ibuprofen 400mg)