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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

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 - OIUC2

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028473
Enrollment
202
Registered
2022-03-09
Start date
2022-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M17.1

Interventions

Group 1: Oral delivery of 40mg Undenatured Collagen Type II (UC II) per day. Group 2: Placebo Control

Sponsors

Orthopädie im MediaparkMediaPark Klinik Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

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: Exclusion criteria (knee-related) - Arthrofibrosis - Extension 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 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

Design outcomes

Primary

MeasureTime frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)

Secondary

MeasureTime frame
Pain assessment using Visual Analog Scale (VAS) Amount of emergency medication used (ibuprofen 400mg)

Countries

Germany

Contacts

Public ContactPaul Klein

Orthopädie im Mediapark MediaPark Klinik Köln

paulklein@t-online.de+49 221 97 97 455

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026