Trial document




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  DRKS00028473

Trial Description

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Title

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

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Trial Acronym

OIUC2

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URL of the Trial

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Brief Summary in Lay Language

Study to investigate the efficacy of the dietary supplement UC II (Undenatured Collagen Type II) in osteoarthritis patients.

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Brief Summary in Scientific Language

Prospective, randomized, blinded, placebo-controlled, clinical trial to evaluate the outcome in terms of pain and function by peroral intake of the nutritional supplement UC II versus placebo. Functional outcome will be assessed using KOOS scores (Knee and Osteoarthritis Outcome Score) and VAS (Visual Analog Scale).

The dietary supplement UC II (Undenatured Collagen Type II) is approved as such and is already on the market in different dosage forms as a monopreparation or as an addition to other dietary supplements.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

The data sharing violates agreements made with the financial supporter of the study.

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Organizational Data

  •   DRKS00028473
  •   2022/03/09
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  •   yes
  •   Approved
  •   196/2021, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   M17.1 -  Other primary gonarthrosis
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Interventions/Observational Groups

  •   Oral delivery of 40mg Undenatured Collagen Type II (UC II) per day.
  •   Placebo Control
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

Knee Injury and Osteoarthritis Outcome Score (KOOS)

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Secondary Outcome

Pain assessment using Visual Analog Scale (VAS)

Amount of emergency medication used (ibuprofen 400mg)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
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Recruitment

  •   Planned
  •   2022/04/01
  •   202
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   70   Years
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Additional 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

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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

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Addresses

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    • Orthopädie im MediaparkMediaPark Klinik Köln
    • Im MediaPark 3
    • 50670  Köln
    • Germany
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    • Orthopädie im MediaparkMediaPark Klinik Köln
    • Mr.  Dr.  Paul  Klein 
    • Im MediaPark 3
    • 50670  Köln
    • Germany
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    • Orthopädie im Mediapark MediaPark Klinik Köln
    • Mr.  Dr.  Paul  Klein 
    • Im MediaPark 3
    • 50670  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Lonza Ltd.
    • Muenchensteinerstrasse 38
    • CH-4002  Basel
    • Switzerland
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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