Trial document

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DRKS-ID: 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?

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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

DRKS-ID: DRKS00028473
Date of Registration in DRKS: 2022/03/09
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 196/2021, Ethik-Kommission der Universität Witten/Herdecke

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Secondary IDs

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Health Condition or Problem studied

ICD10: M17.1 - Other primary gonarthrosis

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Interventions/Observational Groups

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

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject, investigator/therapist, caregiver, data analyst
Control: Placebo
Purpose: Treatment
Assignment: Parallel
Phase: IV
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

Doctor's Practice Köln
Doctor's Practice Nürnberg
Medical Center Charité - Universitätsmedizin Berlin Abteilung Sportmedizin, Berlin
Doctor's Practice Mühster
Doctor's Practice Hamburg
Doctor's Practice Frankfurt a.M.
Doctor's Practice Darmstadt
Doctor's Practice Darmstadt
Doctor's Practice Pforzheim
Medical Center ATOS Klinik Stuttgart Orthopädie/Unfallchirurgie, Stuttgart

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Recruitment

Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2022/04/01
Target Sample Size: 202
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 50 Years
Maximum Age: 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

Primary Sponsor
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- Orthopädie im MediaparkMediaPark Klinik Köln
- Im MediaPark 3
- 50670 Köln
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: https://atos-kliniken.com/de/mediapark-koeln/
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Contact for Scientific Queries
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- Orthopädie im MediaparkMediaPark Klinik Köln
- Mr. Dr. Paul Klein
- Im MediaPark 3
- 50670 Köln
- Germany
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- Telephone: +49 221 97 97 455
- Fax: [---]*
- E-mail: paulklein at t-online.de
- URL: [---]*
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Contact for Public Queries
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- Orthopädie im Mediapark MediaPark Klinik Köln
- Mr. Dr. Paul Klein
- Im MediaPark 3
- 50670 Köln
- Germany
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- Telephone: +49 221 97 97 455
- Fax: [---]*
- E-mail: paulklein at t-online.de
- URL: [---]*
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Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- Lonza Ltd.
- Muenchensteinerstrasse 38
- CH-4002 Basel
- Switzerland
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting planned
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): [---]*
Number of Participants in Germany after Recruiting complete: [---]*
Total Number of Participants (all Sites worldwide) after Recruiting complete: [---]*

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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.