RecruitingNot Applicable

Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

Italy204 participantsStarted 2022-02-16

Plain-language summary

The aim of the study is to compare the 6 months clinical outcome of the treatment with a single intra-articular collagen injection versus a single placebo (saline solution) infiltration in the infiltrative treatment of knee osteoarthritis. The evaluation will be performed through clinical, subjective and objective assessments.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Unilateral involvement;
✓. Signs and symptoms of degenerative pathology of knee cartilage;
✓. Radiographic and MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);
✓. Failure, defined as the persistence of symptoms, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);
✓. Ability and consent of patients to actively participate in clinical follow-up;

Exclusion criteria

✕. Patients who have undergone intra-articular injections of another substance in the previous 6 months;
✕. Patients undergoing knee surgery within the previous 12 months;
✕. Patients with malignant neoplasms;
✕. Patients with rheumatic diseases;
✕. Patients with diabetes;
✕. Patients with hematologic diseases (coagulopathies);
✕. Patients on anticoagulant therapy;
✕. Patients with metabolic disorders of the thyroid gland;

What they're measuring

KOOS-Pain Score

Timeframe: 6 months follow-up

Trial details

NCT IDNCT04998188

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Roberta Licciardi, Msc

0516366567 roberta.licciardi@ior.it

View on ClinicalTrials.gov More Knee Osteoarthritis trials