Hydrolyzed Collagen Formulation Versus Placebo in the Treatment of Degenerative Knee Cartilage Injuries

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    Istituto Ortopedico Rizzoli
Updated on 16 October 2022
conservative management


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.


204 patients affected by knee osteoarthritis will be included in a double-blinded randomized controlled trial. Patients in the experimental group will be treated with a single intra-articular injection of collagen (solution of low molecular weight peptides derived from hydrolyzed collagen) instead patients in the control arm, will be treated with a single intra-articular injection of placebo (saline solution). All patients will be evaluated by clinical examination before the infiltrative procedure and they will follow-up at 1,3,6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment and questionnaires, filled out by patients, will be utilized for clinical evaluations. After 6 months, patients in the control arm (saline solution injection), have the possibility to cross-over into the treatment arm (collagen) in which case they will be followed for an additional 6 months.

Condition Knee Osteoarthritis
Treatment Placebo (saline solution), Collagen
Clinical Study IdentifierNCT04998188
SponsorIstituto Ortopedico Rizzoli
Last Modified on16 October 2022


Yes No Not Sure

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
Patients abusing alcoholic beverages, drugs or medications
Body Mass Index > 35
Pregnant or lactating women
Patients with established hypersensitivity to bovine collagen or vitamin C
Patients with joint or peri-articular infections, emarto, erythema, or psoriatic patches in the knee joint area
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