Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

Last updated: October 21, 2024
Sponsor: Istituto Ortopedico Rizzoli
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Knee Injuries

Treatment

Collagen

Placebo (saline solution)

Clinical Study ID

NCT04998188
COLL-OA
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Unilateral involvement;

  2. Signs and symptoms of degenerative pathology of knee cartilage;

  3. Radiographic and MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);

  4. Failure, defined as the persistence of symptoms, after at least one course ofconservative treatment (pharmacological, physiotherapeutic or infiltrativetreatment);

  5. Ability and consent of patients to actively participate in clinical follow-up;

Exclusion

Exclusion Criteria:

  1. Patients who have undergone intra-articular injections of another substance in theprevious 6 months;

  2. Patients undergoing knee surgery within the previous 12 months;

  3. Patients with malignant neoplasms;

  4. Patients with rheumatic diseases;

  5. Patients with diabetes;

  6. Patients with hematologic diseases (coagulopathies);

  7. Patients on anticoagulant therapy;

  8. Patients with metabolic disorders of the thyroid gland;

  9. Patients abusing alcoholic beverages, drugs or medications;

  10. Body Mass Index > 35;

  11. Pregnant or lactating women.

  12. Patients with established hypersensitivity to bovine collagen or vitamin C.

  13. Patients with joint or peri-articular infections, emarto, erythema, or psoriaticpatches in the knee joint area

Study Design

Total Participants: 204
Treatment Group(s): 2
Primary Treatment: Collagen
Phase:
Study Start date:
February 16, 2022
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Istituto Ortopedico Rizzoli

    Bologna, 40136
    Italy

    Active - Recruiting

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