NCT04998188 Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
| NCT ID | NCT04998188 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2022-02-16 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2022-02-16 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment); 5. Ability and consent of patients to actively participate in clinical follow-up; Exclusion Criteria: 1. Patients who have undergone intra-articular injections of another substance in the previous 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 psoriatic patches in the knee joint area
Contact & Investigator
Alessandro Di Martino, MD
PRINCIPAL INVESTIGATOR
Istituto Ortopedico Rizzoli
Frequently Asked Questions
Who can join the NCT04998188 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04998188 currently recruiting?
Yes, NCT04998188 is actively recruiting participants. Contact the research team at roberta.licciardi@ior.it for enrollment information.
Where is the NCT04998188 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT04998188 clinical trial?
NCT04998188 is sponsored by Istituto Ortopedico Rizzoli. The principal investigator is Alessandro Di Martino, MD at Istituto Ortopedico Rizzoli. The trial plans to enroll 204 participants.