Comparing collagen injection to placebo for knee osteoarthritis
Hydrolyzed Collagen Formulation Versus Placebo in the Treatment of Degenerative Knee Cartilage Injuries
This study is testing if a single injection of collagen can help people with knee osteoarthritis feel better compared to a placebo shot.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT04998188 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a single intra-articular injection of hydrolyzed collagen compared to a placebo (saline solution) in patients with knee osteoarthritis. A total of 204 participants will be randomly assigned to receive either the collagen injection or the placebo, with follow-up assessments conducted at 1, 3, and 6 months post-injection. Clinical evaluations will include both subjective questionnaires and objective measures such as thermographic assessments to monitor inflammation. After 6 months, participants in the placebo group will have the option to switch to the collagen treatment for an additional 6 months of follow-up.
Who should consider this trial
Good fit: Ideal candidates are individuals with unilateral knee osteoarthritis who have not responded to conservative treatments.
Not a fit: Patients with recent knee surgeries, other significant medical conditions, or those who have received other intra-articular injections in the past 6 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing knee osteoarthritis symptoms.
How similar studies have performed: While similar approaches have been explored, this specific formulation and method of administration is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Alessandro Di Martino, MD — Istituto Ortopedico Rizzoli
- Study coordinator: Roberta Licciardi, Msc
- Email: roberta.licciardi@ior.it
- Phone: 0516366567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.