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Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis

Efficacy of Intra-articular Injection of Combined Hyaluronic Acid and Platelet-rich Plasma in Knee Degenerative Joint Disease

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03211650
Enrollment
174
Registered
2017-07-07
Start date
2016-10-14
Completion date
2021-03-27
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

The purpose of this study is to evaluate the efficacy of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain.

Interventions

DRUGhyaluronic Acid + platelet-rich plasma

Intra-articular injections of hyaluronic acid combined with platelet-rich plasma

DRUGhyaluronic acid

Intra-articular injections of hyaluronic acid

DRUGplatelet-rich plasma

Intra-articular injections of platelet-rich plasma

Sponsors

Regen Lab SA
CollaboratorINDUSTRY
University of Milan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Knee pain for 4 months; * Knee degenerative sign evaluated with X-ray with a Kellgren-Lawrence grade inferior to 3; * Patients able to understand the study conditions and willing to participate for its entire duration; * Patients who signed written informed consent.

Exclusion criteria

* Severe knee osteoarthritis of grade 4; * Diabetes mellitus; * Rheumatoid arthritis; * Ongoing malignancies; * Certified allergic reactions towards the administered drugs ; * Malalignment of mechanical axis of the lower limb (varus \> 10 °, valgus \> 10 °); * Coagulopathies; * Severe cardiovascular diseases; * Ongoing infections; * Immunodepression; * Anticoagulants or anti-platelet agents; * Haemoglobin \< 11 g/dl; * Platelet count \< 150,000/mm\^3 * Drug addiction; * Alcoholism; * Psychiatric disease; * Pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frameDescription
WOMAC score6 months after the first intra-articular injectionComparison of WOMAC total score among three treatment arms

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026