CompletedNot Applicable

Long-term Evaluation of Outcomes of Patients Undergoing Autologous Bone Marrow Concentrate Infiltration vs. Hyaluronic Acid

Italy60 participantsStarted 2024-02-09

Plain-language summary

This is a prospective observational study for long-term clinical evaluation (minimum 4-year follow-up) in patients treated within the research protocol "OA-bi-blind" (Double-blind randomized trial on the treatment of bilateral knee osteoarthritis: Autologous bone marrow concentrate VS. hyaluronic acid)

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓Patients undergoing injection for the treatment of bilateral gonarthrosis of autologous bone marrow concentrate vs. hyaluronic acid within the OA-bi-Blind Research protocol at the II Orthopedic and Trauma Clinic of the Rizzoli Orthopedic Institute.

What they're measuring

Knee Injury and Osteoarthritis Outcome Score (IKDC)-Subjective Knee Evaluation Form

Timeframe: baseline

Knee Injury and Osteoarthritis Outcome score- (KOOS Score)

Timeframe: baseline

EuroQol Visual Analogue Scale (EQ-VAS )

Timeframe: baseline

Tegner Score

Timeframe: baseline

EQ-5D (EuroQoL) Current Health Assessment

Timeframe: baseline

Patient Acceptable Symptom State (PASS)

Timeframe: baseline

Visual Analogue Scale (VAS)

Timeframe: baseline

Final treatment opinion

Timeframe: baseline

Failure

Trial details

NCT IDNCT06164899

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-02-12

View on ClinicalTrials.gov More Knee Osteoarthritis trials