CompletedNo phase
Long-term Evaluation of Outcomes of Patients Undergoing Autologous Bone Marrow Concentrate Infiltration vs. Hyaluronic Acid
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 60 people enrolled
- Started
- 9 Feb 2024
- Ended
- 12 Feb 2025
- Type of study
- Observational, 2 groups
- Record updated
- 18 February 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- -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
- Who met the following criteria at the time of treatment:
- Male or female patients, aged 18 to 75 years
- Symptomatic bilateral knee osteoarthritis (Kellgren-Lawrence grade 1-4)
- Failure after at least 2 months of conservative treatment
- Ability and consent of patients to actively participate in the rehabilitation protocol and clinic and radiological follow-up; And who meet the following criteria at the time of assessment by telephone or via telemedicine platform
- Capable patients
- Signature of informed consent
- Availability
Who cannot take part
- Patients no longer on call
- Patients who do not agree to undergo evaluation
- Patients who have passed away
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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)
The 2 groups in the trial
- Patients with bilateral knee osteoarthritis treated with hyaluronic acid injection
Patients with bilateral osteoarthritis treated with hyaluronic acid injection treated within the research protocol "OA-bi-blind"
- Patients with bilateral knee osteoarthritis treated with BMAC injection
Patients with bilateral knee osteoarthritis treated with autologous bone marrow concentrate injection treated within the research protocol "OA-bi-blind"
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Long-term Evaluation of Outcomes of Patients Undergoing Autologous Bone Marrow Concentrate Infiltration vs. Hyaluronic Acid for the Treatment of Bilateral Knee Osteoarthritis. Prospective Observational Study
- Record updated
- 18 February 2025