Status:
COMPLETED
Long-term Evaluation of Outcomes of Patients Undergoing Autologous Bone Marrow Concentrate Infiltration vs. Hyaluronic Acid
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-75 years
Brief 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 ...
Detailed Description
60 patients treated within the "OA-bi-blind" research protocol from 2016 to 2019 at the II Orthopaedic and Trauma Clinic of the Rizzoli Orthopaedic Institute will be recruited. These are patients unde...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients no longer on call;
- Patients who do not agree to undergo evaluation
- Patients who have passed away.
Key Trial Info
Start Date :
February 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 12 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06164899
Start Date
February 9 2024
End Date
February 12 2025
Last Update
February 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136