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

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Knee Osteoarthritis

Study type: Observational

Funder types: Other

Identifiers

NCT06164899

OA-bi Blind LT

Details and patient eligibility

About

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)

Full 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 undergoing infiltration for the treatment of bilateral gonarthrosis of autologous bone marrow concentrate vs. hyaluronic acid within the OA-bi-Blind Research protocol.Prior to enrollment, patients will be contacted provided they have released their personal or legal guardian's e-mail address and/or personal or legal guardian's telephone number in advance and only after verifying the patient's consent to be contacted again for research purposes. If the patient is interested in participating in the study, arrangements will be made with him or her to send the Informed Consent and Disclosure Letter.

The patient will have to return (by means of a pre-stamped envelope that he will have received together with the consent itself) the Informed Consent completed in all its parts to the address given in the information letter. Only upon obtaining the fully completed Informed Consent may the investigator subject the patient to a telephone interview.

Alternatively, the patient may receive the Informed Consent and the questionnaire for clinical evaluations digitally.Clinical score data will be collected from the questionnaires conducted at long-term follow-up of patients enrolled in the study. The data collected during the long-term follow-up, will be used to evaluate the time course of outcomes after treatment with autologous bone marrow concentrate versus hyaluronic acid in patients who received either treatment as per the ''OA-bi-blind'' protocol.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

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 criteria

• Patients no longer on call;
• Patients who do not agree to undergo evaluation
• Patients who have passed away.

Trial design

60 participants in 2 patient groups

Patients with bilateral knee osteoarthritis treated with hyaluronic acid injection

Description:

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

Description:

Patients with bilateral knee osteoarthritis treated with autologous bone marrow concentrate injection treated within the research protocol "OA-bi-blind"