Clinical trial NCT06164899: Long-term Evaluation of Outcomes of Patients Undergoing Autologous Bone Marrow Concentrate Infiltration vs. Hyaluronic Acid
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: hyaluronic acid injection
BMAC injection
Bone Marrow aspirate concentrate
long term follow-up
Prospective observational study
Hyalorunic acid
knee joint
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing infiltration 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

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 the treatment of bilateral knee osteoarthritis: Autologous bone marrow concentrate VS. hyaluronic acid)

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (IKDC)-Subjective Knee Evaluation Form
timeFrame: baseline
measure: Knee Injury and Osteoarthritis Outcome score- (KOOS Score)
timeFrame: baseline
measure: EuroQol Visual Analogue Scale (EQ-VAS )
timeFrame: baseline
measure: Tegner Score
timeFrame: baseline
measure: EQ-5D (EuroQoL) Current Health Assessment
timeFrame: baseline
measure: Patient Acceptable Symptom State (PASS)
timeFrame: baseline
measure: Visual Analogue Scale (VAS)
timeFrame: baseline
measure: Final treatment opinion
timeFrame: baseline
measure: Failure
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
name: Stefano Zaffagnini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boffa A, Di Martino A, Andriolo L, De Filippis R, Poggi A, Kon E, Zaffagnini S, Filardo G. Bone marrow aspirate concentrate injections provide similar results versus viscosupplementation up to 24 months of follow-up in patients with symptomatic knee osteoarthritis. A randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2022 Dec;30(12):3958-3967. doi: 10.1007/s00167-021-06793-4. Epub 2021 Nov 12.
citation: Cavallo C, Boffa A, Andriolo L, Silva S, Grigolo B, Zaffagnini S, Filardo G. Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. Int Orthop. 2021 Feb;45(2):525-538. doi: 10.1007/s00264-020-04703-w. Epub 2020 Jul 13.
citation: Filardo G, Madry H, Jelic M, Roffi A, Cucchiarini M, Kon E. Mesenchymal stem cells for the treatment of cartilage lesions: from preclinical findings to clinical application in orthopaedics. Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1717-29. doi: 10.1007/s00167-012-2329-3. Epub 2013 Jan 11.
citation: Fortier LA, Strauss EJ, Shepard DO, Becktell L, Kennedy JG. Biological Effects of Bone Marrow Concentrate in Knee Pathologies. J Knee Surg. 2019 Jan;32(1):2-8. doi: 10.1055/s-0038-1676069. Epub 2018 Nov 30.
citation: Trigkilidas D, Anand A. The effectiveness of hyaluronic acid intra-articular injections in managing osteoarthritic knee pain. Ann R Coll Surg Engl. 2013 Nov;95(8):545-51. doi: 10.1308/rcsann.2013.95.8.545.