Clinical trial NCT06078072: Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions
Official title: Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Injuries
Cartilage Injury
Osteochondral Defect
Keywords: Biomaterials
Mesenchymal stem/stromal cells
Bone marrow aspirate
Cartilage
Osteochondral lesion
Knee
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100-150 adult patients (age:18-65) with knee articular surface lesions (size ≥ 1.5 cm2, ICRS grades 3-4) surgically treated with the combined single-step approach (scaffold and fBMA) between January 2013 and December 2020.

Brief summary: The goal of this observational study is to evaluate the combined single-step approach with biomaterials and mesenchymal stem/stromal cells in the treatment of knee articular surface lesions. The clinical analysis of the treatment outcomes, regarding postoperative improvements and safety, is going to be accompanied with laboratory analysis of the intraoperatively applied cellular products.

The main hypothesis are: (1) such combined single-step procedure significantly improves patients' functioning and quality of life; (2) this therapeutic approach is safe; (3) cellular parameters of the applied filtered bone marrow aspirate (fBMA) impact treatment outcomes, among other potential predictors.

Researchers will compare subjective (questionnaire) and objective (clinical examination) status of patients before and after the operation, record any potential complications and perform regression analysis to assess the influence of potential predictors on postoperative improvements.


Eligibility criteria: Inclusion Criteria:

* informed consent
* patients treated with combined single-step procedure (scaffold and fBMA) for knee articular surface lesions, between January 2013 and December 2020
* symptomatic knee articular surface lesions (International cartilage repair society (ICRS) grades 3-4, size ≥ 1.5 cm2) unresponsive to conservative treatment,
* only mild concomitant osteoarthritis (Kellgren-Lawrence grades 1-2)

Exclusion Criteria:

* patients that refuse to participate in the study
* non responders to the invitation to answer PROMs at the follow-up
* associated medical conditions (inflammatory, metabolic, neoplastic, etc.) that could directly handicap the musculoskeletal system or indirectly impact the quality of life

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) subscale Pain postoperative improvement
timeFrame: At least 24 months after the operation
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) subscales postoperative improvements
timeFrame: At least 24 months after the operation
measure: Complications (SAE and GF)
timeFrame: Recording until the final follow up (minimum 24 months after the operation)
measure: Cellular parameters of intraoperatively applied filtered Bone Marrow Aspirate (fBMA)
timeFrame: Finsihed in 14 days after the procedure
measure: Tegner Activity Scale (TAS) postoperative improvement
timeFrame: At least 24 months after the operation
measure: European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) postoperative improvement
timeFrame: At least 24 months after the operation
measure: EuroQol Visual Analogue Scale (EQ-VAS) postoperative improvement
timeFrame: At least 24 months after the operation
measure: Potential predictors (patients' demographics, medical history, joint and lesions' characteristics, surgical and cellular parameters) of the clinical outcomes (KOOS subscales, EQ-5D-3L, EQ-VAS, TAS)
timeFrame: At the time of statistical analysis
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University medical centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Matic Kolar, MD
role: PRINCIPAL_INVESTIGATOR
References: