Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions

NCT06078072 | Completed

• 1 other identifier: University Medical Centre
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries; Cartilage Injury; Osteochondral Defect

Keywords

Biomaterials; Mesenchymal stem/stromal cells; Bone marrow aspirate; Cartilage; Osteochondral lesion; Knee

Outcome Measures

Primary Outcomes (1)

• Knee injury and Osteoarthritis Outcome Score (KOOS) subscale Pain postoperative improvement

  Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patients' pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score 0 being the worst score and 100 indicating no impairment. KOOS subscale Pain postoperative improvement will be calculated as difference between preoperative and postoperative scores at the final follow up. Paired Student t test will be applied to compare preoperative and postoperative values of KOOS subscale Pain.

  At least 24 months after the operation

Secondary Outcomes (7)

• Knee injury and Osteoarthritis Outcome Score (KOOS) subscales postoperative improvements

  At least 24 months after the operation

• Complications (SAE and GF)

  Recording until the final follow up (minimum 24 months after the operation)

• Cellular parameters of intraoperatively applied filtered Bone Marrow Aspirate (fBMA)

  Finsihed in 14 days after the procedure

• Tegner Activity Scale (TAS) postoperative improvement

  At least 24 months after the operation

• European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) postoperative improvement

  At least 24 months after the operation

Interventions

Biomaterials augmented with mesenchymal stem/stromal cells PROCEDURE

Combined single-step procedure of treating knee articular surface lesions with biomaterials (scaffolds) and mesenchymal stem cells (filtered bone marrow aspirate concentrate)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University medical centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Kolar M, Veber M, Girandon L, Drobnic M. A Biomimetic Osteochondral Scaffold Augmented With Filtered Bone Marrow Aspirate for the Treatment of Joint Surface Lesions in the Knee. Am J Sports Med. 2024 Jun;52(7):1826-1833. doi: 10.1177/03635465241247788. Epub 2024 May 20.

  PMID: 38767159 DERIVED

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Matic Kolar, MD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: October 11, 2023
• Study Start: September 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-10

Locations

SL (1)