Arthroscopic Debridement Followed by Intra-articular Injection of Micro-fragmented Adipose Tissue in Patients Affected by Knee Osteoarthritis

NCT06545266 | Completed

• 1 other identifier: 2219
• Study Type: observational
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background/Objectives: Micro-fragmented adipose tissue is emerging as a promising option for the treatment of various diseases including knee osteoarthritis (OA), though clinical trials are often limited by small sample size and short follow-up periods. Our aim was to evaluate safety and clinical outcomes of an arthroscopic debridement followed by a single injection of micro- fragmented adipose tissue in patients affected by knee OA. Methods: From 2016 to 2020 patients affected by knee OA were enrolled. Micro-fragmented adipose tissue was obtained through the Lipogems kit and intraarticularly injected after an arthroscopic debridement. VAS for pain, Tegner score, Lysholm score, KOOS score subscales variations were assessed from baseline to 3-, 6-, 12-, 24- and 48 months follow-up.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale for pain (VAS)

  3-, 6-,12-, 24- and 48 months follow-up.

Secondary Outcomes (3)

• Tegner score

  3-, 6-,12-, 24- and 48 months follow-up.

• Knee Injury & Osteoarthritis Outcome (KOOS) score

  3-, 6-,12-, 24- and 48 months follow-up.

• Failure rate

  3-, 6-,12-, 24- and 48 months follow-up.

Interventions

micro-fragmented adipose tissue injection PROCEDURE

Micro-fragmented adipose tissue was obtained through the Lipogems kit and intraarticularly injected after an arthroscopic debridement.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged \> 18 years, affected by radiologically confirmed knee OA according to Kellgren-Lawrence classification, not responsive to at least 3 months of conservative treatment (e.g. physical therapy, exercise).

You may qualify if:

• age \> 18 years, patients affected by radiologically confirmed knee OA according to Kellgren-Lawrence classification, not responsive to at least 3 months of conservative treatment (e.g. physical therapy, exercise).

You may not qualify if:

• recent traumatic events involving the index joint, chondromatosis, intra-articular injections of any type in the previous 6 months, malignancy, pregnancy, patients on anticoagulant therapy or suffering from coagulopathies and related disorders, systematic disorders affecting the joints (i.e rheumatoid arthritis). Enrolled patients underwent a knee radiograph (antero-posterior, Rosenberg and lateral projections) as well as MRI before the procedure to stage knee OA and evaluate potential intra-articular loose bodies or diseases different from knee OA (e.g tumors or focal cartilage lesions).

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Related Publications (1)

• Bruno AAM, Anzillotti G, De Donato M, Basso M, Tamini J, Dupplicato P, Kon E, Di Matteo B, Arnaldi E. Arthroscopic debridement followed by intra-articular injection of micro-fragmented adipose tissue in patients affected by knee osteoarthritis: Clinical results up to 48 months from a prospective clinical study. J Exp Orthop. 2025 Jan 17;12(1):e70144. doi: 10.1002/jeo2.70144. eCollection 2025 Jan.

  PMID: 39830171 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

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

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 9, 2024
• Study Start: January 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share