Clinical trial NCT05465096: Treatment of Osteoarthritis of the Hip Joint With Intra-articular Injection of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells.
Official title: Interventional Pilot Study on the Treatment of Osteoarthritis of the Hip Joint With Intra-articular Ultrasound-guided Infiltration of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Hip Disease
Keywords: MF-AT
MF-AT injection
Mesenchymal stromal cells
Pilot study
Hip
Micro-fragmented Adipose Tissue
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional pilot study
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the safety and efficacy up to 12 months of MF-AT in the echo-guided infiltrative treatment of hip OA through clinical, subjective and objective evaluations.

Detailed description: For this pilot study, will be enrolled 30 patients with OA of the hip. All patients will be treated with a single infiltration of MF-AT obtained by the Lipogems® method. All activities of the present trial will be carried out at the Rizzoli Orthopaedic Institute (selection and enrollment, abdominal sampling, infiltrative treatment and follow-ups).

Patients will undergo infiltrative treatment after collecting informed consent for study participation and biographical data. Thereafter, patients will be followed up with clinical evaluation at 1-3-6-12 months follow-up.

Eligibility criteria: Inclusion Criteria:

1. Age between 40 and 70 years;
2. Signs and symptoms of hip OA (pain intensity of at least 4 points and not more than 8 of VAS pain - 0-10 scale in the previous week);
3. Radiographic signs of hip OA (Grade 1-2 according to Tonnis classification) or MRI signs (chondropathy or minimal labrum degeneration without acute lesions) even if Grade 0.
4. Unilateral involvement;
5. Ability and consent of patients to actively participate in clinical follow-up;
6. Signature of informed consent.

Exclusion Criteria:

1. Patients unable to express consent;
2. Patients undergoing infiltration of other substance in the previous 6 months;
3. Patients undergoing lower limb surgery to be treated in the previous 12 months;
4. Patients with malignant neoplasms;
5. Patients with rheumatic diseases;
6. Patients with uncontrolled diabetes;
7. Patients with uncontrolled thyroid metabolic disorders;
8. Patients abusing alcoholic beverages, drugs or medications;
9. Body Mass Index \> 35;
10. Pregnant and/or fertile women.
11. Pain intensity less than 4 points or greater than 8 in accordance with the VAS scale.
12. Patients with other hip pathologies: acetabular protrusion, concentric migration of the femoral head, presence of excessive deformity resulting from acetabular or femoral head dysplasia, collapse deformity, and deformed femoral head sequelae of Perthes disease or osteonecrosis of the femoral head.
13. Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict).

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: baseline, 1 month, 3 months and 12 months follow-up
measure: Visual Analogue Scale (VAS)
timeFrame: baseline, 1 month, 3 months, 6 months and 12 months follow-up
measure: Harris Hip Scale (HHS)
timeFrame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Stefano Zaffagnini, MD
role: PRINCIPAL_INVESTIGATOR
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