Treatment of Osteoarthritis of the Hip Joint With Intra-articular Injection of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hip Osteoarthritis, Hip Disease

Intervention / Treatment
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* Procedure: Micro-fragmented adipose tissue injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 40 and 70 years; 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); 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. Unilateral involvement; Ability and consent of patients to actively participate in clinical follow-up; Signature of informed consent. Exclusion Criteria: Patients unable to express consent; Patients undergoing infiltration of other substance in the previous 6 months; Patients undergoing lower limb surgery to be treated in the previous 12 months; Patients with malignant neoplasms; Patients with rheumatic diseases; Patients with uncontrolled diabetes; Patients with uncontrolled thyroid metabolic disorders; Patients abusing alcoholic beverages, drugs or medications; Body Mass Index > 35; Pregnant and/or fertile women. Pain intensity less than 4 points or greater than 8 in accordance with the VAS scale. 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. Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Interventional pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MF-AT injection<br>Patients will be treated with an intra-articular-ultrasound-guided injection of Micro-fragmented adipose tissue containing mesenchymal stromal cells. | Procedure: Micro-fragmented adipose tissue injection<br>* Intra-articular ultrasound-guided injection of MF-AT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome | 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome | baseline, 1 month, 3 months and 12 months follow-up | 
| Visual Analogue Scale (VAS) | VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to no pain and the strongest pain imaginable. | baseline, 1 month, 3 months, 6 months and 12 months follow-up | 
| Harris Hip Scale (HHS) | This scale was developed for the evaluation of hip surgery outcomes and is intended to assess various hip disabilities and treatment methods in an adult population. The four sections that make up the questionnaire are: pain, function, absence of deformity, and range of motion. The HHS is a measure of dysfunction, so higher is the score, better is the outcome for the individual. The maximum possible score is 100. | baseline, 1 month, 3 months, 6 and 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MF-AT, MF-AT injection, Mesenchymal stromal cells, Pilot study, Hip, Micro-fragmented Adipose Tissue