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

May 9, 2023 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MF-AT injection
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
Intra-articular ultrasound-guided injection of MF-AT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 6 months follow-up

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)
Time Frame: baseline, 1 month, 3 months and 12 months follow-up

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)
Time Frame: baseline, 1 month, 3 months, 6 months and 12 months follow-up
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)
Time Frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Stefano Zaffagnini, MD, Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

July 15, 2022

First Posted (Actual)

July 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lipo-Hip

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Osteoarthritis

Clinical Trials on Micro-fragmented adipose tissue injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe