Characteristics of Marrow Fatty Cells in the Ageing of Bone and Joints, Osteoarthritis and Osteoporosis

NCT03678831 | Completed

• 2 other identifiers: 2017_592018-A00660-55
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity and other associated complications promote the development and the progression of osteoarthritis. The subcutaneous and abdominal fat release several factors that alter bone and the cartilage. The role of the marrow fat in close connection with bone has not been defined yet, whereas cellular and animal models indicate that this fat depot modifies bone and cartilage. The aim of the study is to define if the marrow fat produces more joint-altering factors by comparison with subcutaneous fat. This fat depot can be characterized from removed pieces during the prosthetic surgery of the knee. Measuring before surgery the body weight, waist and hip circumferences, blood pressure, glucose, insulin and lipids in blood will also allow to determine if obesity and/or type 2 diabetes make this fat more dangerous for the joint. Such research will allow the elaboration of new therapeutic strategies in osteoarthritis.

Conditions

Osteoarthritis, Knee; Prosthesis User

Keywords

Osteoarthritis; prosthetic surgery of the knee; obesity; type 2 diabetes; bone marrow fat

Outcome Measures

Primary Outcomes (1)

• Expression levels in femoral spinal adipocytes of mRNAs of 18 genes compared to those of adipocytes isolated from the subcutaneous adipose tissue in the same patient

  at 3 months

Secondary Outcomes (5)

• the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Obesity state (normal vs overweight vs obese) as defined using BMI

  at 3 months

• the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Central obesity (yes or no) as defined using the waist-to-hip ratio

  at 3 months

• the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Presence or absence of systemic insulin-resistance as measured using the HOMA-IR index

  at 3 months

• the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytesaccording to Presence or absence of chronic uncontrolled hyperglycaemia as measured using HbA1c plasma levels

  at 3 months

• the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to presence or absence of metabolic syndrome

  at 3 months

Study Arms (1)

Arthritic patients with knee prosthetic replace

Arthritic post-menopausal patients with knee prosthetic replacement Each patient is her own control since the two cell types are compared within the same patient The main criteria is based on a comparison of two cell types from the same patient. The secondary criteria are based on a comparison of cell types according to a grouping of patients according to different metabolic parameters.

Procedure: tissue

Interventions

tissue PROCEDURE

Adipocyte isolation from distal femoral epiphysis and subcutaneous adipose tissue at the surgery site; classical piece removal during prosthetic replacement of the knee

Arthritic patients with knee prosthetic replace

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Arthritic post-menopausal patients with knee prosthetic replacement

You may qualify if:

• Post-menopausal woman
• with a symptomatic knee osteoarthritis requiring prosthesis
• able to handle general anaesthesia
• having given her consent
• able to understand the constraints associated with the study
• with health insurance
• able to understand the French language

You may not qualify if:

• with refusal to participate to the study
• more than 85-year-old
• with bone pathologies other than osteoarthritis or osteoporosis
• with active infection
• with evolving cancer
• with haematopoietic pathologies such as haemoglobin pathologies
• with thyroid pathologies
• with type 1 diabetes
• with anti-osteoporotic treatments (bisphosphonates, strontium ranelate, teriparatide, denosumab) except calcium and vitamin D supplementation or hormone replacement.
• with replacement of prosthesis
• with previous surgery at the surgery site
• with a current participation to another study
• with guardianship
• with deprived liberty

Sponsors & Collaborators

• University Hospital, Lille: lead
• MSDAVENIR Foundation: collaborator

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Obesity; Diabetes Mellitus, Type 2

Interventions

Histocompatibility Testing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Gilles Pasquier, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 20, 2018
• Study Start: June 30, 2020
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

FR (1)