NCT05955976

Brief Summary

Over the last few years, it has been suggested that Knee Ostheoarthritis (KOA) incidence and progression could potentially be related to skeletal muscle characteristics. In particular, weakness of the quadriceps muscle would be a key determinant of KOA. However the mechanisms underpinning the influence of skeletal muscle in the pathophysiology of ostheoarthritis (OA) are poorly understood. Crosstalk between skeletal muscle and structures around and in the joint is of interest. In physical deconditioning and aging, it has been reported that skeletal muscle can be replaced by adipose tissue. Several factors involved in the development of OA but also of adipose tissue may be involved in these muscular changes. Of interest, in patients with KOA, quadriceps weakness is an ubiquitous clinical finding. Infiltration of adipose tissue in skeletal muscle has been shown to affect muscle strength and mobility and be linked to cartilage volume loss and the occurrence/progression of KOA. The main objective of this study is to compare the characteristics of the Hoffa tissus and the intamuscular fat (IMF) tissus in the quadriceps muscle in patients with gonarthrosis requiring total knee prosthesis. This is a single-centre study based on a collection of surgical waste and is categorized as Research Not Involving Human subjects.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

July 13, 2023

Last Update Submit

July 24, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps): adipose tissue size differences

    size mesured in mm

    4 months

  • Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps): lipid levels

    level mesured in %

    4 months

  • Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps):fibrotic tissue

    rate mesured in %

    4 months

Study Arms (1)

Patients suffering of knee ostheoarthritis undergoing a surgery for a total knee prosthesis.

Other: BIOPSY

Interventions

BIOPSYOTHER

biopsy

Patients suffering of knee ostheoarthritis undergoing a surgery for a total knee prosthesis.

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged between 40 and 85 years that have a scheduled surgery for a total knee prosthesis and have a confirmed diagnosis of knee ostheoarthritis.

You may qualify if:

  • Adult patient, aged between 40 and 85 years
  • Patient having a confirmed diagnosis of knee ostheoarthritis
  • Patient undergoing a surgery for a total knee prosthesis for knee ostheoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice University Hospital

Nice, 06000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Hoffa tissue (1 cm x 1 cm) and intramuscular fat tissue (1 cm x 1 cm)

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Christian ROUX, PUPH

CONTACT

Jean-François GONCALVEZ, PUPH

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

July 20, 2023

Primary Completion

September 20, 2023

Study Completion

March 20, 2024

Last Updated

July 25, 2023

Record last verified: 2023-07

Locations