Osteo Arthritis KneeADIPENIGMENCT05955976
Characteristics of Hoffa Adipose Tissue and Intramuscular Adipose Tissue in the Quadriceps Muscle
An observational study of Osteo Arthritis Knee, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- BIOPSY
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2023to 20 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nice University Hospital
Nice, 06000
Christian Roux, 0492035491, roux.c2@chu-nice.fr
Christian ROUX
About this study
Official title: Study to Compare the Characteristics of Hoffa Adipose Tissue and Intramuscular Adipose Tissue in the Quadriceps Muscle
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.
Read more
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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- BIOPSY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOPSYOther
biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering of knee ostheoarthritis undergoing a surgery for a total knee prosthesis. | Not described Receives: Other: BIOPSY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps): adipose tissue size differences
size mesured in mm
Measured: 4 months
Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps): lipid levels
level mesured in %
Measured: 4 months
Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps):fibrotic tissue
rate mesured in %
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start20 Jul 2023
- Primary completion20 Sep 2023
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955976
- Sponsor's protocol ID
- 23Rhumato02
- Acronym
- ADIPENIGME
- Status last verified
- Jun 2026
- First submitted
- 13 Jul 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Compare the Characteristics of Hoffa Adipose Tissue and Intramuscular Adipose Tissue in the Quadriceps Muscle
- ClinicalTrials.gov ID
- NCT05955976
- Acronym / sponsor ID
- ADIPENIGME / 23Rhumato02
- Conditions
- Osteo Arthritis Knee
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering of knee ostheoarthritis undergoing a surgery for a total knee prosthesis. | – | Other: BIOPSY |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOPSYbiopsy | Other | Patients suffering of knee ostheoarthritis undergoing a surgery for a total knee prosthesis. |
Primary outcome
Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps): adipose tissue size differences
Time frame: 4 months
size mesured in mm
Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps): lipid levels
Time frame: 4 months
level mesured in %
Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps):fibrotic tissue
Time frame: 4 months
rate mesured in %
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis Knee, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian ROUX, PUPH (0492035491, roux.c2@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps): adipose tissue size differences (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.