Knee OsteoarthritisNCT04566315
EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT
A study testing Arteriography knee arteriography in people with Knee Osteoarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The objective of this study is to evaluate at 3 months in a prospective study, the effectiveness of arterial embolization of neo-vessels in patients with a painful total knee prosthesis despite a well-conducted medical treatment Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Arteriography knee arteriography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2021to 7 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman aged 40 to 80.
- Total knee joint or bilateral Pain with EVA ≥ 50 mm evolving for at least 3 months despite the initiation of a well conducted medical treatment according to current recommendations including analgesics, NSAIDs, rehabilitation and weight loss
Who cannot join
- Minor person.
- Protected adults under the law. Patients deprived of their liberties. Subject not cooperative or unable to meet the requirements of the protocol.
- Subject participating in another clinical trial or in period of exclusion from a previous clinical trial. Severe visceral failure.
- Local infection. Algoneurodystrophy.
- Prosthesis loosening.
- Pregnant or breastfeeding woman.
Show all 13Show fewer
- Allergy to contrast media.
- Chronic or acute renal failure (clearance <30 ml / min).
- Hemostasis disorders (blood platelet count <50,000 / mm3 or patient TCA / control TCA> 1.2 or TP <50%).
- Operative indication for removal of the retained prosthesis.
- Patient with obliterating arterial disease of the lower limbs.
- Contraindication to lidocaine: Known hypersensitivity to lidocaine hydrochloride, to local amide anesthetics or to any of the excipients.
- Patients with recurrent porphyria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SYMPTOMATIC EFFECTIVENESS OF MICROPARTICLE ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT
The objective of this study is to evaluate at 3 months in a prospective study, the effectiveness of arterial embolization of neo-vessels in patients with a painful total knee prosthesis despite a well-conducted medical treatment
Read the detailed description
To date, no study has attempted to measure the effects of arterial embolization on pain in patients with total knee prosthesis. It would be interesting to evaluate, in a therapeutic trial with a good level of evidence, this alternative to drug treatments that are often poorly tolerated, contraindicated or failing in this population of elderly subjects often presenting co-morbidities. This pilot study will be used to calculate the number of patients to be included in a comparative, placebo-controlled, double-blind study. In addition to the evaluation of the undesirable effects of arterial embolization, the objective of this study is to evaluate the effectiveness at 3 and 6 months of embolization of the neovessels on pain, stiffness, physical activity, quality of life and consumption of analgesics and anti-inflammatories.
Evaluation criteria: modification of the pain item in the EVA (Analog Visual Scale), EQ-5D (quality of life scale), and Knee injury and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected in the 15 days preceding the procedure and then at 3 and 6 months ; the use of analgesics and anti-inflammatories; adverse events.
Study population: Patients aged 40 to 80 years with a painful total knee joint. The visual analogue scale (VAS) score must be greater than or equal to 50 mm for at least 3 months optimal medical treatment, and for whom, no surgical retreatment is indicated.
The expected benefits are the improvement of the treatment of patients in therapeutic impasse, wearing a total knee prosthesis whose pain is rebellious and disabling. More generally, the investigators expect an improvement in the quality of life of these patients currently without satisfactory alternative care.
- Conditions
- Knee Osteoarthritis
- Being tested
- Arteriography knee arteriography
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arteriography knee arteriographyProcedure or surgery
arteriography and an injection of inert microparticles of 75 μm in neovessels
| Study group | Role | What they receive |
|---|---|---|
| ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS | Other | SYMPTOMATIC EFFECTIVENESS OF MICROPARTICLE ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT Receives: Procedure: Arteriography knee arteriography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury self-questionnaire
modification of the pain item in the Knee injury self-questionnaire collected
Measured: in the 15 days preceding the procedure
Knee injury self-questionnaire
modification of the pain item in the Knee injury self-questionnaire collected
Measured: at 3 months
Osteoarthritis Outcome Score (KOOS) self-questionnaire
and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected
Measured: in the 15 days preceding the procedure
Osteoarthritis Outcome Score (KOOS) self-questionnaire
and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected
Measured: at 3 months
Secondary outcomes (8)
EVA (Analog Visual Scale)
EVA (Analog Visual Scale) score from 0 to 10
Measured: in the 15 days preceding the procedure ,
EVA (Analog Visual Scale)
EVA (Analog Visual Scale) score from 0 to 10
Measured: at 3 months
EVA (Analog Visual Scale)
EVA (Analog Visual Scale) score from 0 to 10
Measured: at 6 months
Osteoarthritis Outcome Score (KOOS) self-questionnaire
KOOS
Measured: in the 15 days preceding the procedure,
Osteoarthritis Outcome Score (KOOS) self-questionnaire
KOOS
Measured: at 3 months,
Osteoarthritis Outcome Score (KOOS) self-questionnaire
KOOS
Measured: at 6 months,
EQ-5D (quality of life scale)
EQ-5D (quality of life scale)
Measured: in the 15 days preceding the procedure
EQ-5D (quality of life scale)
EQ-5D (quality of life scale)
Measured: at 3 months,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start6 Jan 2021
- Primary completion6 Jul 2021
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Sedat, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566315
- Sponsor's protocol ID
- 19-AOIP-04
- Other IDs
- 2020-A01447-32
- Status last verified
- Jan 2024
- First submitted
- 24 Jul 2020
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYMPTOMATIC EFFECTIVENESS OF MICROPARTICLE ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT
- ClinicalTrials.gov ID
- NCT04566315
- Acronym / sponsor ID
- 19-AOIP-04
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 28 Sep 2020 (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.
The objective of this study is to evaluate at 3 months in a prospective study, the effectiveness of arterial embolization of neo-vessels in patients with a painful total knee prosthesis despite a well-conducted medical treatment
Detailed description
To date, no study has attempted to measure the effects of arterial embolization on pain in patients with total knee prosthesis. It would be interesting to evaluate, in a therapeutic trial with a good level of evidence, this alternative to drug treatments that are often poorly tolerated, contraindicated or failing in this population of elderly subjects often presenting co-morbidities. This pilot study will be used to calculate the number of patients to be included in a comparative, placebo-controlled, double-blind study. In addition to the evaluation of the undesirable effects of arterial embolization, the objective of this study is to evaluate the effectiveness at 3 and 6 months of embolization of the neovessels on pain, stiffness, physical activity, quality of life and consumption of analgesics and anti-inflammatories.
Evaluation criteria: modification of the pain item in the EVA (Analog Visual Scale), EQ-5D (quality of life scale), and Knee injury and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected in the 15 days preceding the procedure and then at 3 and 6 months ; the use of analgesics and anti-inflammatories; adverse events.
Study population: Patients aged 40 to 80 years with a painful total knee joint. The visual analogue scale (VAS) score must be greater than or equal to 50 mm for at least 3 months optimal medical treatment, and for whom, no surgical retreatment is indicated.
The expected benefits are the improvement of the treatment of patients in therapeutic impasse, wearing a total knee prosthesis whose pain is rebellious and disabling. More generally, the investigators expect an improvement in the quality of life of these patients currently without satisfactory alternative care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS | Other | Procedure: Arteriography knee arteriographySYMPTOMATIC EFFECTIVENESS OF MICROPARTICLE ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Man or woman aged 40 to 80.
- Total knee joint or bilateral Pain with EVA ≥ 50 mm evolving for at least 3 months despite the initiation of a well conducted medical treatment according to current recommendations including analgesics, NSAIDs, rehabilitation and weight loss
Key exclusion criteria (13 listed)
- Minor person.
- Protected adults under the law. Patients deprived of their liberties. Subject not cooperative or unable to meet the requirements of the protocol.
- Subject participating in another clinical trial or in period of exclusion from a previous clinical trial. Severe visceral failure.
- Local infection. Algoneurodystrophy.
- Prosthesis loosening.
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 |
|---|---|---|
| Arteriography knee arteriographyarteriography and an injection of inert microparticles of 75 μm in neovessels | Procedure or surgery | ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS |
Primary outcome
Knee injury self-questionnaire
Time frame: in the 15 days preceding the procedure
modification of the pain item in the Knee injury self-questionnaire collected
Knee injury self-questionnaire
Time frame: at 3 months
modification of the pain item in the Knee injury self-questionnaire collected
Osteoarthritis Outcome Score (KOOS) self-questionnaire
Time frame: in the 15 days preceding the procedure
and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected
Osteoarthritis Outcome Score (KOOS) self-questionnaire
Time frame: at 3 months
and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected
8 secondary outcomes
EVA (Analog Visual Scale)
Time frame: in the 15 days preceding the procedure ,
EVA (Analog Visual Scale)
Time frame: at 3 months
EVA (Analog Visual Scale)
Time frame: at 6 months
Osteoarthritis Outcome Score (KOOS) self-questionnaire
Time frame: in the 15 days preceding the procedure,
Osteoarthritis Outcome Score (KOOS) self-questionnaire
Time frame: at 3 months,
Osteoarthritis Outcome Score (KOOS) self-questionnaire
Time frame: at 6 months,
EQ-5D (quality of life scale)
Time frame: in the 15 days preceding the procedure
EQ-5D (quality of life scale)
Time frame: at 3 months,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jacques Sedat, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arteriography knee arteriography in people with Knee Osteoarthritis, 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 12 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury self-questionnaire (time frame: in the 15 days preceding the procedure). The study lists 4 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 12 Jan 2024.