EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT

Knee Osteoarthritis Clinical Trial

Official title:

SYMPTOMATIC EFFECTIVENESS OF MICROPARTICLE ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566315
• Other study ID #: 19-AOIP-04
• Secondary ID: 2020-A01447-32
• Status: Completed
• Phase: N/A
• Start date: January 6, 2021
• Est. completion date: September 7, 2022

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 7, 2022
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Arteriography knee arteriography
arteriography and an injection of inert microparticles of 75 µm in neovessels

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Chu de Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee injury self-questionnaire	modification of the pain item in the Knee injury self-questionnaire collected	in the 15 days preceding the procedure
Primary	Knee injury self-questionnaire	modification of the pain item in the Knee injury self-questionnaire collected	at 3 months
Primary	Osteoarthritis Outcome Score (KOOS) self-questionnaire	and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected	in the 15 days preceding the procedure
Primary	Osteoarthritis Outcome Score (KOOS) self-questionnaire	and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected	at 3 months
Secondary	EVA (Analog Visual Scale)	EVA (Analog Visual Scale) score from 0 to 10	in the 15 days preceding the procedure ,
Secondary	EVA (Analog Visual Scale)	EVA (Analog Visual Scale) score from 0 to 10	at 3 months
Secondary	EVA (Analog Visual Scale)	EVA (Analog Visual Scale) score from 0 to 10	at 6 months
Secondary	Osteoarthritis Outcome Score (KOOS) self-questionnaire	KOOS	in the 15 days preceding the procedure,
Secondary	Osteoarthritis Outcome Score (KOOS) self-questionnaire	KOOS	at 3 months,
Secondary	Osteoarthritis Outcome Score (KOOS) self-questionnaire	KOOS	at 6 months,
Secondary	EQ-5D (quality of life scale)	EQ-5D (quality of life scale)	in the 15 days preceding the procedure
Secondary	EQ-5D (quality of life scale)	EQ-5D (quality of life scale)	at 3 months,