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

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Arteriography knee arteriography

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacques Sedat, MD; Phone Number: 0492033807; Email: sedat.j@chu-nice.fr

Study Locations

• France
  • Chu de Nice
    • Nice, Chu de Nice, France, 06003
      • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS; SYMPTOMATIC EFFECTIVENESS OF MICROPARTICLE ARTERIAL EMBOLIZATION IN PATIENTS WITH TOTAL KNEE PROSTHESIS WITH PAIN RESISTANT TO MEDICAL TREATMENT	Procedure: Arteriography knee arteriography; arteriography and an injection of inert microparticles of 75 μm in neovessels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee injury self-questionnaire	modification of the pain item in the Knee injury self-questionnaire collected	in the 15 days preceding the procedure
Knee injury self-questionnaire	modification of the pain item in the Knee injury self-questionnaire collected	at 3 months
Osteoarthritis Outcome Score (KOOS) self-questionnaire	and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected	in the 15 days preceding the procedure
Osteoarthritis Outcome Score (KOOS) self-questionnaire	and Osteoarthritis Outcome Score (KOOS) self-questionnaire collected	at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EVA (Analog Visual Scale)	EVA (Analog Visual Scale) score from 0 to 10	in the 15 days preceding the procedure ,
EVA (Analog Visual Scale)	EVA (Analog Visual Scale) score from 0 to 10	at 3 months
EVA (Analog Visual Scale)	EVA (Analog Visual Scale) score from 0 to 10	at 6 months
Osteoarthritis Outcome Score (KOOS) self-questionnaire	KOOS	in the 15 days preceding the procedure,
Osteoarthritis Outcome Score (KOOS) self-questionnaire	KOOS	at 3 months,
Osteoarthritis Outcome Score (KOOS) self-questionnaire	KOOS	at 6 months,
EQ-5D (quality of life scale)	EQ-5D (quality of life scale)	in the 15 days preceding the procedure
EQ-5D (quality of life scale)	EQ-5D (quality of life scale)	at 3 months,

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Jacques Sedat, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): July 6, 2021
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 19-AOIP-04; 2020-A01447-32 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No