Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527235
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Ultrasound-monitored Meniscal Wall Betamethasone Infiltration on Pain in Relation to Degenerative Meniscal Injury a Randomized Double-blind Placebo-controlled Multicenter Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINUS
Brief Summary:
The value of corticosteroid infiltration of the meniscus wall in the therapeutic strategy is not clearly defined the data in the literature on the effectiveness of corticosteroid infiltration are heterogeneous and of low level of proof We hypothesize that corticosteroid infiltration of the meniscal wall under ultrasound control would be effective for rapid relief of degenerative meniscal pain
The main objective is to evaluate the efficacy of ultrasound-guided meniscal wall infiltration of betamethasone versus ultrasound-guided meniscal wall infiltration of placebo at 1 month on meniscal pain in the treatment of meniscal pain of degenerative origin in adult
The main objective is to evaluate the efficacy of ultrasound-guided meniscal wall infiltration of betamethasone versus ultrasound-guided meniscal wall infiltration of placebo at 1 month on meniscal pain in the treatment of meniscal pain of degenerative origin in adult
Detailed Description:
Meniscal pain is a very frequent cause of consultation in orthopedics rheumatology or sports medicine The management of degenerative meniscal lesions has been the subject of a consensus conference by the French Authority 2008 and a recommendation by the European Society of Sports Traumatology Knee Surgery and Arthroscopy ESSKA 2017 which propose symptomatic medical treatment before any surgical management Conservative medical treatment is the first-line treatment for most patients with symptomatic meniscal injuries with a wide range of therapies including rehabilitation oral nonsteroidal anti-inflammatory drugs joint injections of corticosteroid hyaluronic acid or platelet concentrates as well as injection of corticosteroids into the posterior meniscal wall In the therapeutic arsenal corticosteroid infiltrations of the posterior meniscus wall are those that have been the subject of the most clinical studies yet the data in the literature on the efficacy of these corticosteroid infiltrations are of low level of evidence This is why the European Society of Musculoskeletal Radiologys Delphi-based consensus group on musculoskeletal imaging ESSR is encouraging the development of clinical research in this field with a placebo control group in order to allow an objective validation of perimeniscal corticosteroid injection procedures in the treatment of meniscal pain of degenerative origin
The present study is a multicenter randomized controlled trial in double blind patient and evaluator versus placebo Only the physician performing the infiltration will know the status of the group assigned to the patient experimental or placebo
Enrollment will be prospective from the active line of patients followed in the investigating centers A telephone pre-inclusion visit will be done at least 7 days before the inclusion visit The inclusion visit randomization stratified on the centre and infiltration will be performed on the same day The follow-up will include a consultation at 1 month and two phone call at 7 days and 3 months
The present study is a multicenter randomized controlled trial in double blind patient and evaluator versus placebo Only the physician performing the infiltration will know the status of the group assigned to the patient experimental or placebo
Enrollment will be prospective from the active line of patients followed in the investigating centers A telephone pre-inclusion visit will be done at least 7 days before the inclusion visit The inclusion visit randomization stratified on the centre and infiltration will be performed on the same day The follow-up will include a consultation at 1 month and two phone call at 7 days and 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None