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Follow-up of Osteo-articular Biomarkers After Spa Therapy in a Population With Knee Osteoarthritis and Their Correlation With the Clinical Evolution (BIOMARTHROSE)

C

Ch Mont de Marsan

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Biological: Blood collection arm

Study type

Interventional

Funder types

Other

Identifiers

NCT04308369
2019-A02801-56

Details and patient eligibility

About

Spa therapy is used in the treatment of various diseases and mainly osteoarthritis. Knee osteoarthritis is a very common rheumatic disease whose prevalence increases with longer life span and is a public health problem.

The Forestier and al. study highlighted the actual benefit and confirmed the improvement of the quality of life and pain of the knee osteoarthritis patients from 6 months of spa treatment.[1] A significant decrease of 30% in the rate of Serum Hyaluronic Acid at 6 months after the end of the spa therapy was also highlighted in the Canteloup et al study.[6] This study aims to measure different osteoarticular biomarkers (hyaluronic acid, coll2-1 and CTX1) before, at the end of the spa therapy and 6 months after the spa therapy and correlate with the clinical evaluation.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patient with knee osteoarthritis defined according to the recommendations of the American College of Rheumatology (ACR):

    • painful articulation and at least one of the following three criteria: age > 50 years and/or articular crepitation and/or morning stiffness less than 30min
    • and radiographic sign of gonarthrosis with osteophyte (on X-rays of less than 3 years).
  • Patient can come to the final visit at 6 months and living within a perimeter of 30km around Dax.

  • Patient affiliated to a social security scheme.

Exclusion criteria

  • Osteoarthritis limited to patellofemoral joint.
  • A previous spa therapy of less than 6 months.
  • Spa therapies with double indication rheumatology and phlebology.
  • Patient with osteoporosis.
  • A known hepatocellular failure or known acute or end-stage renal failure.
  • Severe depressive syndrome, psychotic syndrome, immune deficiency, cardiopathy, evolutive neoplasia or infection.
  • Infiltration and/or viscosupplementation < 6 months.
  • Change in anti-osteoarthritis treatment of less than 3 months.
  • Patient under tutorship or curatorship.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

37 participants in 1 patient group

Blood collection arm
Other group
Description:
Blood collection will be performed before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Treatment:
Biological: Blood collection arm

Trial contacts and locations

1

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Central trial contact

Anne-Hélène BOIVIN; Jérôme DIMET, PharmD

Data sourced from clinicaltrials.gov

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