Clinical trial NCT04158557: Strategies for Management of Knee Osteoarthritis : Innovation and Medico-economic Study
Official title: Strategies for Management of Knee Osteoarthritis : Innovation and Medico-economic Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male of female aged from 18 to 85 years with moderate to severe knee osteoarthritis

Brief summary: Osteoarthritis is an evolving joint disease caused by degeneration of bones and cartilage, with significant personal and social impact. Osteoarthritis of the knee is the most common type of osteoarthritis, affecting up to 19% of adults (aged 45 and over) according to recent studies.

The costs associated with the management of osteoarthritis involve not only direct treatment strategies (clinical evaluations, drugs, prostheses, surgery), but also significant indirect costs (loss of productivity) The severity of knee osteoarthriris symptoms and the types of interventions are highly variable. There are surgical and nonsurgical treatment strategies. The replacement of the knee joint by a total prosthesis is a surgical choice for severe knee osteoarthritis which currently represents the basic treatment. However, a large proportion of patients with knee osteoarthritis can not or do not wish to have surgery, either because of the unavailability of the choice of surgery, or the disability and post-operative pain that can be caused by surgery.

Since surgery is not always the preferred or available treatment for people with knee osteoarthritis, it has been shown that acting on modifiable risk factors (severe obesity) can significantly reduce the pain and disability but it is not always sufficient.

Other effective therapeutic osteoarthritis strategies include biomechanical interventions, intra-articular injections like corticosteroids ; anti-inflammatory and analgesic drugs, exercise, patient education and bodybuilding. There is also an innovative strategy that is under development and consists of the use of nanostructured and functionalized implants for bone and cartilage regeneration.

The objective of this study is to carry out a medico-economic study centered on knee osteoarthritis management strategies. At a time when the decisions of management of pathologies must be based on the efficiency of the possible therapies, and given the high prevalence of knee osteoarthritis, it appears crucial to carry out this type of study in order to 'bring elements to public health decision makers. In addition, there is a demand for medico-economic assessment of osteoarthritis management strategies emerging in the literature. To carry out this study, we plan to carry out an extensive review of the literature on relevant non-surgical strategies for patients with moderate and severe knee osteoarthritis and for whom total knee replacement was feasible. This will aim to extract data to develop a modeling (Markov models) of knee osteoarthritis management by different therapeutic strategies. At this stage, the cost and quality of life data for the models will be searched in order to be linked to the strategy cost within a medico-economic evaluation.

If the literature proves to be insufficient, the use of the data of the University Hospitals of Strasbourg (retrospective study), the realization of an epidemiological study (prospective study) will be a possible in order to make the model.


Eligibility criteria: Inclusion Criteria:

* moderate or severe knee osteoarthritis

Exclusion Criteria:

* another disease than knee osteoarthritis

Primary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: baseline and 12 months
measure: The Short Form (36) Health Survey (SF-36)
timeFrame: baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Inserm-Unistra, Umr 1260
state: Alsace
Study officials:
References: