Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03746184 |
| Other study ID # |
CAGROAD_TREATright_2018 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 23, 2018 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Hvidovre University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The treatment that patients with knee OA are offered varies largely. There is a need for more
evidence-based individualized guidance to treatment choice for knee osteoarthritis. This
study will register and evaluate the course and outcome of treatment in 5,000 patients with
knee osteoarthritis. The understanding of knee OA treatment will advance in three ways:
Firstly, by describing the different treatment pathways that are currently being used for
knee OA. Secondly, by identifying wich individual factors that may impact the outcome of the
treatment course. And finally, by conducting the economic burden related to different
treatment modalities.
Description:
The problem: Knee Osteoarthritis (OA), the most common form of arthritis, is a chronic,
widespread disease with a steadily increasing prevalence that places a major economic burden
on the society. Patients with knee OA suffer from chronic knee pain and functional
disabilities. The treatment that patients with knee OA are offered varies largely, and is
often not in coherence with clinical guidelines. The guidelines recommend patient education,
exercise, and weight control as core interventions for all patients with knee OA and surgical
intervention for end-stage knee OA. However, the timing of surgery is debated, and whether
the outcome of different treatment strategies depend on individual factors such as the
patients symptoms, OA severity, or prior treatment, has not been established.
The solution: This large-scale study aims at improving the understanding of which treatment
should be offered to which patient with knee OA at which time. The study is an
interdisciplinary, collaborative effort, including orthopaedic surgeons, physiotherapists and
general practitioners from two different regions in Denmark. At least 5,000 patients with
primary referrals to orthopaedic surgeons due to knee OA, at two public hospitals, will be
recruited through a two-year inclusion period. Patients' prior treatment and symptom severity
will be registered at the first consultation with the orthopaedic surgeon using a patient
self-reported questionnaire. OA severity will be defined on plain standing knee radiographs
using a well-established classification system. The course of treatment will be registered
after 6 months and 2 years through a self-reported questionnaire with additional questions
asking whether patients can accept their current symptom state, or, if not, whether they
consider the treatment to have failed.
Societal impact and clinical implications: The understanding of knee OA treatment will
advance in three ways: Firstly, our results will improve the overview by describing the
different treatment pathways that are currently being used for knee OA. Secondly, predictors
of good and poor treatment outcomes of different treatment modalities, or combinations hereof
will be identified. And finally, the cost-effectiveness of different treatment modalities
will be evaluated. These results will be used to develop a treatment algorithm to help
patients with knee OA and clinicians to tailor the right treatment at the right time through
shared decision-making.
