To compare the degree of osteoarthritis in the knee after 10 years, in patients with non-obstructive meniscal tear, between meniscal surgery and exercise therapy treatment.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome will be the progression of osteoarthritis scored
according to the MOAKS score. The MOAKS score is a new semi-quantitative
scoring tool to quantify OA status based on MRI images. The degree of knee
osteoarthritis is also assessed through X-ray images, using the Kellgren and
Lawrence (KL) grading scale which evaluates knee osteoarthritis at 5 different
levels, ranging from 0 (no osteoarthritis) to 4 (severe knee osteoarthritis).
Furthermore, the progression of OA is also measured using the Osteoarthritis
Research Society International (OARSI) Atlas sum score, ranging from 0 to 18
based on 6 items.
Secondary outcome
The secondary outcome measures of the study include knee function, pain, and
quality of life, assessed through digital questionnaires (Patient-Reported
Outcome Measures or PROMs). The following questionnaires will be utilized:
- KOOS (Knee injury and Osteoarthritis Outcome Score)
- EQ-5D (EuroQol-5 Dimension)
- IKDC (International Knee Documentation Committee)
- VAS Pain (Visual Analog Scale for Pain)
Background summary
Knee osteoarthritis (OA) is a condition with a significant burden on both the
patient and society. Randomized clinical trials have shown that arthroscopic
partial meniscectomy is not beneficial in terms of physical functionality
compared to exercise therapy in the first two years. There are indications that
meniscal surgery is one of the etiological factors for the accelerated
development of OA in the operated knee. However, this has not been convincingly
demonstrated in a long term RCT. We would like to further investigate the
progression of OA at a minimum of 10 years follow-up.
Study objective
To compare the degree of osteoarthritis in the knee after 10 years, in patients
with non-obstructive meniscal tear, between meniscal surgery and exercise
therapy treatment.
Study design
The research is a follow-up to the ESCAPE trial, where patients aged 45-70 with
a non-obstructive meniscus tear were randomized to undergo either surgery or
physiotherapy. In this subsequent study, the progression of osteoarthritis in
the affected knee is examined ten years after treatment. This is assessed using
MRI and X-ray images, which are compared to the baseline photos. All patients
reach the ten year point after their treatment between juli 2023 and november
2025.
Study burden and risks
The burden consists, on the one hand, of a one-time hospital visit where MRI
and X-rays will be taken (approximately 60 minutes). The latter carries a small
risk of harm due to the use of radiation, but is not considered dangerous. In
addition, the participant will complete a one-time set of questionnaires
(maximum 30 minutes). The total time that a patient is burdened during the
study is approximately 90 minutes.
Particapant benefit from the study in getting a evaluation of their current
health condition. Patients are able to see the results in their "MijnOLVG''
page.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
Patients diagnosed with a non-obstructive meniscal tear 10 years ago who
participated in the ESCAPE trial.
Exclusion criteria
Not providing informed consent or indicated not to be approached for follow-up
research.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84754.100.23 |