Main Objectives1.To identify high risk patient groups for development of knee osteoarthritis (OA) in a cohort 9-10 years after meniscus, cruciate ligament and cartilage lesions.2.To determine the use of 3T MRI state of the art imaging in detecting…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective 1)
To identify high risk patient groups for development of knee osteoarthritis
(OA) in a cohort 9-10 years after meniscus, cruciate ligament and cartilage
lesions.
•Primary parameters: Kellgren-Lawrence Grading System for radiological OA of
the knee. The Altman score for radiological OA of the knee.
Objective 2)
To determine the use of 3T MRI state of the art imaging in detecting early OA
in the knee.
•Kellgren-Lawrence Grading System for radiological OA and the Altman score for
radiological OA of the knee compared to KOSS (Knee Osteoarthritis Score System)
grading for OA in MRI.
Objective 3)
To determine if functionality of the knee is affected by arthroscopic
intervention.
•Primary parameters: Noyes and Tegner questionnaires for functionality of the
knee. KOSS (Knee Osteoarthritis Score System) grading for OA in MRI.
Objective 4)
To determine if genetic predisposition (hand OA, family history) is associated
with development of OA of the knee.
•Primary parameters: DNA tests compared to the Kellgren-Lawrence Grading System
for radiological OA and the Altman score for radiological OA of the knee
Secondary outcome
Objective 1)
To identify high risk patient groups for development of knee osteoarthritis
(OA) in a cohort 9-10 years after meniscus, cruciate ligament and cartilage
lesions.
•Secondary parameters: Knee injury and Osteoarthritis Outcome Score (KOOS),
SF-36 generic health assessment questionnaire. Biomarkers in serum and urine:
CTX-II, Glc-Gal-PYD, and PIIINP
Objective 2)
To determine the use of 3T MRI state of the art imaging in detecting early OA
in the knee.
•Secondary parameters: KOSS (Knee Osteoarthritis Score System) grading for OA
in MRI compared to the Knee injury and Osteoarthritis Outcome Score
(KOOS).Objective 3)
To determine if functionality of the knee is affected by arthroscopic
intervention.
•Secondary parameters: Physical examination of instability, range of motion,
crepitus and signs of inflammation of the knee. SF-36 generic health assessment
questionnaire
Objective 4)
To determine if genetic predisposition (hand OA, family history) is associated
with development of OA of the knee.
•Secondary parameters: DNA tests compared to questionnaires for family history,
physical examination and X-ray of the hand.
Background summary
Osteoarthritis (OA) is a serious medical condition with considerable
socio-economic impact. In the Netherlands more than ¤320 million are spent on
treatment of such conditions per annum. The knee is affected in 350.000
(general practice, RIVM) to 1.400.000 (self reported in 25+ population, Picavet
et al). Moreover, knee complaints are the third largest cause for work related
problems of the locomotor system. Large prospective studies have confirmed knee
trauma to be a significant risk factor for knee OA (Wilder 2002).
If sufficient data on patients would be available on occurrence and of
progression of OA (e.g. ligament injury, obese, family, occupation etc),
certain high-risk groups of patients could be distinguished. Not only could
these patients benefit most from preventive measurements (i.e. exercise,
chondroprotective agents, cartilage transplantation etc), but this would be
cost-effective for society as well.
Method
The proposed study is based on a 1997 collected dataset of 859 patients. The
latter study focused on the validity of MRI of the knee as a cost-effective
tool to select patients who will benefit from arthroscopic treatment. These
patients had knee complaints more than four weeks. The knee complaints were
clinically and radiologically evaluated. The average age was 31 years. Based on
standard clinical assessment, patients were divided in two groups: Patients
with high suspicion of intra-articular pathology requiring arthroscopic
treatment and patients with low or absent suspicion of intra-articular
pathology therefore not needing arthroscopic. MRI was performed by all
patients.
Study objective
Main Objectives
1.To identify high risk patient groups for development of knee osteoarthritis
(OA) in a cohort 9-10 years after meniscus, cruciate ligament and cartilage
lesions.
2.To determine the use of 3T MRI state of the art imaging in detecting early OA
in the knee.
3.To determine if functionality of the knee is affected by arthroscopic
intervention.
4.To determine if genetic predisposition (hand OA, family history) is
associated with occurrence and development of OA of the knee.
Study design
The proposed study is based on a 1997 collected dataset of 859 patients.The
original data from history taking, physical examination, plain films, MRI and
arthroscopy will be made available from the original database and incorporated
in a new database.
All 859 patients are considered eligible for this study and will be recalled
for follow-up. Patients are seen at the outpatient clinic of the department of
Orthopaedic Surgery of the LUMC. Physical examination, plain films and MRI will
be performed. Mouthswabs, blood and urine will be taken. The patients are asked
to fill in three questionnaires.
In a second and last vist to the LUMC, MRI of the knee will be performed.
Study burden and risks
Two one hour visits to the LUMC.
Maximum time to complete the questionnaires at home: one hour.
Minimal X-ray exposure.
One venapunction
dr. Jan van Breemenstraat 4
1056 AB Amsterdam
Nederland
dr. Jan van Breemenstraat 4
1056 AB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Participation in the study "MRI triage for arthroscopy" 1997.
Exclusion criteria
Pregnacy. Contraindications for MRI: pacemaker, implants etc.
Design
Recruitment
metc-ldd@lumc.nl
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 | NL13029.058.06 |