The primary objective of this study is to determine the long-term clinical course in patients who consulted their general practitioner 6 years ago with a new episode of knee complaints. The secondary objectives of this study are to determine…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the long-term clinical course in patients who
consulted their general practitioner 6 years ago with a new episode of knee
complaints. The main endpoint is the amount of patients with persisting or
recurrent knee complaints after 6 years of follow-up.
Secondary outcome
Secondary parameters are possible prognostic factors for persisting or
recurrent knee complaints after 6 years of follow-up. A secondary endpoint of
this study is the amount of patients with osteoarthritis (or degenerative
symptoms) of the knee, in patients who had visited the general practitioner 6
years ago with traumatic or non-traumatic (36 year and older at baseline) knee
complaints.
Background summary
A prospective, observational cohort study has started in 2002 on the department
of general practice of the Erasmus MC. Participating patients (n=1068) visited
their general practitioner (within the academic HONEUR research network) with a
new episode of knee complaints and were followed for a period of one year.
After one year of follow-up, 50% of the patients with non-traumatic knee
complaints and 25% of the patients with traumatic knee complaints had
persistent complaints. Because of the high percentages persistent knee
complaints after one year of follow-up, the possibility of recurrent knee
complaints and to know the long-term outcome of knee complaints, it is
important to perform a long-term follow-up (6 years) of the HONEUR knee cohort.
Nowadays a long-term follow-up of patients with knee complaints is lacking
entirely.
Study objective
The primary objective of this study is to determine the long-term clinical
course in patients who consulted their general practitioner 6 years ago with a
new episode of knee complaints. The secondary objectives of this study are to
determine prognostic factors for persisting or recurrent knee complaints, the
role of the general practitioner in patients with long-term knee complaints,
the predictive value of an MRI in patients with traumatic knee complaints and
the predictive value for developing degenerative symptoms of the knee.
Study design
The study concerns a long-term follow-up (6 years) of patients within the
HONEUR prospective observational cohort study. Data will be collected with a
questionnaire, physical examination, X-ray and/or MRI of the knee.
Study burden and risks
The risk to the subject will be minimal, because the research will exist of the
usual care, except filling out an questionnaire. Burden for the subject will
also be minimal, except X-ray radiation, and will be mainly exist of time for
filling out a questionnaire, under wending a physical examination, an X-ray and
an MRI (last three only in subgroups). The X-ray radiation will be minimized
through taking the X-ray onetime and using the results of an X-ray made in the
last year. There will be no direct benefits for the patients in this study.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
At baseline, patients aged 12 years or above, consulting their general practitioner for a new episode of knee complaints, were invited to participate in the HONEUR study. All patients who had participated at baseline will be included in this 6 year follow-up study. These patients will be 18 years and older at the 6 year follow-up study.
Exclusion criteria
At baseline, patients with knee complaints that required urgent medical attention, patients with malignancies, neurological disorders or systemic musculoskeletal diseases, as well as patients that were incapable of understanding the ramifications of participation, were excluded from participation. Patients who have indicated in the past that they wish not longer to participate in the study will be excluded in this 6 year follow-up study.
Design
Recruitment
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 | NL25024.078.08 |