Prognostic factors for cartilage degeneration in the knee after meniscectomy and cruciate ligament injuries. A prospective observational magnetic resonance imaging cohort study.
| ISRCTN | ISRCTN44431821 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44431821 |
| Secondary identifying numbers | NL708, NTR718 |
- Submission date
- 21/07/2006
- Registration date
- 21/07/2006
- Last edited
- 08/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr K. Huétink
Scientific
Scientific
Leiden University Medical Center (LUMC)
P.O. Box 9600
Leiden
2333 ZA
Netherlands
| Phone | +31 (0)71 5262052 |
|---|---|
| k.huetink@lumc.nl |
Study information
| Study design | A prospective, observational, cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Not specified |
| Study type | Screening |
| Scientific title | Prognostic factors for cartilage degeneration in the knee after meniscectomy and cruciate ligament injuries. A prospective observational magnetic resonance imaging cohort study. |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | 1. X-ray 2. MRI 3. Venapunction |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | To determine the use of 3T (for tesla) MRI state of the art imaging in detecting early OA in the knee |
| Overall study start date | 01/08/2006 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 700 |
| Total final enrolment | 326 |
| Key inclusion criteria | Patients who participated in the 1997 study "MRI triage for arthroscopy" |
| Key exclusion criteria | 1. Pregnancy 2. Contraindications for magnetic resonance imaging (MRI) e.g. pacemaker, metal implants, intrauterine device (IUD) etc |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center (LUMC)
Leiden
2333 ZA
Netherlands
2333 ZA
Netherlands
Sponsor information
Dutch Arthritis Association (The Netherlands)
Charity
Charity
Dr. Jan van Breemenstraat 4
P.O. Box 59091
Amsterdam
1040 KB
Netherlands
| Phone | +31 (0)20 5896464 |
|---|---|
| research@reumafonds.nl | |
"ROR" |
https://ror.org/05dr3r825 |
Funders
Funder type
Charity
Dutch Arthritis Association (rheumatism fund)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2010 | 08/01/2021 | Yes | No |
Editorial Notes
08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
