Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647942
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2013-12-22
Brief Title:
Is Meniscal Volume Critical to Post-meniscectomy Symptoms
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Is Meniscal Volume Critical to Post-meniscectomy Symptoms A Retrospective Study
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With this study we would like to investigate whether a certain critical loss of meniscal volume is critical to the development of pain
Detailed Description:
1 Background and rationale It is known that a partial meniscectomy of the knee is a risk factor to the development of early osteoarthritis with complaints of pain
2 Trial objectives and Design 21 Trial objectives With this study we would like to investigate whether a certain critical loss of meniscal volume is critical to the development of pain
22 Primary endpoints How much volume can be resected peroperatively without developing postoperative pain
23 Secondary endpoints A possible correlation between the resected volume and the severity of the pain
3 Selection and withdrawal of subjects
31 Inclusion criteria
All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRIs
Age between 14 and 50 years old
Women of child bearing age can be included the study has no effect on their methods of contraception
32 Exclusion criteria
A history of a tibia plateau fracture or severe deformity of the knee
Rupture of the ACLPCLcollateral ligaments of the knee
Focal cartilage defects of the knee
2 Trial objectives and Design 21 Trial objectives With this study we would like to investigate whether a certain critical loss of meniscal volume is critical to the development of pain
22 Primary endpoints How much volume can be resected peroperatively without developing postoperative pain
23 Secondary endpoints A possible correlation between the resected volume and the severity of the pain
3 Selection and withdrawal of subjects
31 Inclusion criteria
All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRIs
Age between 14 and 50 years old
Women of child bearing age can be included the study has no effect on their methods of contraception
32 Exclusion criteria
A history of a tibia plateau fracture or severe deformity of the knee
Rupture of the ACLPCLcollateral ligaments of the knee
Focal cartilage defects of the knee
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None