Is Meniscal Volume Critical to Post-meniscectomy Symptoms?

Completed

• Conditions: Meniscal Tear

• Registration Number: NCT04647942
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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 2.1 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.

2.2 Primary endpoints How much volume can be resected peroperatively without developing postoperative pain.

2.3 Secondary endpoints A possible correlation between the resected volume and the severity of the pain.

3. Selection and withdrawal of subjects

3.1 Inclusion criteria

* All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's.

* 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.

3.2 Exclusion criteria

* A history of a tibia plateau fracture or severe deformity of the knee

* Rupture of the ACL/PCL/collateral ligaments of the knee

* Focal cartilage defects of the knee

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-22
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-23
• Last Update Submitted: 2020-11-23
• Study First Posted: 2020-12-01
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's.
• Age between 14 and 60 years old
• Women of child bearing age can be included: the study has no effect on their methods of contraception.

Exclusion Criteria

• A history of a tibia plateau fracture or severe deformity of the knee
• Rupture of the ACL/PCL/collateral ligaments of the knee
• Focal cartilage defects of the knee

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
How much volume can be resected peroperatively without developing postoperative pain.	3 years	A possible correlation between the resected volume and the severity of the pain.

Trial Locations

Locations (1)

University Hospitals of Leuven; 🇧🇪 Leuven, Antwerp, Belgium