Is Meniscal Volume Critical to Post-meniscectomy Symptoms?

Meniscal Tear Clinical Trial

Official title:

Is Meniscal Volume Critical to Post-meniscectomy Symptoms? A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647942
• Other study ID #: V1 07112013
• Status: Completed
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: November 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniscal Tear

Locations

Country	Name	City	State
Belgium	University Hospitals of Leuven	Leuven	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	How much volume can be resected peroperatively without developing postoperative pain.	A possible correlation between the resected volume and the severity of the pain.	3 years