Is Meniscal Volume Critical to Post-meniscectomy Symptoms? | NCT04647942

Studies
Is Meniscal Volume Critical to Post-meniscectomy Symptoms?

NCT04647942

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Dec 1, 2020Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Meniscal Tear

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013Actual

Primary Completion Date

Dec 2015Actual

Completion Date

Feb 2016Actual

First Submitted Date

Dec 22, 2013

First Submission Date that Met QC Criteria

Nov 23, 2020

First Posted Date

Dec 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2020

Last Update Posted Date

Dec 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.
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.
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Label	Type	Description	Intervention Names
Meniscectomy		Patients who underwent a meniscectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johan Bellemans, MD, PhD	UZ Leuven	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Leuven		Leuven	Antwerp	3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided