NCT04647942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

December 22, 2013

Last Update Submit

November 23, 2020

Conditions

Keywords

meniscectomyvolumepain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Meniscectomy

Patients who underwent a meniscectomy

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leuven

Leuven, Antwerp, 3000, Belgium

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Johan Bellemans, MD, PhD

    UZ Leuven

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2013

First Posted

December 1, 2020

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

December 1, 2020

Record last verified: 2020-11

Locations