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Completed

NCT Number: NCT04647942

Is Meniscal Volume Critical to Post-meniscectomy Symptoms?

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

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Key information

Age range

14 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Leuven

Leuven, Antwerp, 3000, Belgium

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. How much volume can be resected peroperatively without developing postoperative pain.

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 1, 2020
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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