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Is Meniscal Volume Critical to Post-meniscectomy Symptoms?

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT04647942
Collaborator
(none)
90
Enrollment
1
Location
26
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    1. 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 Design

    Study Type:
    Observational
    Actual Enrollment :
    90 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Is Meniscal Volume Critical to Post-meniscectomy Symptoms? A Retrospective Study
    Actual Study Start Date :
    Dec 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Feb 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Meniscectomy

    Patients who underwent a meniscectomy

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals of Leuven Leuven Antwerp Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    • Study Director: Johan Bellemans, MD, PhD, UZ Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT04647942
    Other Study ID Numbers:
    • V1 07112013
    First Posted:
    Dec 1, 2020
    Last Update Posted:
    Dec 1, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by Universitaire Ziekenhuizen Leuven
    meniscectomy
    volume
    pain

    Study Results

    No Results Posted as of Dec 1, 2020