Is Meniscal Volume Critical to Post-meniscectomy Symptoms?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-02-29

Brief Summary

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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

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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

Conditions

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Meniscal Tear

Keywords

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meniscectomy volume pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Meniscectomy

Patients who underwent a meniscectomy

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johan Bellemans, MD, PhD

Role: STUDY_DIRECTOR

UZ Leuven

Locations

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University Hospitals of Leuven

Leuven, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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V1 07112013

Identifier Type: -

Identifier Source: org_study_id