Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial

NCT ID: NCT00925626

Last Updated: 2021-07-07

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

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2015-08-31

Brief Summary

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Randomized, single-blind trial in which one group of patients will be operated with a "Mid-Vastus approach" of the knee joint and the other group will undergo knee surgery with a "Sub-Vastus approach".

Detailed Description

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Conditions

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Tricompartmental Gonarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sub - Vastus arthrotomy

Sub-vastus arthrotomy

Group Type EXPERIMENTAL

Sub-Vastus arthrotomy

Intervention Type PROCEDURE

Sub-vastus arthrotomy

Mid-Vastus arthrotomy

Mid-vastus arthrotomy

Group Type ACTIVE_COMPARATOR

Mid - Vastus arthrotomy

Intervention Type PROCEDURE

Mid-vastus arthrotomy

Interventions

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Sub-Vastus arthrotomy

Sub-vastus arthrotomy

Intervention Type PROCEDURE

Mid - Vastus arthrotomy

Mid-vastus arthrotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients diagnosed with osteoarthrosis of the knee
* patients must be in good general health condition

Exclusion Criteria

* patients with morbid obesity (BMI \>45)
* patients with history of knee surgery, infection or inflammatory disease of the knee joint or large cartilage lesion
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Verdonk, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

website of the University Hospital Ghent

Other Identifiers

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2009/256

Identifier Type: -

Identifier Source: org_study_id

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