The Subvastus Approach in Total Knee Arthroplasty

NCT ID: NCT00346788

Last Updated: 2025-02-18

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

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is to determine if the observed benefits of minimally invasive total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be achieved with standard knee arthroplasty using the subvastus approach.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MIS

minimally invasive incision

Group Type EXPERIMENTAL

Surgical approach for total knee arthroplasty

Intervention Type PROCEDURE

total knee arthroplasty surgery using minimally invasive surgery or standard technique.

Standard

Standard incision length

Group Type ACTIVE_COMPARATOR

Surgical approach for total knee arthroplasty

Intervention Type PROCEDURE

total knee arthroplasty surgery using minimally invasive surgery or standard technique.

Interventions

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Surgical approach for total knee arthroplasty

total knee arthroplasty surgery using minimally invasive surgery or standard technique.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* You are willing to take part in the study, including signing this form after carefully reading it.
* You are available for follow-up for a minimum of 24 months (2 years).
* You have no medical conditions that prevent you from having surgery.
* This is the primary (first) knee replacement for this knee
* You are fluent in English and are able to understand your responsibilities in this study.

Exclusion Criteria

* Active, local or systemic infection
* Fibromyalgia or other chronic pain syndrome
* Inability to follow the study requirements
* Had this knee replaced before
* Had a previous surgery on this knee that would interfere with the MIS approach (examples are femoral-femoral bypass, femoral-popliteal bypass, and quadricepsplasty)
* Body Mass Index (BMI) \> 35, as you would not be eligible for the MIS approach.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ross K Leighton, MD, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Capital Health, Canada

Locations

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QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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CDHA-RL-001

Identifier Type: -

Identifier Source: org_study_id

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