The Subvastus Approach in Total Knee Arthroplasty

Nova Scotia Health Authority126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Osteoarthritis

Interventions

Surgical approach for total knee arthroplastyPROCEDURE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Outcomes

Primary Outcomes

Length of hospital stay

Time frame: Post Operative

Range of motion at discharge and six weeks post-operatively

Time frame: Discharge and six weeks post operative

Secondary Outcomes

Wound complications

Time frame: post operative until wound healed

Post-operative narcotic use

Time frame: 24 months post operative

Post-operative blood loss

Time frame: Post operative

The ability to straight-leg raise at two and twenty-four hours post-operatively

Time frame: 2 and 24 hours post operative

Knee Society Clinical Rating Scale

Time frame: pre-op, 6 months, 12 months, and 24 months post operative

SF-12

Time frame: pre-op, 6 months, 12 months, and 24 months post operative

WOMAC.

Time frame: pre-op, 6 months, 12 months, and 24 months post operative

Data from ClinicalTrials.gov

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