The Subvastus Approach in Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Surgical approach for total knee arthroplasty

• Registration Number: NCT00346788
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

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

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-06-29
• Study First Submitted QC: 2006-06-29
• Study First Posted: 2006-06-30
• Status Verified: 2008-05
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIS	Surgical approach for total knee arthroplasty	minimally invasive incision
Standard	Surgical approach for total knee arthroplasty	Standard incision length

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	Post Operative
Range of motion at discharge and six weeks post-operatively	Discharge and six weeks post operative

Secondary Outcome Measures

Name	Time	Method
Wound complications	post operative until wound healed
Post-operative narcotic use	24 months post operative
Post-operative blood loss	Post operative
The ability to straight-leg raise at two and twenty-four hours post-operatively	2 and 24 hours post operative
Knee Society Clinical Rating Scale	pre-op, 6 months, 12 months, and 24 months post operative
SF-12	pre-op, 6 months, 12 months, and 24 months post operative
WOMAC.	pre-op, 6 months, 12 months, and 24 months post operative

Trial Locations

Locations (1)

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada