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The Subvastus Approach in Total Knee Arthroplasty

The Subvastus Approach in Total Knee Arthroplasty

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00346788
Enrollment
126
Registered
2006-06-30
Start date
2005-01-31
Completion date
2011-03-31
Last updated
2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

PROCEDURESurgical approach for total knee arthroplasty

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

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Length of hospital stayPost Operative
Range of motion at discharge and six weeks post-operativelyDischarge and six weeks post operative

Secondary

MeasureTime frame
Post-operative blood lossPost operative
The ability to straight-leg raise at two and twenty-four hours post-operatively2 and 24 hours post operative
Wound complicationspost operative until wound healed
SF-12pre-op, 6 months, 12 months, and 24 months post operative
WOMAC.pre-op, 6 months, 12 months, and 24 months post operative
Knee Society Clinical Rating Scalepre-op, 6 months, 12 months, and 24 months post operative
Post-operative narcotic use24 months post operative

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026