The Subvastus Approach in Total Knee Arthroplasty
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 29, 2006
CompletedFirst Posted
Study publicly available on registry
June 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFebruary 18, 2025
May 1, 2008
6.2 years
June 29, 2006
February 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Length of hospital stay
Post Operative
Range of motion at discharge and six weeks post-operatively
Discharge and six weeks post operative
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
MIS
EXPERIMENTALminimally invasive incision
Standard
ACTIVE COMPARATORStandard incision length
Interventions
total knee arthroplasty surgery using minimally invasive surgery or standard technique.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ross K Leighton, MD, FRCS(C)
Capital Health, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2006
First Posted
June 30, 2006
Study Start
January 1, 2005
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
February 18, 2025
Record last verified: 2008-05