The Subvastus Approach in Total Knee Arthroplasty | NCT00346788

Studies
The Subvastus Approach in Total Knee Arthroplasty

NCT00346788

Sponsor

Nova Scotia Health Authority

Status

Completed

Last Update Posted

Feb 18, 2025Actual

Enrollment

126Actual

Phase

Phase 4

Conditions

Osteoarthritis

Interventions

Surgical approach for total knee arthroplasty

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jun 29, 2006

First Submission Date that Met QC Criteria

Jun 29, 2006

First Posted Date

Jun 30, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2025

Last Update Posted Date

Feb 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MIS	Experimental	minimally invasive incision	Procedure: Surgical approach for total knee arthroplasty
Standard	Active Comparator	Standard incision length	Procedure: Surgical approach for total knee arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical approach for total knee arthroplasty	Procedure	total knee arthroplasty surgery using minimally invasive surgery or standard technique.	MIS Standard

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of hospital stay		Post Operative
Range of motion at discharge and six weeks post-operatively		Discharge and six weeks post operative

Secondary Outcomes

Measure	Description	Time Frame
Wound complications		post operative until wound healed
Post-operative narcotic use		24 months post operative
Post-operative blood loss

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ross K Leighton, MD, FRCS(C)	Capital Health, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
QEII Health Sciences Centre		Halifax	Nova Scotia	B3H 3A7	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019645	Arthroplasty, Replacement, Knee

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided