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The Subvastus Approach in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00346788
Recruitment Status : Completed
First Posted : June 30, 2006
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Surgical approach for total knee arthroplasty Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Subvastus Approach in Total Knee Arthroplasty
Study Start Date : January 2005
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MIS
minimally invasive incision
Procedure: Surgical approach for total knee arthroplasty
total knee arthroplasty surgery using minimally invasive surgery or standard technique.
Active Comparator: Standard
Standard incision length
Procedure: Surgical approach for total knee arthroplasty
total knee arthroplasty surgery using minimally invasive surgery or standard technique.


Outcome Measures

Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Post Operative ]
  2. Range of motion at discharge and six weeks post-operatively [ Time Frame: Discharge and six weeks post operative ]

Secondary Outcome Measures :
  1. Wound complications [ Time Frame: post operative until wound healed ]
  2. Post-operative narcotic use [ Time Frame: 24 months post operative ]
  3. Post-operative blood loss [ Time Frame: Post operative ]
  4. The ability to straight-leg raise at two and twenty-four hours post-operatively [ Time Frame: 2 and 24 hours post operative ]
  5. Knee Society Clinical Rating Scale [ Time Frame: pre-op, 6 months, 12 months, and 24 months post operative ]
  6. SF-12 [ Time Frame: pre-op, 6 months, 12 months, and 24 months post operative ]
  7. WOMAC. [ Time Frame: pre-op, 6 months, 12 months, and 24 months post operative ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346788


Locations
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Principal Investigator: Ross K Leighton, MD, FRCS(C) Capital Health, Canada
More Information

Responsible Party: Ross K. Leighton, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00346788     History of Changes
Other Study ID Numbers: CDHA-RL-001
First Posted: June 30, 2006    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: May 2008

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases