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The Subvastus Approach in Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00346788
First received: June 29, 2006
Last updated: June 27, 2011
Last verified: May 2008
History of Changes
  Purpose

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 Intervention Phase
Osteoarthritis
 Procedure: Surgical approach for total knee arthroplasty
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Subvastus Approach in Total Knee Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: Post Operative ] [ Designated as safety issue: No ]
  • Range of motion at discharge and six weeks post-operatively [ Time Frame: Discharge and six weeks post operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wound complications [ Time Frame: post operative until wound healed ] [ Designated as safety issue: Yes ]
  • Post-operative narcotic use [ Time Frame: 24 months post operative ] [ Designated as safety issue: Yes ]
  • Post-operative blood loss [ Time Frame: Post operative ] [ Designated as safety issue: Yes ]
  • The ability to straight-leg raise at two and twenty-four hours post-operatively [ Time Frame: 2 and 24 hours post operative ] [ Designated as safety issue: No ]
  • Knee Society Clinical Rating Scale [ Time Frame: pre-op, 6 months, 12 months, and 24 months post operative ] [ Designated as safety issue: No ]
  • SF-12 [ Time Frame: pre-op, 6 months, 12 months, and 24 months post operative ] [ Designated as safety issue: No ]
  • WOMAC. [ Time Frame: pre-op, 6 months, 12 months, and 24 months post operative ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: January 2005
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346788

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

No publications provided

Responsible Party: Ross K. Leighton, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00346788     History of Changes
Other Study ID Numbers: CDHA-RL-001
Study First Received: June 29, 2006
Last Updated: June 27, 2011
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 19, 2013