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Minimally Invasive Surgical Approaches In Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01461356
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : October 28, 2011
Sponsor:
Information provided by (Responsible Party):
Mark Pagnano, Mayo Clinic

Brief Summary:

The hypothesis of the proposed study is that performing total knee arthroplasty through a mini subvastus approach results in statistically significant differences in one or more of the above functional outcome measures, when compared in a blinded, prospective, controlled, randomized manner to mini-medial arthrotomy approach.

  1. Analyses of lower extremity functional activities (gait and stairs)
  2. Strength of thigh musculature
  3. Self-assessment of the functional outcomes
  4. Return to the activities of daily living and sports activities

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Minimally invasive total knee replacement Procedure: Standard approach total knee replacement Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Controlled, Blinded Functional Outcomes Of Two Contemporary Surgical Approaches In Total Knee Arthroplasty
Study Start Date : March 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Minimally Invasive Surgical approach
Minimally invasive surgical approach for total knee replacement.
Procedure: Minimally invasive total knee replacement
A cemented tricompartmental total knee replacement will be performed using a minimally invasive surgical approach.
Other Names:
  • Posterior stabilzed total knee replacement.
  • Minimally invasive total knee replacement.
Active Comparator: Medial Parapatellar surgical approach
Standard medial parapateller surgical approach for total knee replacement.
Procedure: Standard approach total knee replacement
A cemented tricompartmental total knee replacement will be performed using a traditional medial parapatellar surgical approach.
Other Names:
  • Posterior stabilized total knee replacement.
  • Minimally invasive total knee replacment.



Primary Outcome Measures :
  1. Knee Society Clinical Rating Score [ Time Frame: 2 months ]
    The two patient cohorts, minimally invasive surgical approach and standard medial parapatellar approach, will be followed prospectively and evaluated with the Knee Society Clinical Rating Score.


Secondary Outcome Measures :
  1. Comprehensive gait analysis [ Time Frame: 2 months ]
    Spatiotemporal gait parameters will be measured in the gait analysis lab and compared between the two groups to determine if a functional difference is detectable between the two different surgical approaches.



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary arthroplasty
  • Age between 45 and 75 years old
  • Single condylar implant design

Exclusion Criteria:

  • Revision arthroplasty
  • Age less than 45 and greater than 75 years old
  • Pre-operative flexion lower than 90 degrees
  • Valgus or varus knee deformity greater than 15 degrees.
  • The presence of infections, highly communicable diseases (AIDS, active tuberculosis, venereal disease, hepatitis) or metastasis disease.
  • Significant neurological or musculoskeletal disorders or disease that may interfere with normal gait or weight bearing.
  • Any congenital, developmental, or other bone disease or previous hip surgery that may, in the surgeon's judgment, interfere with TK prosthesis survival or success.
  • Presence of previous prosthetic knee or hip replacement device.
  • BMI > 30.
  • Pregnant women.

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): NCT01461356


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark W Pagnano, MD Mayo Clinic

Responsible Party: Mark Pagnano, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01461356     History of Changes
Other Study ID Numbers: 07-001613
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: October 2011

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