Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Minimally Invasive Surgical Approaches In Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Pagnano, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01461356
First received: October 20, 2011
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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 Intervention
Knee Osteoarthritis
Procedure: Minimally invasive total knee replacement
Procedure: Standard approach total knee replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Controlled, Blinded Functional Outcomes Of Two Contemporary Surgical Approaches In Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Knee Society Clinical Rating Score [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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:
  • Comprehensive gait analysis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: March 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mark Pagnano, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01461356     History of Changes
Other Study ID Numbers: 07-001613
Study First Received: October 20, 2011
Last Updated: October 27, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 24, 2014