Minimally Invasive Surgical Approaches In Total Knee Arthroplasty
|ClinicalTrials.gov Identifier: NCT01461356|
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : October 28, 2011
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.
- Analyses of lower extremity functional activities (gait and stairs)
- Strength of thigh musculature
- Self-assessment of the functional outcomes
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461356
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Mark W Pagnano, MD||Mayo Clinic|