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
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.
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
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Mark W Pagnano, MD||Mayo Clinic|