Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
R. David Heekin, Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier:
NCT01132378
First received: May 26, 2010
Last updated: December 16, 2013
Last verified: February 2012
Results First Received: March 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Osteoarthritis
Intervention: Procedure: Total knee arthroplasty

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Forty consecutive patients who underwent staged bilateral TKA (within no more than 7 days)were assessed at 2,6, 12 weeks and 6,12, and24 months postoperatively

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.

Reporting Groups
  Description
Mini-midvastus Incision

Total knee arthroplasty : staged bilateral total knee arthroplasty

Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini-midvastus approach in one knee and mini-Medial Parapatellar Approachthe in another knee (left or right)within no more than 7 days.


Participant Flow:   Overall Study
    Mini-midvastus Incision  
STARTED     40  
COMPLETED     40  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.

Reporting Groups
  Description
Median Parepatellar Approach or Minimidvastus Approach Total knee arthroplasty : staged bilateral total knee arthroplasty

Baseline Measures
    Median Parepatellar Approach or Minimidvastus Approach  
Number of Participants  
[units: participants]
  40  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     40  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  65.13  ± 6.49  
Gender  
[units: participants]
 
Female     14  
Male     26  
Region of Enrollment  
[units: participants]
 
United States     40  



  Outcome Measures

1.  Primary:   Knee Society Score   [ Time Frame: 2 year ]

2.  Secondary:   Quadriceps Strength   [ Time Frame: 2 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The strength of the study is the standardized surgical protocol performed by a single surgeon and a prospectively randomized consecutive and blinded subjects


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: R. David Heekin MD, FACS
Organization: Heekin Institute for Orthopaedic Research
phone: 904-634-0640
e-mail: drheekin@heekinortho.com


No publications provided


Responsible Party: R. David Heekin, Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier: NCT01132378     History of Changes
Other Study ID Numbers: 06-01-01
Study First Received: May 26, 2010
Results First Received: March 19, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board