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Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01132378
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : November 19, 2013
Last Update Posted : January 17, 2014
Sponsor:
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
R. David Heekin, Heekin Orthopedic Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Osteoarthritis
Intervention Procedure: Total knee arthroplasty
Enrollment 40
Recruitment Details 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 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.
Arm/Group Title Mini-midvastus Incision
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 40
Completed 40
Not Completed 0
Arm/Group Title Median Parepatellar Approach or Minimidvastus Approach
Hide Arm/Group Description Total knee arthroplasty : staged bilateral total knee arthroplasty
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
65.13  (6.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
14
  35.0%
Male
26
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Knee Society Score
Hide Description The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain
Time Frame 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medial Parapatellar Approach Mini-midvastus Approach
Hide Arm/Group Description:
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.
Total knee arthroplasty : staged bilateral total knee arthroplasty
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: score
98.70  (2.32) 99.03  (1.92)
2.Secondary Outcome
Title Quadriceps Strength
Hide Description [Not Specified]
Time Frame 2 year
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Midvastus or Medial Parapatellar Approach
Hide Arm/Group Description 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.
All-Cause Mortality
Midvastus or Medial Parapatellar Approach
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Midvastus or Medial Parapatellar Approach
Affected / at Risk (%)
Total   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Midvastus or Medial Parapatellar Approach
Affected / at Risk (%)
Total   0/40 (0.00%) 
The strength of the study is the standardized surgical protocol performed by a single surgeon and a prospectively randomized consecutive and blinded subjects
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
Responsible Party: R. David Heekin, Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier: NCT01132378     History of Changes
Other Study ID Numbers: 06-01-01
First Submitted: May 26, 2010
First Posted: May 28, 2010
Results First Submitted: March 19, 2013
Results First Posted: November 19, 2013
Last Update Posted: January 17, 2014