Trial Outcomes & Findings for Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty (NCT NCT01132378)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

2 year

Results posted on

2014-01-17

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Median Parepatellar Approach or Minimidvastus Approach n=40 Participants Total knee arthroplasty : staged bilateral total knee arthroplasty
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	65.13 years STANDARD_DEVIATION 6.49 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 year

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

Outcome measures

Outcome measures
Measure	Medial Parapatellar Approach n=40 Participants 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.	Mini-midvastus Approach n=40 Participants Total knee arthroplasty : staged bilateral total knee arthroplasty
Knee Society Score	98.70 score Standard Deviation 2.32	99.03 score Standard Deviation 1.92

SECONDARY outcome

Timeframe: 2 year

Outcome measures

Outcome data not reported

Adverse Events

Midvastus or Medial Parapatellar Approach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

R. David Heekin MD, FACS

Heekin Institute for Orthopaedic Research

Phone: 904-634-0640

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place