Lenox Hill Hospital
New York, 10021, United States
NCT Number: NCT01777009
Short and long term outcomes of total knee arthroplasty patients surgically exposed with patellar eversion are compared to those patients exposed by laterally retracting the patella. It was hypothesized that there would be no difference.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
New York, 10021, United States
Background:
Patellar mobilization during total knee arthroplasty (TKA) has been debated, with some proponents of minimally invasive TKA suggesting that laterally retracting, rather than everting the patella may be beneficial. It was our hypothesis that by using randomized, prospective, blinded study methods, there would be no significant difference in clinical outcome measures based solely on eversion of the patella during total knee arthroplasty.
Methods:
After an a priori power analysis was done, 120 primary total knee replacements indicated for degenerative joint disease were included in the study and randomized to one of two patella exposure techniques: lateral retraction or eversion. Collaborating investigators and patients were blinded to randomization.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients randomized to the eversion group had patellas everted during the flexion portions of the surgery. Patients randomized to the retraction group had patellas everted only for the patellar resurfacing portions of the surgery. Both groups were mobilized with anterior tibial translation. All other aspects of surgery including postoperative care, anticoagulation, pain control, and physical therapy were done as per standard arthroplasty protocols at our institution.
Time frame: preop, 6 weeks, 3 months, 1 year postop
Quadriceps strength was measured isometrically using a Biodex dynamometer with the patient's knee in 60 degrees of flexion.
Time frame: up to three days postop
For the purposes of this study, we defined the ability to straight leg raise as a patient independently raising their heel 6 inches off of the bed with foot dorsiflexed and knee fully extended without extension lag.
Time frame: preop, up to 3 days postop, 6 weeks, 3 months, and 1 year postop
Patient reported pain using standardized VAS diagram
Time frame: up to 3 days postop
Time frame: expected average 2 to 3 days
Time frame: preop, 6 weeks, 3 months, 1 year postop
Time frame: preop, 6 weeks, 3months, 1 year
goniometer used to standardize measurements
Northwell Health
Other
A Randomized, Controlled, Prospective Study Evaluating the Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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