The Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty
- Conditions
- Total Knee ReplacementArthroplastyPatella
- Interventions
- Procedure: Primary Total Knee Replacement Surgery
- Registration Number
- NCT01777009
- Lead Sponsor
- Northwell Health
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Patients eligible for study participation included all comers for primary total knee arthroplasty indicated for degenerative joint disease. All operations were performed by three well-established arthroplasty-fellowship-trained orthopaedic surgeons using surgical techniques based on that of a senior surgeon. All implanted devices were cruciate-substituting tricompartmental total knee replacements placed through a medial parapatellar approach. All patients were anaesthetized with spinal anesthesia, received a peri-operative cocktail injection, and had tourniquet times between 0 and 120 minutes. Multi-modal post-operative pain management and accelerated physical therapy were performed as previously described.
- Patients were excluded from the study if on the operative side they had undergone prior total knee replacement, prior knee arthrotomy, prior osteotomy at or about the knee, or had preoperative angular deformity greater than 20 degrees.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patellar Eversion Primary Total Knee Replacement Surgery Patients randomized to the Patellar Eversion arm of the study were surgically exposed by everting the patella during their Primary Total Knee Replacement Surgery. Patellar Lateral Retraction Primary Total Knee Replacement Surgery Patients randomized to the Patellar Lateral Retraction arm of the study were surgically exposed by laterally retracting the patella during their Primary Total Knee Replacement Surgery.
- Primary Outcome Measures
Name Time Method change in quadriceps strength 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.
- Secondary Outcome Measures
Name Time Method change in ability to perform straight leg raise 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.
change in Visual Analog Scale of Pain preop, up to 3 days postop, 6 weeks, 3 months, and 1 year postop Patient reported pain using standardized VAS diagram
change in Ambulation Distance up to 3 days postop Length of Hospital Stay expected average 2 to 3 days change in SF-36 score preop, 6 weeks, 3 months, 1 year postop change in Range of knee motion preop, 6 weeks, 3months, 1 year goniometer used to standardize measurements
Trial Locations
- Locations (1)
Lenox Hill Hospital
🇺🇸New York, New York, United States