The Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty

NCT ID: NCT01777009

Last Updated: 2013-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-04-30

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.

Conditions

Total Knee Replacement; Arthroplasty; Patella

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Patellar Eversion

Patients randomized to the Patellar Eversion arm of the study were surgically exposed by everting the patella during their Primary Total Knee Replacement Surgery.

Group Type: EXPERIMENTAL

Primary Total Knee Replacement Surgery

Intervention Type: PROCEDURE

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.

Patellar Lateral Retraction

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.

Group Type: ACTIVE_COMPARATOR

Primary Total Knee Replacement Surgery

Intervention Type: PROCEDURE

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.

Interventions

Primary Total Knee Replacement Surgery

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose A Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Lenox Hill Hospital

Derek R Jenkins, MD

Role: STUDY_DIRECTOR

Mayo Clinic

Locations

Lenox Hill Hospital

New York, New York, United States

Countries

United States

Other Identifiers

Patellar Mobilization

Identifier Type: -

Identifier Source: org_study_id