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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01777009
First received: January 22, 2013
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Total Knee Replacement
Arthroplasty
Patella
Procedure: Primary Total Knee Replacement Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Prospective Study Evaluating the Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty.

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • change in quadriceps strength [ Time Frame: preop, 6 weeks, 3 months, 1 year postop ] [ Designated as safety issue: No ]
    Quadriceps strength was measured isometrically using a Biodex dynamometer with the patient's knee in 60 degrees of flexion.


Secondary Outcome Measures:
  • change in ability to perform straight leg raise [ Time Frame: up to three days postop ] [ Designated as safety issue: No ]
    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 [ Time Frame: preop, up to 3 days postop, 6 weeks, 3 months, and 1 year postop ] [ Designated as safety issue: No ]
    Patient reported pain using standardized VAS diagram

  • change in Ambulation Distance [ Time Frame: up to 3 days postop ] [ Designated as safety issue: No ]
  • Length of Hospital Stay [ Time Frame: expected average 2 to 3 days ] [ Designated as safety issue: No ]
  • change in SF-36 score [ Time Frame: preop, 6 weeks, 3 months, 1 year postop ] [ Designated as safety issue: No ]
  • change in Range of knee motion [ Time Frame: preop, 6 weeks, 3months, 1 year ] [ Designated as safety issue: No ]
    goniometer used to standardize measurements


Enrollment: 120
Study Start Date: March 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: 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.
Active Comparator: 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.
Procedure: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777009

Locations
United States, New York
Lenox Hill Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Jose A Rodriguez, MD Lenox Hill Hospital
Study Director: Derek R Jenkins, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01777009     History of Changes
Other Study ID Numbers: Patellar Mobilization
Study First Received: January 22, 2013
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Total Knee Replacement
Patellar Eversion
Surgical Exposure
Outcomes
Quadriceps Strength
Straight Leg Raise
SF-36

ClinicalTrials.gov processed this record on November 25, 2014