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

January 22, 2013
January 25, 2013
March 2009
April 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01777009 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
The Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty
A Randomized, Controlled, Prospective Study Evaluating the Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Total Knee Replacement
  • Arthroplasty
  • Patella
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.
  • 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.
    Intervention: Procedure: Primary Total Knee Replacement Surgery
  • 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.
    Intervention: Procedure: Primary Total Knee Replacement Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01777009
Patellar Mobilization
Yes
North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
Not Provided
Principal Investigator: Jose A Rodriguez, MD Lenox Hill Hospital
Study Director: Derek R Jenkins, MD Mayo Clinic
North Shore Long Island Jewish Health System
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP