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OpenTrials
Completed

NCT Number: NCT01777009

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lenox Hill Hospital

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary Total Knee Replacement Surgery

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.

Primary outcomes

  1. change in quadriceps strength

    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.

Secondary outcomes

  1. change in ability to perform straight leg raise

    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.

  2. change in Visual Analog Scale of Pain

    Time frame: preop, up to 3 days postop, 6 weeks, 3 months, and 1 year postop

    Patient reported pain using standardized VAS diagram

  3. change in Ambulation Distance

    Time frame: up to 3 days postop

  4. Length of Hospital Stay

    Time frame: expected average 2 to 3 days

  5. change in SF-36 score

    Time frame: preop, 6 weeks, 3 months, 1 year postop

  6. change in Range of knee motion

    Time frame: preop, 6 weeks, 3months, 1 year

    goniometer used to standardize measurements

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

A Randomized, Controlled, Prospective Study Evaluating the Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty.

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2013
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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