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

NCT01777009 | Completed DMC

• 1 other identifier: Patellar Mobilization
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Replacement; Arthroplasty; Patella

Keywords

Total Knee Replacement; Patellar Eversion; Surgical Exposure; Outcomes; Quadriceps Strength; Straight Leg Raise; SF-36

Outcome Measures

Primary Outcomes (1)

• change in quadriceps strength

  Quadriceps strength was measured isometrically using a Biodex dynamometer with the patient's knee in 60 degrees of flexion.

  preop, 6 weeks, 3 months, 1 year postop

Secondary Outcomes (6)

• change in ability to perform straight leg raise

  up to three days postop

• change in Visual Analog Scale of Pain

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

• 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

Study Arms (2)

Patellar Eversion

EXPERIMENTAL

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

Patellar Lateral Retraction

ACTIVE COMPARATOR

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

Interventions

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.

Patellar Eversion; Patellar Lateral Retraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Patella Fracture

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Jose A Rodriguez, MD

  Lenox Hill Hospital

  PRINCIPAL INVESTIGATOR

• Derek R Jenkins, MD

  Mayo Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 28, 2013
• Study Start: March 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

US (1)