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Clinical Trials/NCT02268097
NCT02268097
Unknown
Not Applicable

Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty.A Prospective, Randomized, Double-blind Study

Peking University Third Hospital1 site in 1 country101 target enrollmentOctober 29, 2014
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Peking University Third Hospital
Enrollment
101
Locations
1
Primary Endpoint
Patellar tilt (PT)
Last Updated
8 years ago

Overview

Brief Summary

The aim of this prospective, randomized study was to compare the clinical and radiological results of "free-hand" technique and "resection guide" technique for preparing patella during total knee arthroplasty.

Detailed Description

With improved surgical techniques and implant designs, patella resurfacing has been favored by increasing surgeons. When performing the resection, several principles such as restoring the original patellar thickness, avoiding over or under resection must be complied in order to achieve satisfactory outcomes.This study was conducted to compared the outcomes of two commonly adopted methods for performing patellar resection in total knee arthroplasty. One hundred patients with osteoarthritis were recruited in the clinical trial using Nexgen Legacy Posterior Stabilized-Flex prosthesis. Patients were randomized to receive "free-hand" technique and "resection guide" technique when performing patellar resection in total knee arthroplasty. Patients were evaluated preoperatively and at follow-up visits conducted at twelve months, at twenty-four months. Clinical outcome was assessed and compared with use of the visual analogue pain scale (VAS), range of motion, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 (SF-36). Patellar alignment was assessed before surgery and at each follow-up by measuring the patellar tilt (PT) and lateral patellar displacement (PD). Prosthetic position and leg alignment were also compared between the two groups.

Registry
clinicaltrials.gov
Start Date
October 29, 2014
End Date
July 15, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jia-kuo yu

Peking University Third Hospital

Peking University Third Hospital

Eligibility Criteria

Inclusion Criteria

  • diagnosis of primary osteoarthritis of the knee, with Ahlbäck grade of ≥2 (symptoms persisting after conservative treatment for at least 3 months) knees with \<20° varus or \<15° valgus deformity patellar thickness is more than 21mm

Exclusion Criteria

  • restricted motion (flexion contracture of \>25°) patella alta (Insall-Salvati ratio of \<0.6) history of previous knee surgery

Outcomes

Primary Outcomes

Patellar tilt (PT)

Time Frame: 1 year

The patellar tilt is the angle between the transverse axis of the patella and The patellar tilt is the angle between the transverse axis of the patella and the anterior intercondylar line.The PT was assessed by a blinded observer using 30° skyline radiographs.

Secondary Outcomes

  • Knee Society Score (KSS)(1 year)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(1 year)
  • visual analogue pain scale (VAS)(1 year)
  • Short Form-36 (SF-36)(1 year)
  • leg alignment(1 year)
  • prosthetic position(1 year)
  • Rang of motion(1 year)
  • patellar displacement (PD)(1 year)

Study Sites (1)

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