Clinical Study of Patellar Resurfacing and Non-resurfacing in Total Knee Arthroplasty

July 25, 2018 updated by: Liaocheng People's Hospital

A Prospective Randomized Clinical Study of Patellar Resurfacing and Non-resurfacing in One-stage Bilateral Total Knee Arthroplasty

The literature regarding resurfacing of the patella in total knee arthroplasty has conflicting conclusions. This study assesses medium-term clinical results of total knee arthroplasties performed with and without the patellar resurfacing in patients undergoing single-staged bilateral total knee arthroplasty in a randomized controlled, clinical study at a minimum of 5 years follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sixty-six patients (132 knees) underwent primary single-staged bilateral total knee arthroplasty for osteoarthritis. Patients were randomized to receive resurfacing or retention of the patella. All patients received the Scorpio NRG knee prosthesis. Evaluations were done preoperatively and yearly, up to a minimum of 5 years postoperatively. Knee Society Score and Feller Score outcomes were measured. Anterior knee pain, the clunk of patella, and patient satisfaction questionnaires were completed.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • degenerative OA
  • 50-75 years
  • All patients with OA were bilateral knee OA

Exclusion Criteria:

  • previous patellectomy
  • inflammatory arthritis
  • patellar fracture
  • patellar instability
  • previous extensor mechanism procedures
  • high tibial osteotomy,
  • severe valgus or varus deformity (> 20°), severe flexion contracture (> 30°)
  • previous unicondylar knee replacement
  • a history of septic arthritis or osteomyelitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Procedure: the patella was resurfaced.
Patellar resurfacing was undertaken using a cemented, inset domed component in TKA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Feller score
Time Frame: Baseline,1,2,3,4 and 5 years
The Feller score consists four parts.Total score is 30 score (0-30) and the higher values represent a better outcome. The Feller score has points for Anterior knee pain (0 worst-15 best), quadriceps strength (1 worst -5 best) , ability to rise from chairand stability(0 worst-5 best )and stair-climbing(2 worst-5 best ). The scores from each item are summed to produce a total score
Baseline,1,2,3,4 and 5 years
Change From Baseline in visual analogue scale (VAS)
Time Frame: Baseline,1,2,3,4 and 5 years
The Visual analogue scale (VAS)is ranging from 0 to 10 points, with 0 being no pain and 10 being maximum pain.The higher values represent a worse outcome.
Baseline,1,2,3,4 and 5 years
Change From Baseline in knee society score ( KSS)
Time Frame: Baseline,1,2,3,4 and 5 years
The knee society score ( KSS) which consists of a 100-point scale for knee score and 100-point score for function score. The knee score has points for pain (0 worst -50 best ), range of motion (0 worst -25 best ) and stability (0 worst -25 best ). scores from each item are summed to produce a total score .The function score has points for walking ability (0 worst -50 best ) and stair climbing ability (0 worst -50 best ), scores from each item are summed to produce a total score.The knee score and the function score are recorded respectively.The higher values represent a better outcome.
Baseline,1,2,3,4 and 5 years
Change From Baseline in anteroposterior long weight-bearing X-ray
Time Frame: Baseline,1,2,3,4 and 5 years
anteroposterior long weight-bearing X-ray
Baseline,1,2,3,4 and 5 years
Change From Baseline in MOS item short from health survey(SF-36)
Time Frame: Baseline,1,2,3,4 and 5 years
The MOS item short from health survey(SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
Baseline,1,2,3,4 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaocheng People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 1, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2018

Last Update Submitted That Met QC Criteria

July 25, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LCHOSPITAL-123456

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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