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

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Procedure: the patella was resurfaced.

• Registration Number: NCT03600922
• Lead Sponsor: Liaocheng People's Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2011-03
• Primary Completion: 2012-08
• Study Completion: 2017-08
• Study First Submitted: 2018-06-01
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-17
• Last Update Submitted: 2018-07-25
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	the patella was resurfaced.	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in anteroposterior long weight-bearing X-ray	Baseline,1,2,3,4 and 5 years	anteroposterior long weight-bearing X-ray
Change From Baseline in knee society score ( KSS)	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.
Change From Baseline in the Feller score	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
Change From Baseline in visual analogue scale (VAS)	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.
Change From Baseline in MOS item short from health survey(SF-36)	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.