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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600922
• Other study ID #: LCHOSPITAL-123456
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: August 2017

Study information

• Verified date: July 2018
• Source: Liaocheng People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2017
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Procedure:
• the patella was resurfaced.
Patellar resurfacing was undertaken using a cemented, inset domed component in TKA.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Liaocheng People's Hospital

Outcome

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