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NCT Number: NCT03600922

Clinical Study of Patellar Resurfacing and Non-resurfacing in 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.

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Key information

Conditions

Total Knee Arthroplasty Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the patella was resurfaced.

Procedure

Patellar resurfacing was undertaken using a cemented, inset domed component in TKA.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Liaocheng People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2017
First posted
Jul 26, 2018
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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