NCT03600922

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

June 1, 2018

Last Update Submit

July 25, 2018

Conditions

Total Knee Arthroplasty

Keywords

OsteoarthritisPatellar resurfacingAnterior knee pain

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • Change From Baseline in anteroposterior long weight-bearing X-ray

    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)

    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

Study Arms (1)

Intervention group

EXPERIMENTAL
Procedure: the patella was resurfaced.

Interventions

the patella was resurfaced.PROCEDURE

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

Intervention group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • degenerative OA
  • years
  • All patients with OA were bilateral knee OA

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ha C, Wang B, Li W, Sun K, Wang D, Li Q. Resurfacing versus not-resurfacing the patella in one-stage bilateral total knee arthroplasty: a prospective randomized clinical trial. Int Orthop. 2019 Nov;43(11):2519-2527. doi: 10.1007/s00264-019-04361-7. Epub 2019 Jun 21.

    PMID: 31227852DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2018

First Posted

July 26, 2018

Study Start

March 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2017

Last Updated

July 27, 2018

Record last verified: 2018-07