NCT04637490

Brief Summary

For decades there have been concerns about patellar resurfacing (PR) in total knee arthroplasty (TKA) and the individual preference of the surgeon is still the main determinant of whether or not resurfacing is applied. According to preference, surgeons can be categorized in 3 main groups of those who usually, selectively or rarely resurface. The aim of this prospective, randomized, controlled study to is compare the isokinetic performance and clinical outcome of TKAs with PR and without PR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

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

June 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

November 9, 2020

Last Update Submit

November 18, 2020

Conditions

Knee Osteoarthritis

Keywords

patellar resurfacingisokinetic testing

Outcome Measures

Primary Outcomes (1)

  • isokinetic test

    isokinetic test during extension and flexion of the knee

    Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results

Secondary Outcomes (1)

  • Knee Society Score (KSS): It has two different subscales: Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor

    Change from preoperative KSS results at 3rd months, 6th months and 12th months KSS results

Study Arms (2)

patellar resurfacing

EXPERIMENTAL

patellar resurfacing in TKA

Device: patellar component

non-resurfacing

NO INTERVENTION

non-resurfacing TKA

Interventions

patellar componentDEVICE

patellar resurfacing

patellar resurfacing

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 55 to 80 years
  • unilateral primary osteoarthritis

You may not qualify if:

  • bilateral osteoarthritis
  • inflammatory arthritis
  • post-traumatic osteoarthritis
  • previous knee surgery
  • neuromuscular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Teaching and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Deniz CANKAYA, Assoc.Professor

    Gulhane Teaching and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 19, 2020

Study Start

June 1, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)