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Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores

NCT ID: NCT04637490

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-11-01

Brief Summary

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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.

Detailed Description

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Patients undergoing TKA for primary osteoarthritis of the knee are randomly assigned to either the PR or non-PR groups. The differences between groups with respect to age, BMI, gender, and preoperative Knee Society Score (KSS), and isokinetic performance are evaluated. Patients are evaluated at postoperative 3, 6, and 12 months with KSS and at 6 months and 1 year with isokinetic measurements.

Conditions

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Knee Osteoarthritis

Keywords

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patellar resurfacing isokinetic testing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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patellar resurfacing

patellar resurfacing in TKA

Group Type EXPERIMENTAL

patellar component

Intervention Type DEVICE

patellar resurfacing

non-resurfacing

non-resurfacing TKA

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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patellar component

patellar resurfacing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 55 to 80 years
* unilateral primary osteoarthritis

Exclusion Criteria

* bilateral osteoarthritis
* inflammatory arthritis
* post-traumatic osteoarthritis
* previous knee surgery
* neuromuscular diseases
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gulhane Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Deniz CANKAYA

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deniz CANKAYA, Assoc.Professor

Role: PRINCIPAL_INVESTIGATOR

Gulhane Teaching and Research Hospital

Locations

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Gulhane Teaching and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-17-1414

Identifier Type: -

Identifier Source: org_study_id