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Comparison of Early Results of Mobile and Fixed Insert Unicondylar Knee Prosthesis.

NCT ID: NCT05094258

Last Updated: 2021-11-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-11-01

Brief Summary

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Comparison of the early clinical and radiological results and patient satisfaction of the mobile and fixed insert unicondylar knee prostheses routinely used in the clinic.

Detailed Description

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Unicondylar knee prosthesis operation will be performed on patients with unicompartmental knee arthrosis who apply to our clinic. Patients will be randomized to use mobile or fixed inserts. After 1 year of follow-up, SF-36, KOOS and HSS scores will be taken to examine the clinical satisfaction of the patients. In addition, radiological evaluation will be made for the presence of osteolysis at the tibial implant interface between both groups.

Conditions

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Knee Osteoarthritis

Keywords

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Unicompartmental Knee osteoarthritis Unicompartmental Knee prosthesis Mobile insert Fixed İnsert

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with medial knee arthrosis will be randomized to receive unicompartmental knee prosthesis using mobile inserts in 30 patients and fixed inserts in 30 patients. Patients will be evaluated after at least 1 year of follow-up
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
After collecting all data about patients and patients participating in the study, the independent person who will evaluate the data will be blinded.

Study Groups

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mobile insert

Unicondylar knee arthroplasty with mobile insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.

Group Type ACTIVE_COMPARATOR

unicondylar knee prosthesis with mobile insert

Intervention Type PROCEDURE

Patients with unicondylar knee replacement using the mobile insert option

fixed insert

Unicondylar knee arthroplasty with fixed insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.

Group Type ACTIVE_COMPARATOR

unicondylar knee prosthesis with fixed insert

Intervention Type PROCEDURE

Patients with unicondylar knee replacement using the fixed insert option

Interventions

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unicondylar knee prosthesis with mobile insert

Patients with unicondylar knee replacement using the mobile insert option

Intervention Type PROCEDURE

unicondylar knee prosthesis with fixed insert

Patients with unicondylar knee replacement using the fixed insert option

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with degenerative knee arthritis with only one compartment affected

Exclusion Criteria

* Inflammatory Arthritis
* Tricompartmental arthritis
* Patients with fixed varus deformity greater than -10 degrees
* Patients with fixed valgus deformity greater than -5 degrees
* Patients with knee range of motion less than 90 degrees
* Patients with more than 10 degrees of flexion contracture"
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Murat Sarikas

orthopaedic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Volkan Ezici

Istanbul, Fatih, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Volkan Ezici

Role: CONTACT

Phone: 00905331508025

Email: [email protected]

Facility Contacts

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volkan Ezici

Role: primary

Other Identifiers

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61813471876

Identifier Type: -

Identifier Source: org_study_id