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

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
unicondylar knee prosthesis with mobile insert
unicondylar knee prosthesis with fixed insert
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Unicompartmental Knee osteoarthritis, Unicompartmental Knee prosthesis, Mobile insert, Fixed İnsert

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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"

Sites / Locations

  • Volkan EziciRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

mobile insert

fixed insert

Arm Description

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

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

Outcomes

Primary Outcome Measures

Short Form Health Survey (SF-36)
SF-36 Score (0-100) to assess patient satisfaction at postoperative 1st year
Knee injury and osteoarthritis outcome score (KOOS)
Knee injury and osteoarthritis outcome score (0-100)

Secondary Outcome Measures

Full Information

First Posted
October 13, 2021
Last Updated
November 24, 2021
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05094258
Brief Title
Comparison of Early Results of Mobile and Fixed Insert Unicondylar Knee Prosthesis.
Official Title
Comparison of Early Clinical and Radiological Results and Patient Satisfaction of Mobile and Fixed Insert Unicondylar Knee Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Unicompartmental Knee osteoarthritis, Unicompartmental Knee prosthesis, Mobile insert, Fixed İnsert

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantOutcomes Assessor
Masking Description
After collecting all data about patients and patients participating in the study, the independent person who will evaluate the data will be blinded.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mobile insert
Arm Type
Active Comparator
Arm Description
Unicondylar knee arthroplasty with mobile insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.
Arm Title
fixed insert
Arm Type
Active Comparator
Arm Description
Unicondylar knee arthroplasty with fixed insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.
Intervention Type
Procedure
Intervention Name(s)
unicondylar knee prosthesis with mobile insert
Intervention Description
Patients with unicondylar knee replacement using the mobile insert option
Intervention Type
Procedure
Intervention Name(s)
unicondylar knee prosthesis with fixed insert
Intervention Description
Patients with unicondylar knee replacement using the fixed insert option
Primary Outcome Measure Information:
Title
Short Form Health Survey (SF-36)
Description
SF-36 Score (0-100) to assess patient satisfaction at postoperative 1st year
Time Frame
0-1 year
Title
Knee injury and osteoarthritis outcome score (KOOS)
Description
Knee injury and osteoarthritis outcome score (0-100)
Time Frame
0-1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Volkan Ezici
Phone
00905331508025
Email
volkanezicimd@gmail.com
Facility Information:
Facility Name
Volkan Ezici
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
3344
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
volkan Ezici
Phone
00905331508025
Email
volkanezicimd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participant data will not be shared

Learn more about this trial

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

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