Comparison of Early Results of Mobile and Fixed Insert Unicondylar Knee Prosthesis.
Comparison of Early Clinical and Radiological Results and Patient Satisfaction of Mobile and Fixed Insert Unicondylar Knee Prosthesis
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Jun 2020
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedNovember 30, 2021
November 1, 2021
1.5 years
October 13, 2021
November 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Short Form Health Survey (SF-36)
SF-36 Score (0-100) to assess patient satisfaction at postoperative 1st year
0-1 year
Knee injury and osteoarthritis outcome score (KOOS)
Knee injury and osteoarthritis outcome score (0-100)
0-1 year
Study Arms (2)
mobile insert
ACTIVE COMPARATORUnicondylar knee arthroplasty with mobile insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.
fixed insert
ACTIVE COMPARATORUnicondylar knee arthroplasty with fixed insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.
Interventions
Patients with unicondylar knee replacement using the mobile insert option
Patients with unicondylar knee replacement using the fixed insert option
Eligibility Criteria
You may qualify if:
- Patients with degenerative knee arthritis with only one compartment affected
You may not qualify if:
- 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"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Volkan Ezici
Istanbul, Fatih, 3344, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- After collecting all data about patients and patients participating in the study, the independent person who will evaluate the data will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- orthopaedic surgeon
Study Record Dates
First Submitted
October 13, 2021
First Posted
October 26, 2021
Study Start
June 1, 2020
Primary Completion
December 1, 2021
Study Completion
November 1, 2022
Last Updated
November 30, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share
Participant data will not be shared