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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05094258

Enrollment

Registered

2021-10-26

Start date

2020-06-01

Completion date

2022-11-01

Last updated

2021-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Unicompartmental Knee osteoarthritis, Unicompartmental Knee prosthesis, Mobile insert, Fixed İnsert

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.

Interventions

PROCEDUREunicondylar knee prosthesis with mobile insert

Patients with unicondylar knee replacement using the mobile insert option

PROCEDUREunicondylar knee prosthesis with fixed insert

Patients with unicondylar knee replacement using the fixed insert option

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes 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.

Intervention 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

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

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

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Contacts

Primary ContactVolkan Ezici

volkanezicimd@gmail.com00905331508025

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026