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

Bezmialem Vakif University

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Procedure: unicondylar knee prosthesis with mobile insert; Procedure: unicondylar knee prosthesis with fixed insert

Study type: Interventional

Funder types: Other

Identifiers

NCT05094258

61813471876

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No 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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

mobile insert

Active Comparator group

Description:

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

Treatment:

Procedure: unicondylar knee prosthesis with mobile insert

fixed insert

Active Comparator group

Description:

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

Treatment:

Procedure: unicondylar knee prosthesis with fixed insert