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Bi unicondylar knee arthroplasty versus Total knee arthroplasty: A Randomized Clinical Trial

Bi unicondylar knee arthroplasty versus Total knee arthroplasty: A Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230926059523N1
Enrollment
26
Registered
2023-11-30
Start date
2023-12-16
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Knee osteoarthritis - knee joint replacement. Unilateral primary osteoarthritis, unspecified knee

Interventions

Intervention 1: Intervention group: The leg that has the most pain is subjected to bi-UKA operation in such a way that the medial and lateral condyles of the knee are replaced with unicondylar prosthe

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with medial and lateral OA suitable for treatment with standard unrestricted TKA Healthy cruciate ligaments (based on radiological evidence and clinical examination) Willing and able to provide informed consent

Exclusion criteria

Exclusion criteria: Patients with rheumatoid arthritis or other inflammatory arthropathy Varus or valgus deformity greater than 15 degrees Flexion contracture greater than 10 degrees Single-compartment OA suitable for isolated UKA Radiological evidence of Kelgren and Lawrence grade III OA of the patellar joint Patients who had undergone previous knee surgery that might affect the outcome of the arthroplasty, such as anterior or posterior cruciate ligament reconstruction Who had significant OA of the spine or other lower extremity joints were not included in the study Despite the diagnostic measures before the operation, if there is a clear ligament damage that makes the condition unfavorable for bi-uka surgery, the patient will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
KOOS (knee injury and osteoarthritis outcome) questionnaire score including daily activity, sports activity, pain, quality of life, symptoms and joint stiffness before and after surgery. Timepoint: After 1 month and 6 months from the last operation, the patient is followed up with frequent visits. And questionnaires related to patient function and pain will be filled for both legs. Method of measurement: Clinical records, pre- and post-surgery graphs,lab tests, questionnaires.

Secondary

MeasureTime frame
Blood loss during and after surgery. Timepoint: Before, 1 day and 1 week after the operation. Method of measurement: Laboratory data.;Duration of surgery. Timepoint: During the operation, from the time of skin incision to wound closure. Method of measurement: clock.;Anatomical and mechanical angles and alignment of the knee joint. Timepoint: Before and after surgery. Method of measurement: standing 3-joint Aligment view graphs (hip-knee-ankle).

Countries

Iran (Islamic Republic of)

Contacts

Public Contactali ghanei tehrani

Shahid Beheshti University of Medical Sciences

alighaneitehrani@sbmu.ac.ir+98 21 7343 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026