Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy.

Not Applicable

Completed

• Conditions: Knee Arthroplasty; Knee Osteoarthritis
• Interventions: Procedure: Unicompartmental Knee Replacement; Procedure: High Tibial Osteotomy

• Registration Number: NCT04467970
• Lead Sponsor: Assiut University

Brief Summary

Valgus high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are established treatment options for patients with medial compartmental osteoarthritis (OA) of the knee.However, the clinical outcomes of these treatment modalities for unicompartmental OA have become subjects of debate.

Detailed Description

Although HTO for the correction of malalignment in the medial osteoarthritic knee has been shown to provide successful outcomes in some studies, it is technically difficult to achieve the ideal valgus position postoperatively, and the likelihood of postoperative complications after HTO is greater than that after UKA . As compared with HTO, UKA has been reported to provide better long-term results, to have a shorter time to full weight bearing, to allow easier rehabilitation, and to have fewer perioperative complications. Furthermore, indications for UKA are broadening, including younger and more active patients, since encouraging midterm and long-term results were published.

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Study Start: 2020-10-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-04
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. • Medial compartment osteoarthritis with exposed bone on both femur and tibia.
2. -Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
3. -Full thickness and good quality lateral cartilage present
4. -Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament) 5-Medically fit showing an American Society of Anesthesiologists (ASA) of 1 or 2

Exclusion Criteria

1. Require revision knee replacement surgery.
2. Have rheumatoid arthritis or other inflammatory disorders.
3. Are unlikely to be able to perform required clinical assessment tasks.
4. Have symptomatic foot, hip or spinal pathology.
5. Previous knee surgery other than diagnostic arthroscopy and medial menisectomy.
6. Previously had septic arthritis.
7. Have significant damage to the patella-Femoral Joint especially on the lateral facet.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unicompartmental Knee Replacement	Unicompartmental Knee Replacement	-
High Tibial Osteotomy	High Tibial Osteotomy	-

Primary Outcome Measures

Name	Time	Method
Pain and Function using Oxford Knee Score	at least two year follow up.	this will be measured by using the Oxford Knee Score, a patient reported outcome questionnairewhich is A patient reported outcome measure highest score that could a patient get is 48 and means that good outcome and the lowest score to be obtained is 0 whick means poor outcome ( the higher the score,the better the outcome)

Secondary Outcome Measures

Name	Time	Method
Range of Motion and Function using the American Knee Society Score.	at least two year follow up	this will be measured using the American Knee Society Score (AKSS). A clinician assessed score examining pain, stability, range of movement and function in which the maximum score to get is 100 and least score to get is 0 and the higher the score the better the outcome.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt