Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy.

Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis; Knee Arthroplasty
• Intervention / Treatment: Procedure: Unicompartmental Knee Replacement; Procedure: High Tibial Osteotomy

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unicompartmental Knee Replacement	Procedure: Unicompartmental Knee Replacement; Unicompartmental Knee Replacement involves replacement of the medial compartment of the knee in patients with anteromedial osteoarthritis.
Experimental: High Tibial Osteotomy	Procedure: High Tibial Osteotomy; High Tibial Osteotomy involves medial wedge opening high tibial osteotomy in cases of anteromedial osteoarthritis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and Function using Oxford Knee Score	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)	at least two year follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion and Function using the American Knee Society Score.	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.	at least two year follow up

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Unicompartmental knee Replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: UKAVSHTOARCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No