Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy.

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04467970
• Other study ID #: UKAVSHTOARCT
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthroplasty
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Unicompartmental Knee Replacement
Unicompartmental Knee Replacement involves replacement of the medial compartment of the knee in patients with anteromedial osteoarthritis.
• High Tibial Osteotomy
High Tibial Osteotomy involves medial wedge opening high tibial osteotomy in cases of anteromedial osteoarthritis.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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