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OpenTrials
Completed

NCT Number: NCT04467970

Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy.

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Medial compartment osteoarthritis with exposed bone on both femur and tibia.
  • -Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
  • -Full thickness and good quality lateral cartilage present
  • -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

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

Treatment and study plan

Unicompartmental Knee Replacement

Procedure

Unicompartmental Knee Replacement involves replacement of the medial compartment of the knee in patients with anteromedial osteoarthritis.

High tibial osteotomy

Procedure

High Tibial Osteotomy involves medial wedge opening high tibial osteotomy in cases of anteromedial osteoarthritis.

Primary outcomes

  1. Pain and Function using Oxford Knee Score

    Time frame: 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 outcomes

  1. Range of Motion and Function using the American Knee Society Score.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2020
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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