High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA

Not Applicable

• Conditions: Patellofemoral Disorder; Osteoarthritis, Knee
• Interventions: Procedure: High Tibial Osteotomy

• Registration Number: NCT05128864
• Lead Sponsor: Centre of Postgraduate Medical Education

Brief Summary

This study will compare Hight Tibial Osteotomy with or without Fulkerson Osteotomy performed on patients with early stages of Osteoarthritis with patellofemoral joint disorders. The purpose of this study is evaluate which type of osteotomy provides better clinical, radiological and laboratory outcomes.

Detailed Description

Progression of knee cartilage degenerative changes leads to necessary total knee arthroplasty in future, which is the most popular procedure for treating OA. HTO applied at early stages of osteoarthritis allow slow down cartilage degeneration process, but the choice of performed surgery depends on surgeons personal assessment. Patellofemoral Pain Syndrome often occurs with knee arthritis. Antero-medialisation of tibial tubercle is frequent procedures for patella maltracking. So far, both, HTO and Fulkerson osteotomy was performed separately, even if patient have symptoms from patellofemoral joint and OA. The investigators believe that simultaneously surgery of HTO and fulkerson Osteotomy provides better outcomes and significantly slow down knee degeneration.

Study Timeline

• Study Start: 2020-07-15
• Study First Submitted: 2020-07-18
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-09
• Last Update Submitted: 2021-11-09
• Study First Posted: 2021-11-22
• Last Update Posted: 2021-11-22
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination
• Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests

Exclusion Criteria

• no informed consent to participate in the study
• age under 18 years or above 65
• multi ligament injury or single plane knee instability
• another musculoskeletal disorders in lower limb
• lower limb deformity requiring axis correction below 4o or above 12.5o
• joints inflammatory diseases
• ASA score > II

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HTO and Fulkerson	High Tibial Osteotomy	High Tibial Osteotomy with Antero-medialisation of Tibial Tubercle
HTO	High Tibial Osteotomy	Descending Hight Tibial Osteotomy

Primary Outcome Measures

Name	Time	Method
Biomechanics MRI	2 years	Patellofemoral Joints Biomechanics improvement measured
Biomechanics X-ray	24 months	Patellofemoral Joints Biomechanics improvement measured

Secondary Outcome Measures

Name	Time	Method
KOOS	24 months	Knee Injury and Osteoarthritis Outcome Score
IKDC	24 months	International Knee Documentation Committee
Tegner Lysholm	24 months	Tegner Lysholm Knee Scoring Scale
SF-36	24 months	The Short Form (36) Health Survey
VAS	24 months	Pain Visual Analog Scale
Blood test	6 weeks	CRP, IL-6, CTx

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital; 🇵🇱 Otwock, Mazowieckie, Poland