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High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA

C

Centre of Postgraduate Medical Education

Status

Unknown

Conditions

Patellofemoral Disorder
Osteoarthritis, Knee

Treatments

Procedure: High Tibial Osteotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05128864
HTO_fulkerson

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

110 participants in 2 patient groups

HTO and Fulkerson
Active Comparator group
Description:
High Tibial Osteotomy with Antero-medialisation of Tibial Tubercle
Treatment:
Procedure: High Tibial Osteotomy
HTO
Sham Comparator group
Description:
Descending Hight Tibial Osteotomy
Treatment:
Procedure: High Tibial Osteotomy

Trial contacts and locations

1

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Central trial contact

Rafał Kamiński, MD PhD

Data sourced from clinicaltrials.gov

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