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High Tibial Osteotomy With/Without Arthroscopy.

C

Centre of Postgraduate Medical Education

Status

Unknown

Conditions

Meniscus; Degeneration
Osteoarthritis, Knee

Treatments

Procedure: Micro fractures
Procedure: Arthroscopy treatment
Procedure: HTO

Study type

Interventional

Funder types

Other

Identifiers

NCT05128851
HTO_artro

Details and patient eligibility

About

This study will compare Hight Tibial Osteotomy with or without arthroscopically repair intra-articular knee lesions in patients with early stages of Osteoarthritis.The purpose of this study is evaluate if addition of arthroscopy to HTO provides better clinical, radiological and laboratory outcomes.

Full description

Intraarticular knee lesions are often in patients with early stages of osteoarthritis. The most frequent findings are degenerative meniscus/meniscal tears and cartilage degeneration. Degenerative meniscal lesions or meniscal tears are often incidental findings without any complains from patients. In the current literature there is no evidence for good clinical outcomes after arthroscopically treatment degenerative meniscus. Cartilage injuries are common in osteoarthritic knee and depending on grading of chondromalacia are usually treated by microfractures. By this time the choice of performed surgery depends on surgeons personal assessment. The investigators believe that concomitant intraarticular procedures added to HTO will provide better clinical outcomes.

Enrollment

90 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
  • Intraarticular lesions in MRI
  • 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
  • multilligament 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

90 participants in 3 patient groups

High Tibial Osteotomy and arthroscopy
Active Comparator group
Description:
High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions.
Treatment:
Procedure: Arthroscopy treatment
Procedure: HTO
High Tibial Osteotomy
Sham Comparator group
Description:
Descending High Tibial Osteotomy with arthroscopy without treatment of intraarticular lesions.
Treatment:
Procedure: HTO
High Tibial Osteotomy, arthroscopy and microfractures
Active Comparator group
Description:
High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture.
Treatment:
Procedure: Arthroscopy treatment
Procedure: Micro fractures
Procedure: HTO

Trial contacts and locations

1

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Central trial contact

Rafał Kamiński

Data sourced from clinicaltrials.gov

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