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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05128851
Other study ID # HTO_artro
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2020
Est. completion date May 30, 2022

Study information

Verified date November 2021
Source Centre of Postgraduate Medical Education
Contact Rafal Kaminski
Phone +48227794031
Email rkaminski@spskgruca.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Procedure:
HTO
Hight Tibial Osteotomy
Arthroscopy treatment
Arthroscopy treatment
Micro fractures
Micro fractures

Locations

Country Name City State
Poland Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital Otwock Mazowieckie

Sponsors (1)

Lead Sponsor Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary KOOS Knee Injury and Osteoarthritis Outcome Score 12 months
Primary KOOS Knee Injury and Osteoarthritis Outcome Score 24 months
Primary IKDC International Knee Documentation Committee - Subjective Knee Evaluation Form 12 months
Primary IKDC International Knee Documentation Committee - Subjective Knee Evaluation Form 24 months
Primary VAS Visual Analog Scale 12 months
Primary VAS Visual Analog Scale 24 months
Primary Blood test no inflammatory reaction - CRP, Il-6, CTx 2 day
Primary Blood test no inflammatory reaction - CRP, Il-6, CTx 6 weeks
Primary Blood test no inflammatory reaction - CRP, Il-6, CTx 12 weeks,
Secondary Kinematic MRI with [chondrogram] Meniscus healing, cartilage quality 2 day,
Secondary Kinematic MRI with [chondrogram] Meniscus healing, cartilage quality 24 months
Secondary X-ray - Baldini projection Patellofemoral joint measurements 2 day
Secondary X-ray - Baldini projection Patellofemoral joint measurements 24 months
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