Osteoarthritis, Knee Clinical Trial
Official title:
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Arthroscopic Treatment of Knee Intraarticular Lesions.
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital | Otwock | Mazowieckie |
Lead Sponsor | Collaborator |
---|---|
Centre of Postgraduate Medical Education |
Poland,
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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