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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Centre of Postgraduate Medical Education
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- KOOS
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Rafał Kamiński
Chair of Division
Centre of Postgraduate Medical Education
Eligibility Criteria
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
Outcomes
Primary Outcomes
KOOS
Time Frame: 24 months
Knee Injury and Osteoarthritis Outcome Score
VAS
Time Frame: 24 months
Visual Analog Scale
Blood test
Time Frame: 12 weeks,
no inflammatory reaction - CRP, Il-6, CTx
IKDC
Time Frame: 24 months
International Knee Documentation Committee - Subjective Knee Evaluation Form
Secondary Outcomes
- Kinematic MRI with [chondrogram](24 months)
- X-ray - Baldini projection(24 months)