High Tibial Osteotomy With/Without Arthroscopy.

Not Applicable

• Conditions: Osteoarthritis, Knee; Meniscus; Degeneration
• Interventions: Procedure: HTO; Procedure: Arthroscopy treatment; Procedure: Micro fractures

• Registration Number: NCT05128851
• Lead Sponsor: Centre of Postgraduate Medical Education

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.

Study Timeline

• Study First Submitted: 2020-07-03
• Study Start: 2020-07-15
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-09
• Last Update Submitted: 2021-11-09
• Study First Posted: 2021-11-22
• Last Update Posted: 2021-11-22
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Tibial Osteotomy, arthroscopy and microfractures	Arthroscopy treatment	High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture.
High Tibial Osteotomy, arthroscopy and microfractures	HTO	High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture.
High Tibial Osteotomy, arthroscopy and microfractures	Micro fractures	High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture.
High Tibial Osteotomy and arthroscopy	Arthroscopy treatment	High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions.
High Tibial Osteotomy and arthroscopy	HTO	High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions.
High Tibial Osteotomy	HTO	Descending High Tibial Osteotomy with arthroscopy without treatment of intraarticular lesions.

Primary Outcome Measures

Name	Time	Method
KOOS	24 months	Knee Injury and Osteoarthritis Outcome Score
VAS	24 months	Visual Analog Scale
Blood test	12 weeks,	no inflammatory reaction - CRP, Il-6, CTx
IKDC	24 months	International Knee Documentation Committee - Subjective Knee Evaluation Form

Secondary Outcome Measures

Name	Time	Method
Kinematic MRI with [chondrogram]	24 months	Meniscus healing, cartilage quality
X-ray - Baldini projection	24 months	Patellofemoral joint measurements

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital; 🇵🇱 Otwock, Mazowieckie, Poland