High Tibial Osteotomy With/Without Arthroscopy.

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05128851
• Other study ID #: HTO_artro
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Meniscus; Degeneration
• Osteoarthritis
• Osteoarthritis, Knee

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