Clinical trial NCT05128851: High Tibial Osteotomy With/Without Arthroscopy.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Meniscus; Degeneration
Keywords: HTO
Degenerative Meniscus
Osteoarthritis
Microfracture
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: KOOS
timeFrame: 12 months
measure: KOOS
timeFrame: 24 months
measure: IKDC
timeFrame: 12 months
measure: IKDC
timeFrame: 24 months
measure: VAS
timeFrame: 12 months
measure: VAS
timeFrame: 24 months
measure: Blood test
timeFrame: 2 day
measure: Blood test
timeFrame: 6 weeks
measure: Blood test
timeFrame: 12 weeks,
Secondary outcomes:
measure: Kinematic MRI with [chondrogram]
timeFrame: 2 day,
measure: Kinematic MRI with [chondrogram]
timeFrame: 24 months
measure: X-ray - Baldini projection
timeFrame: 2 day
measure: X-ray - Baldini projection
timeFrame: 24 months
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital
state: Mazowieckie
Study officials:
affiliation: PCME, Otwock, Poland
name: Rafał Kamiński
role: PRINCIPAL_INVESTIGATOR
References: